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A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

ABBV-8E12

placebo for ABBV-8E12

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Early Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI), Mild Alzheimer's Disease (AD), Tau, Early dementia, Tauopathies, AD, Neurodegenerative diseases, Memory loss, Nervous system diseases

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject who meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have:
- Clinical Dementia Rating (CDR)-Global Score of 0.5
- Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive
- Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory Index (RBANS - DMI) score of 85 or lower
Subject has a positive amyloid positron emission tomography (PET) scan.
Subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4.
The subject has an identified, reliable, study partner (e.g., family member).
If using medications to treat symptoms related to AD, doses must be stable for at least 12 weeks prior to randomization.

Exclusion Criteria:

Subject has any contraindications or inability to tolerate brain magnetic resonance imaging (MRI), PET scans or lumbar puncture.
Subject has evidence of any other clinically significant neurological disorder other than early AD.
In the opinion of the investigator, the subject has any clinically significant or uncontrolled medical or psychiatric illness, or has had an infection requiring medical intervention in the past 30 days.
Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of Screening.

Sites / Locations

Banner University of Arizona Medical Center Phoenix /ID# 151536
Banner Sun Health Res Inst /ID# 151895
Irvine Clinical Research /ID# 162331
Ucsd /Id# 152467
Ray Dolby Brain Health Center /ID# 154965
Univ California, San Francisco /ID# 152053
Brain Matters Research /ID# 147796
Neuropsychiatric Research Center of Southwest Florida /ID# 162332
Mayo Clinic /ID# 151236
Synexus Clinical Research US, Inc. /ID# 147804
University of South Florida /ID# 151890
Synexus Clinical Research US, Inc /ID# 151633
Emory Midtown Infectious Disease Clinic /ID# 151492
Atlanta Center for Medical Research /ID# 151550
NeuroStudies.net, LLC /ID# 152746
Great Lakes Clinical Trials /ID# 152754
Advocate Lutheran General Hospital /ID# 152052
Southern IL Univ School of Med /ID# 151769
Indiana University /ID# 151861
University of Kansas Medical Center - Alzheimer's Disease Center /ID# 151554
University of Kentucky Chandler Medical Center /ID# 152753
Johns Hopkins Bayview Med Cnt /ID# 151893
Massachusetts General Hospital /ID# 151770
Brigham and Women's Physicians /ID# 151882
Hattiesburg Clinic /ID# 202388
Princeton Medical Institute /ID# 152934
Scott Research Inc. /ID# 151880
North Shore University Hospital /ID# 151632
Duke Cancer Center /ID# 147828
Oregon Health and Science University /ID# 151690
Keystone Clinical Studies LLC /ID# 202305
Rhode Island Hospital /ID# 151538
Vanderbilt University Medical Center /ID# 154547
Kerwin Research Center /ID# 147815
Houston Methodist Hospital /ID# 154810
McGovern Medical School /ID# 204860
University of Utah /ID# 151858
Integrated Neurology Services /ID# 154863
The Kinghorn Cancer Centre /ID# 152632
Griffith University /ID# 152635
Austin Health /ID# 152637
The Royal Melbourne Hospital /ID# 202633
Australian Alzheimer's Res Fou /ID# 152634
Neurodegenerative Disorders Research /ID# 152826
UCL Saint-Luc /ID# 152847
Universitair Ziekenhuis Leuven /ID# 152642
Groupe Sante CHC - Clinique du MontLegia /ID# 152846
Parkwood Institute /ID# 164204
Toronto Memory Program /ID# 147863
Rigshospitalet /ID# 153192
Clinical Research Services Turku /ID# 152845
Ita-Suomen Yliopisto /ID# 152959
AOU di Modena /ID# 152394
Policlinico Agostino Gemelli /ID# 152396
Duplicate_AOU Policlinico Umberto I /ID# 163144
Azienda Ospedaliera di Perugia /ID# 152397
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli /ID# 152395
ASST Grande Ospedale Metropolitano Niguarda /ID# 152391
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 152401
Universitair Medisch Centrum Utrecht /ID# 163576
CGM Research Trust /ID# 152827
Fundacion CITA Alzheimer Fundazioa /ID# 152645
Fundacio ACE /ID# 152643
Hospital Clinic de Barcelona /ID# 152646
Hospital Clinico Universitario San Carlos /ID# 153703
Hospital Universitario 12 de Octubre /ID# 152647
Karolinska University Hospital Huddinge /ID# 156705
Sahlgrenska University Hospital Molndal /ID# 154465

