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A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Participants With Early Alzheimer's Disease (MissionAD1)

Primary Purpose

Alzheimer's Disease

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Elenbecestat

Placebo

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Elenbecestat, E2609, Alzheimer's Disease, Early Alzheimer's Disease, Prodromal Alzheimer's Disease, Dementia, Dementia, Alzheimer's type, Mild Cognitive Impairment, MissionAD1

Eligibility Criteria

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

Inclusion Criteria:

Core Study

Mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia including
1. Mini Mental State Examination score equal to or greater than 24
2. Clinical Dementia Rating (CDR) global score of 0.5
3. CDR Memory Box score of 0.5 or greater
Impaired episodic memory confirmed by a list learning task
Positive biomarker for brain amyloid pathology as indicated by either amyloid positron emission tomography or cerebrospinal fluid AD assessment or both

Extension Phase

• Participants who complete the Core Study

Exclusion Criteria:

Core Study

Females who are breastfeeding or pregnant at Screening or Baseline. Females of child-bearing potential must use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation
Any condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD
Participants with a history of seizures within 5 years of Screening
History of transient ischemic attacks or stroke within 12 months of Screening
Psychiatric diagnosis or symptoms (example, hallucinations, major depression, delusions etc.)
Suicidal ideation or any suicidal behavior within 6 months before Screening or has been hospitalized or treated for suicidal behavior in the past 5 years
Have any contraindications to magnetic resonance imaging (MRI) scanning or
1. Have lesions that could indicate a dementia diagnosis other than AD on brain MRI
2. Exhibit other significant pathological findings on brain MRI.
Participants who have a history of moderate to severe hepatic impairment (example, Child-Pugh Class B or C)
Results of laboratory tests conducted during Screening that are outside the following limits:
1. Absolute lymphocyte count below the lower limit of normal (LLN)
2. Thyroid stimulating hormone above normal range
3. Abnormally low Vitamin B12 levels
Participants at increased risk of infection
Have received any live vaccine/live attenuated vaccine in the 3 months before randomization
Any chronic inflammatory disease that is not adequately controlled or that requires systemic immunosuppressive or immunomodulatory therapy
Any other clinically significant abnormalities
Severe visual or hearing impairment
A prolonged corrected QT (QTc) interval (QT interval with Fridericia's correction [QTcF] greater than 450 milliseconds [ms])
Malignant neoplasms within 5 years of Screening
Known or suspected history of drug or alcohol abuse
Taking prohibited medications, which must be reviewed with the Investigator
Have participated in a recent clinical study

Note: Other protocol-defined Inclusion/Exclusion Criteria may apply.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Core Study: Elenbecestat 50 mg

Core Study: Placebo

Open-label Extension Phase: Elenbecestat 50 mg

Arm Description

Participants will receive one 50 milligram (mg) elenbecestat tablet, orally, once a day in the morning. The core study will be double blinded.

Participants will receive one matching placebo tablet, orally, once a day in the morning. The core study will be double blinded.

Participants completing the core study will receive one 50 mg elenbecestat tablet, orally, once a day in the morning.

Outcomes

Primary Outcome Measures

Core Phase: Change From Baseline up to Month 24 in the Clinical Dementia Rating-sum of Boxes (CDR-SB) Score

The clinical dementia rating (CDR) scale is a clinical global rating scale that requires interviewing both the participant and an informant who knows and has contact with the participant. The CDR scale is a clinician directed assessment of both cognition and function, and is intended to capture the state and therefore the disease stage of the participant. The CDR scale assesses 6 domains of participant function (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 and severe impairment=3. The CDR-SB is a sum of the individual domain scores and ranges from 0 to 18. Higher score indicates more impairment.

Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

A TEAE is defined as an adverse event that emerged during treatment or within 28 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the adverse event was continuous. Number of participants with TEAEs (serious and non-serious adverse events) were reported based on their safety assessments of laboratory tests, suicidal ideation and suicidal behavior, drug abuse potential, physical examination, neurological examination, regular measurement of vital signs, magnetic resonance imaging and electrocardiogram parameter values.

Secondary Outcome Measures

Core Phase: Change From Baseline up to Month 24 in Alzheimer's Disease Composite Score (ADCOMS)

ADCOMS is a weighted linear combination of 12 items from three existing clinical scales: the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), the Mini Mental State Examination (MMSE), and the CDR. Four items are from the ADAS-cog (A4 [Delayed Word Recall], A7 [Orientation], A8 [Word Recognition], A11 [Word Finding]); 2 items are from the MMSE (M1 [Orientation Time], M7 [Drawing]); 6 items are from the CDR (C1 [Personal Care], C2 [Community Affairs], C3 [Home and Hobbies], C4 [Judgment and Problem Solving], C5 [Memory], C6 [Orientation]). Composite score is derived from the variables from the 12 items, and ranges from 0 to 1.97, where higher score indicates worse performance.

Core Phase: Change From Baseline up to Month 24 in Amyloid Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR)

Amyloid PET scan assesses cerebral amyloid load using 3 tracers (florbetapir, florbetaben and flutemetamol) which is standardized into centiloids for evaluation of AD. Centiloid values on centiloid scale is based on mean composite SUVR in cingulate, frontal, parietal and temporal cortexes using whole cerebellum as reference region. SUVR is ratio of tracer uptake in each of cingulate, frontal, parietal and temporal cortexes relative to cerebellum. The centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scans.

Core Phase: Change From Baseline up to Month 24 in the CDR-SB Score for Participants Enriched by Baseline Amyloid PET SUVR Between 1.2 and 1.6

The CDR scale is a clinical global rating scale that requires interviewing both the participant and an informant who knows and has contact with the participant. The CDR scale is a clinician directed assessment of both cognition and function, and is intended to capture the state and therefore the disease stage of the participant. The CDR scale assesses 6 domains of participant function (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 and severe impairment=3. The CDR-SB is a sum of the individual domain scores and ranges from 0 to 18. Higher score indicates more impairment. Amyloid PET scans allow in vivo assessment of cerebral amyloid load. SUVR indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum.

Core Phase: Change From Baseline up to Month 24 in the ADCOMS for Participants Enriched by Baseline Amyloid PET SUVR Between 1.2 and 1.6

ADCOMS is a weighted linear combination of 12 items from three existing clinical scales: the ADAS-cog, the MMSE, and the CDR. Four items are from the ADAS-cog (A4 [Delayed Word Recall], A7 [Orientation], A8 [Word Recognition], A11 [Word Finding]); 2 items are from the MMSE (M1 [Orientation Time], M7 [Drawing]); 6 items are from the CDR (C1 [Personal Care], C2 [Community Affairs], C3 [Home and Hobbies], C4 [Judgment and Problem Solving], C5 [Memory], C6 [Orientation]). Composite score is derived from the variables from the 12 items, and ranges from 0 to 1.97, where higher score indicates worse performance. Amyloid PET scans allow in vivo assessment of cerebral amyloid load. SUVR indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum.

Core Phase: Change Per Year (Mean Slope) in CDR-SB Score up to Month 24

The CDR scale is a clinical global rating scale that requires interviewing both the participant and an informant who knows and has contact with the participant