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

ABBV-8E12 300 mg

ABBV-8E12 1000 mg

ABBV-8E12 2000 mg

Arm Description

Placebo for ABBV-8E12 every 4 weeks for 96 weeks

ABBV-8E12 300 mg every 4 weeks for 96 weeks

ABBV-8E12 1000 mg every 4 weeks for 96 weeks

ABBV-8E12 2000 mg every 4 weeks for 96 weeks

Outcomes

Primary Outcome Measures

Change From Baseline Over Time in CDR-SB Score

The CDR-SB is a numeric scale used to quantify the severity of symptoms of dementia. A qualified health professional assesses a participant's cognitive and functional performance in 6 areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The CDR scale gives a score from 0 to 3 for each of the 6 areas, with a lower value being desirable. The sum of these 6 areas, the CDR-SB score, can range from 0 to 18, with a lower value being desirable.

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

A TEAE was defined as an adverse event (AE) that began on or after the first study drug dose date and no more than 20 weeks after the last dose of study drug. An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. Serious AEs (SAEs) were defined as an event that results in death, is life-threatening, results in hospitalization or prolongs hospitalization, is a congenital abnormality, results in persistent or significant disability/incapacity, or is an important medical event. Events were rated in severity as mild, moderate, or severe, and were categorized as having a reasonable possibility or no reasonable possibility of relationship to study drug.

Secondary Outcome Measures

Maximum Observed Serum Concentration (Cmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Time to Cmax (Tmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Serum Concentration at the End of a Dose Interval (Ctrough) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Half-Life (T1/2) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Harmonic mean is presented in the data table.

Area Under the Concentration-Time Curve From Dosing (Time 0) to Day 28 (AUC0-28) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

The AUC0-28 for Dose 1 included the following timepoints: pre-infusion, post-infusion (within 15 min), 1 and 2 hours post-infusion, Day 5, Day 15 and Day 29 (trough level before Dose 2). The AUC0-28 for Dose 4 included the following timepoints: Day 85 pre-infusion, post-infusion (within 15 min), 1 and 2 hours post-infusion, Day 89, Day 99 and Day 113 (trough level before Dose 5).

Cmax/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

AUC0-28/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

The AUC0-28/dose for Dose 1 included the following timepoints: pre-infusion, post-infusion (within 15 min), 1 and 2 hours post-infusion, Day 5, Day 15 and Day 29 (trough level before Dose 2). The AUC0-28/dose for Dose 4 included the following timepoints: Day 85 pre-infusion, post-infusion (within 15 min), 1 and 2 hours post-infusion, Day 89, Day 99 and Day 113 (trough level before Dose 5).

Change From Baseline Over Time in Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) Total Score

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in mild cognitive impairment (MCI) patients. The Total Score of the ADAS-Cog-14 ranges from 0 to 90, with a higher score representing greater impairment.

Change From Baseline Over Time in ADAS-Cog-14 Comprehension of Spoken Language Score

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Comprehension of Spoken Language score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Change From Baseline Over Time in ADAS-Cog-14 Constructional Praxis Score

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Constructional Praxis Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Change From Baseline Over Time in ADAS-Cog-14 Commands Score

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Commands Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Change From Baseline Over Time in ADAS-Cog-14 Delayed Word Recall Score

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Delayed Word Recall Score of the ADAS-Cog-14 ranges from 0 to 10, with a higher score representing greater impairment.

Change From Baseline Over Time in ADAS-Cog-14 Ideational Praxis Score

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Ideational Praxis Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Change From Baseline Over Time in ADAS-Cog-14 Maze Task Score

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Maze Task Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Change From Baseline Over Time in ADAS-Cog-14 Number Cancellation Score

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Number Cancellation Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Change From Baseline Over Time in ADAS-Cog-14 Naming Score

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Naming Score of the ADAS-Cog-14 ranges from 0 to 5 with a higher score representing greater impairment.

Change From Baseline Over Time in ADAS-Cog-14 Orientation Score

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Orientation Score of the ADAS-Cog-14 ranges from 0 to 8, with a higher score representing greater impairment.

Change From Baseline Over Time in ADAS-Cog-14 Word Recall - Number of Words Not Recalled Score

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Recall - Number of Words Not Recalled Score of the ADAS-Cog-14 ranges from 0 to 10, with a higher score representing greater impairment.

Change From Baseline Over Time in ADAS-Cog-14 Remember Word Recognition Instructions Score

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Remember Word Recognition Instructions Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Change From Baseline Over Time in ADAS-Cog-14 Spoken Language Ability Score

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Spoken Language Ability Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Change From Baseline Over Time in ADAS-Cog-14 Word Find Difficulty Spontaneous Speech Score

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Find Difficulty Spontaneous Speech Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Change From Baseline Over Time in ADAS-Cog-14 Word Recognition Score

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Recognition Score of the ADAS-Cog-14 ranges from 0 to 12, with a higher score representing greater impairment.

Change From Baseline Over Time in Functional Activities Questionnaire (FAQ) Score

The FAQ measures level of assistance (functional disability) needed for carrying out instrumental activities in daily living (iADLs). The FAQ score ranges from 0 - 30 and consists of 10 items (each scored from 0 - 3), which measure a specific iADL in the past 4-weeks: [1) writing checks, paying bills, keeping financial records; 2) assembling tax or business records; 3) shopping alone; 4) playing a game of skill; 5) making coffee or tea; 6) preparing a balanced meal; 7) keeping track of current events; 8) attending to and understanding a television program, book, or magazine; 9) remembering appointments, family occasions, medications; and 10) traveling out of the neighborhood]. Performance in each category is rated from 0 - 3 as follows: 0 - normal; 1 - has difficulty, but does by self; 2 - requires assistance; or 3 - dependent. The FAQ was administered by a trained interviewer. Higher scores indicate a greater requirement of assistance.

Change From Baseline Over Time in Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI) General Condition Score

The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning. Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening.

Change From Baseline Over Time in ADCS-CGIC-MCI Cognition Score

Change From Baseline Over Time in ADCS-CGIC-MCI Behavior Score

Change From Baseline Over Time in ADCS-CGIC-MCI Functional Abilities Score

The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning (functional abilities). Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening.

Change From Baseline Over Time in University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) - Total Score

The UPSA-Brief is a performance-based instrument which uses a series of tasks and roleplay scenarios to evaluate a person's functional capacity in two areas of basic living skills (i.e., financial skills and communication skills). Scores range from 0 to 100; a higher score of the UPSA-Brief is desirable.

Change From Baseline Over Time in 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients With Mild Cognitive Impairment (ADCS-MCI-ADL-24) Total Score

The ADCS-MCI-ADL-24 is a 24-item, study partner-based assessment of activities of daily living designed specifically for AD patients and is completed by a trained rater. The scale assesses functional activities such as cooking, household chores, shopping, keeping appointments, social interactions and hobbies. Items are assessed according to whether they were performed in the past 4 weeks and, if so, some items are further assessed as to whether they were performed independently, with supervision, or with physical help. Scores on the ADCS-ADL-MCI range from 0 to 69, where higher score indicates greater capability to carry out activities of daily living.

Change From Baseline Over Time in Repeatable Battery for Assessment of Neuropsychological Status (RBANS) - Total Scale Score

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. Total score can range from 40 to 160 with a higher score representing a better outcome.

Change From Baseline Over Time in RBANS - Coding Total Score

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Coding Total Score of the RBANS ranges from 0 to 89, with a higher score representing a better outcome.

Change From Baseline Over Time in RBANS - Digit Span Total Score

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Digit Span Total Score of the RBANS ranges from 0 to 8, with a higher score representing a better outcome.

Change From Baseline Over Time in RBANS - Figure Copy Total Score

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Figure Copy Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome.

Change From Baseline Over Time in RBANS - Figure Recall Total Score

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Figure Recall Total Score of the RBANS ranges from 0 to 18, with a higher score representing a better outcome.

Change From Baseline Over Time in RBANS - List Recognition Total Score

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Recognition Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome.

Change From Baseline Over Time in RBANS - List Learning Total Score

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Learning Total Score of the RBANS ranges from 0 to 40, with a higher score representing a better outcome.

Change From Baseline Over Time in RBANS - Line Orientation Total Score

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Line Orientation Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome.

Change From Baseline Over Time in RBANS - List Recall Total Score

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Recall Total Score of the RBANS ranges from 0 to 10, with a higher score representing a better outcome.

Change From Baseline Over Time in RBANS - Picture Naming Total Score

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Picture Naming Total Score of the RBANS ranges from 0 to 10, with a higher score representing a better outcome.

Change From Baseline Over Time in RBANS - Semantic Fluency Total Score

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Semantic Fluency Total Score of the RBANS ranges from 0 to 40, with a higher score representing a better outcome.

Change From Baseline Over Time in RBANS - Story Memory Total Score

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Story Memory Total Score of the RBANS ranges from 0 to 24, with a higher score representing a better outcome.

Change From Baseline Over Time in RBANS - Story Recall Total Score

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Story Recall Total Score of the RBANS ranges from 0 to 12, with a higher score representing a better outcome.

Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Total Score

The MMSE is a brief, 30-point questionnaire, administered by a trained rater, which provides a quantitative measure of cognitive status in adults and is widely used to screen for cognitive impairment and to estimate the severity of cognitive impairment at a given point in time in AD participants. The MMSE ranges from 0 to 30, with lower scores indicating greater impairment.

Change From Baseline Over Time in Neuropsychiatry Inventory (NPI) Total Score

The NPI is used to assess changes in the participant's behavior that occurred in a defined period of time (4 weeks). The NPI assesses 12 behavioral domains on the dimensions of frequency and severity. Frequency is rated on a scale where 0 = absent, 1 = occasionally, 2 = often, 3 = frequently, 4 = very frequently. Severity is rated on a scale where 0 = absent, 1 = mild, 2 = moderate, 3 = severe. For each of the domains, 3 scores are obtained: frequency, severity, and total (product of frequency and severity; ranges from 0 to 12, with a lower score desirable). A total NPI score can be calculated by summing the domain total scores. Total Score ranges from 0 to 144 with a lower score desirable.

Change From Baseline Over Time in Alzheimer's Disease Composite Score (ADCOMS) Score

ADCOMS score is a composite score which is a weighted linear combination of the selected individual scale items from ADAS-Cog-14 (see description in Outcome Measure 10) , MMSE (see description in Outcome Measure 45), and CDR-SB (see description in Outcome Measure 1) scales. The ADCOMS score ranges from 0 to 1.97, with a lower score desirable.

Full Information

NCT ID

NCT02880956

First Posted

August 24, 2016

Last Updated

August 4, 2022

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02880956

Brief Title

A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease

Official Title

A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

January 26, 2017 (Actual)

Primary Completion Date

March 30, 2021 (Actual)

Study Completion Date

July 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study seeks to evaluate the efficacy and safety of ABBV-8E12 in participants with early Alzheimer's disease (AD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

Early Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI), Mild Alzheimer's Disease (AD), Tau, Early dementia, Tauopathies, AD, Neurodegenerative diseases, Memory loss, Nervous system diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

453 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo for ABBV-8E12 every 4 weeks for 96 weeks

Arm Title

ABBV-8E12 300 mg

Arm Type

Experimental

Arm Description

ABBV-8E12 300 mg every 4 weeks for 96 weeks

Arm Title

ABBV-8E12 1000 mg

Arm Type

Experimental

Arm Description

ABBV-8E12 1000 mg every 4 weeks for 96 weeks

Arm Title

ABBV-8E12 2000 mg

Arm Type

Experimental

Arm Description

ABBV-8E12 2000 mg every 4 weeks for 96 weeks

Intervention Type

Drug

Intervention Name(s)

ABBV-8E12

Other Intervention Name(s)

Tilavonemab

Intervention Description

ABBV-8E12 solution for IV infusion

Intervention Type

Drug

Intervention Name(s)

placebo for ABBV-8E12

Intervention Description

placebo solution for intravenous (IV) infusion

Primary Outcome Measure Information:

Title

Change From Baseline Over Time in CDR-SB Score

Description

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Description

Time Frame

From first dose of study drug up to last dose of study drug plus 20 weeks (up to Week 112)

Secondary Outcome Measure Information:

Title

Maximum Observed Serum Concentration (Cmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Time Frame

Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.

Title

Time to Cmax (Tmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Time Frame

Title

Serum Concentration at the End of a Dose Interval (Ctrough) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Time Frame

Title

Half-Life (T1/2) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Description

Harmonic mean is presented in the data table.

Time Frame

Title

Area Under the Concentration-Time Curve From Dosing (Time 0) to Day 28 (AUC0-28) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Description

Time Frame

Day 1 (Dose 1): pre-infusion, up to Day 29 (trough level before Dose 2). Day 85 (Dose 4): pre-infusion, up to Day 113 (trough level before Dose 5). See Outcome Measure description above for complete time point details.

Title

Cmax/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Time Frame

Title

AUC0-28/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Description

Time Frame

Title

Change From Baseline Over Time in Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) Total Score

Description

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in ADAS-Cog-14 Comprehension of Spoken Language Score

Description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Comprehension of Spoken Language score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in ADAS-Cog-14 Constructional Praxis Score

Description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Constructional Praxis Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in ADAS-Cog-14 Commands Score

Description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Commands Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in ADAS-Cog-14 Delayed Word Recall Score

Description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Delayed Word Recall Score of the ADAS-Cog-14 ranges from 0 to 10, with a higher score representing greater impairment.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in ADAS-Cog-14 Ideational Praxis Score

Description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Ideational Praxis Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in ADAS-Cog-14 Maze Task Score

Description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Maze Task Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in ADAS-Cog-14 Number Cancellation Score

Description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Number Cancellation Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in ADAS-Cog-14 Naming Score

Description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Naming Score of the ADAS-Cog-14 ranges from 0 to 5 with a higher score representing greater impairment.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in ADAS-Cog-14 Orientation Score

Description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Orientation Score of the ADAS-Cog-14 ranges from 0 to 8, with a higher score representing greater impairment.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in ADAS-Cog-14 Word Recall - Number of Words Not Recalled Score

Description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Recall - Number of Words Not Recalled Score of the ADAS-Cog-14 ranges from 0 to 10, with a higher score representing greater impairment.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in ADAS-Cog-14 Remember Word Recognition Instructions Score

Description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Remember Word Recognition Instructions Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in ADAS-Cog-14 Spoken Language Ability Score

Description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Spoken Language Ability Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in ADAS-Cog-14 Word Find Difficulty Spontaneous Speech Score

Description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Find Difficulty Spontaneous Speech Score of the ADAS-Cog-14 ranges from 0 to 5, with a higher score representing greater impairment.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in ADAS-Cog-14 Word Recognition Score

Description

The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in MCI patients. The Word Recognition Score of the ADAS-Cog-14 ranges from 0 to 12, with a higher score representing greater impairment.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in Functional Activities Questionnaire (FAQ) Score

Description

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI) General Condition Score

Description

Time Frame

Baseline, Week 48, Week 96

Title

Change From Baseline Over Time in ADCS-CGIC-MCI Cognition Score

Description

Time Frame

Baseline, Week 48, Week 96

Title

Change From Baseline Over Time in ADCS-CGIC-MCI Behavior Score

Description

Time Frame

Baseline, Week 48, Week 96

Title

Change From Baseline Over Time in ADCS-CGIC-MCI Functional Abilities Score

Description

The instrument assesses the physician's global impression of change in 4 major cognitive domains. The instrument covers 4 major domains: 1. General condition , 2. Cognition, 3. Behavior, and 4. Social and daily functioning (functional abilities). Scoring is based on a 7-point Likert Scale: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Higher score indicates greater worsening.

Time Frame

Baseline, Week 48, Week 96

Title

Change From Baseline Over Time in University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) - Total Score

Description

Time Frame

Baseline, Week 48, Week 96

Title

Change From Baseline Over Time in 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients With Mild Cognitive Impairment (ADCS-MCI-ADL-24) Total Score

Description

Time Frame

Baseline, Week 48, Week 96

Title

Change From Baseline Over Time in Repeatable Battery for Assessment of Neuropsychological Status (RBANS) - Total Scale Score

Description

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in RBANS - Coding Total Score

Description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Coding Total Score of the RBANS ranges from 0 to 89, with a higher score representing a better outcome.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in RBANS - Digit Span Total Score

Description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Digit Span Total Score of the RBANS ranges from 0 to 8, with a higher score representing a better outcome.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in RBANS - Figure Copy Total Score

Description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Figure Copy Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in RBANS - Figure Recall Total Score

Description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Figure Recall Total Score of the RBANS ranges from 0 to 18, with a higher score representing a better outcome.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in RBANS - List Recognition Total Score

Description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Recognition Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in RBANS - List Learning Total Score

Description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Learning Total Score of the RBANS ranges from 0 to 40, with a higher score representing a better outcome.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in RBANS - Line Orientation Total Score

Description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Line Orientation Total Score of the RBANS ranges from 0 to 20, with a higher score representing a better outcome.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in RBANS - List Recall Total Score

Description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The List Recall Total Score of the RBANS ranges from 0 to 10, with a higher score representing a better outcome.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in RBANS - Picture Naming Total Score

Description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Picture Naming Total Score of the RBANS ranges from 0 to 10, with a higher score representing a better outcome.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in RBANS - Semantic Fluency Total Score

Description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Semantic Fluency Total Score of the RBANS ranges from 0 to 40, with a higher score representing a better outcome.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in RBANS - Story Memory Total Score

Description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Story Memory Total Score of the RBANS ranges from 0 to 24, with a higher score representing a better outcome.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in RBANS - Story Recall Total Score

Description

The RBANS is a 25-minute, standardized neurocognitive battery with North American population-based normative data. The RBANS measures five neurocognitive domains, with age-based scaling. Twelve subtests measure cognitive decline or improvement across the following domains: 1. Immediate Memory - List Learning and Story Memory, 2. Visuospatial/Constructional - Figure Copy and Line Orientation, 3. Language - Picture naming and Semantic Fluency, 4. Attention - Digit Span and Coding, and 5. Delayed Memory - List Recall, List Recognition, Story Memory, and Figure Recall. The Story Recall Total Score of the RBANS ranges from 0 to 12, with a higher score representing a better outcome.

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Total Score

Description

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in Neuropsychiatry Inventory (NPI) Total Score

Description

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

Title

Change From Baseline Over Time in Alzheimer's Disease Composite Score (ADCOMS) Score

Description

Time Frame

Baseline, Week 24, Week 48, Week 72, Week 96

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject who meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have: Clinical Dementia Rating (CDR)-Global Score of 0.5 Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory Index (RBANS - DMI) score of 85 or lower Subject has a positive amyloid positron emission tomography (PET) scan. Subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4. The subject has an identified, reliable, study partner (e.g., family member). If using medications to treat symptoms related to AD, doses must be stable for at least 12 weeks prior to randomization. Exclusion Criteria: Subject has any contraindications or inability to tolerate brain magnetic resonance imaging (MRI), PET scans or lumbar puncture. Subject has evidence of any other clinically significant neurological disorder other than early AD. In the opinion of the investigator, the subject has any clinically significant or uncontrolled medical or psychiatric illness, or has had an infection requiring medical intervention in the past 30 days. Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of Screening.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ABBVIE INC.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Banner University of Arizona Medical Center Phoenix /ID# 151536

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

Banner Sun Health Res Inst /ID# 151895

City

Sun City

State/Province

Arizona

ZIP/Postal Code

85351

Country

United States

Facility Name

Irvine Clinical Research /ID# 162331

City

Irvine

State/Province

California

ZIP/Postal Code

92614

Country

United States

Facility Name

Ucsd /Id# 152467

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Ray Dolby Brain Health Center /ID# 154965

City

San Francisco

State/Province

California

ZIP/Postal Code

94113

Country

United States

Facility Name

Univ California, San Francisco /ID# 152053

City

San Francisco

State/Province

California

ZIP/Postal Code

94143-2204

Country

United States

Facility Name

Brain Matters Research /ID# 147796

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33445

Country

United States

Facility Name

Neuropsychiatric Research Center of Southwest Florida /ID# 162332

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33912

Country

United States

Facility Name

Mayo Clinic /ID# 151236

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Synexus Clinical Research US, Inc. /ID# 147804

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806-1044

Country

United States

Facility Name

University of South Florida /ID# 151890

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Synexus Clinical Research US, Inc /ID# 151633

City

The Villages

State/Province

Florida

ZIP/Postal Code

32162-7116

Country

United States

Facility Name

Emory Midtown Infectious Disease Clinic /ID# 151492

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Atlanta Center for Medical Research /ID# 151550

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

NeuroStudies.net, LLC /ID# 152746

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30030

Country

United States

Facility Name

Great Lakes Clinical Trials /ID# 152754

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60640

Country

United States

Facility Name

Advocate Lutheran General Hospital /ID# 152052

City

Park Ridge

State/Province

Illinois

ZIP/Postal Code

60068

Country

United States

Facility Name

Southern IL Univ School of Med /ID# 151769

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62702

Country

United States

Facility Name

Indiana University /ID# 151861

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

University of Kansas Medical Center - Alzheimer's Disease Center /ID# 151554

City

Fairway

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Facility Name

University of Kentucky Chandler Medical Center /ID# 152753

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

Johns Hopkins Bayview Med Cnt /ID# 151893

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Facility Name

Massachusetts General Hospital /ID# 151770

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Brigham and Women's Physicians /ID# 151882

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Hattiesburg Clinic /ID# 202388

City

Hattiesburg

State/Province

Mississippi

ZIP/Postal Code

39401

Country

United States

Facility Name

Princeton Medical Institute /ID# 152934

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

Facility Name

Scott Research Inc. /ID# 151880

City

Laurelton

State/Province

New York

ZIP/Postal Code

11413

Country

United States

Facility Name

North Shore University Hospital /ID# 151632

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11040

Country

United States

Facility Name

Duke Cancer Center /ID# 147828

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710-3000

Country

United States

Facility Name

Oregon Health and Science University /ID# 151690

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Keystone Clinical Studies LLC /ID# 202305

City

Plymouth Meeting

State/Province

Pennsylvania

ZIP/Postal Code

19462

Country

United States

Facility Name

Rhode Island Hospital /ID# 151538

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Vanderbilt University Medical Center /ID# 154547

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-0011

Country

United States

Facility Name

Kerwin Research Center /ID# 147815

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231-4316

Country

United States

Facility Name

Houston Methodist Hospital /ID# 154810

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

McGovern Medical School /ID# 204860

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

Country

United States

Facility Name

University of Utah /ID# 151858

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112-5500

Country

United States

Facility Name

Integrated Neurology Services /ID# 154863

City

Alexandria

State/Province

Virginia

ZIP/Postal Code

22310

Country

United States

Facility Name

The Kinghorn Cancer Centre /ID# 152632

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Griffith University /ID# 152635

City

Southport

State/Province

Queensland

ZIP/Postal Code

4222

Country

Australia

Facility Name

Austin Health /ID# 152637

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

The Royal Melbourne Hospital /ID# 202633

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Australian Alzheimer's Res Fou /ID# 152634

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Neurodegenerative Disorders Research /ID# 152826

City

West Perth

State/Province

Western Australia

ZIP/Postal Code

6005

Country

Australia

Facility Name

UCL Saint-Luc /ID# 152847

City

Woluwe-Saint-Lambert

State/Province

Bruxelles-Capitale

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Universitair Ziekenhuis Leuven /ID# 152642

City

Leuven

State/Province

Vlaams-Brabant

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Groupe Sante CHC - Clinique du MontLegia /ID# 152846

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Parkwood Institute /ID# 164204

City

London

State/Province

Ontario

ZIP/Postal Code

N6C 0A7

Country

Canada

Facility Name

Toronto Memory Program /ID# 147863

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3B 2S7

Country

Canada

Facility Name

Rigshospitalet /ID# 153192

City

Copenhagen Ø

State/Province

Hovedstaden

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Clinical Research Services Turku /ID# 152845

City

Turku

State/Province

Varsinais-Suomi

ZIP/Postal Code

20520

Country

Finland

Facility Name

Ita-Suomen Yliopisto /ID# 152959

City

Kuopio

ZIP/Postal Code

70210

Country

Finland

Facility Name

AOU di Modena /ID# 152394

City

Modena

State/Province

Emilia-Romagna

ZIP/Postal Code

41126

Country

Italy

Facility Name

Policlinico Agostino Gemelli /ID# 152396

City

Rome

State/Province

Lazio

ZIP/Postal Code

00168

Country

Italy

Facility Name

Duplicate_AOU Policlinico Umberto I /ID# 163144

City

Rome

State/Province

Lazio

ZIP/Postal Code

00185

Country

Italy

Facility Name

Azienda Ospedaliera di Perugia /ID# 152397

City

Perugia

State/Province

Umbria

ZIP/Postal Code

06129

Country

Italy

Facility Name

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli /ID# 152395

City

Brescia

ZIP/Postal Code

25125

Country

Italy

Facility Name

ASST Grande Ospedale Metropolitano Niguarda /ID# 152391

City

Milano

ZIP/Postal Code

20162

Country

Italy

Facility Name

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 152401

City

Milan

ZIP/Postal Code

20122

Country

Italy

Facility Name

Universitair Medisch Centrum Utrecht /ID# 163576

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

CGM Research Trust /ID# 152827

City

Burwood

ZIP/Postal Code

8083

Country

New Zealand

Facility Name

Fundacion CITA Alzheimer Fundazioa /ID# 152645

City

Donostia

State/Province

Pais Vasco

ZIP/Postal Code

20009

Country

Spain

Facility Name

Fundacio ACE /ID# 152643

City

Barcelona

ZIP/Postal Code

08028

Country

Spain

Facility Name

Hospital Clinic de Barcelona /ID# 152646

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Clinico Universitario San Carlos /ID# 153703

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre /ID# 152647

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Karolinska University Hospital Huddinge /ID# 156705

City

Stockholm

State/Province

Stockholms Lan

ZIP/Postal Code

171 77

Country

Sweden

Facility Name

Sahlgrenska University Hospital Molndal /ID# 154465

City

Molndal

State/Province

Vastra Gotalands Lan

ZIP/Postal Code

431 80

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing, please refer to the link below.

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing URL

https://vivli.org/ourmember/abbvie/

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease

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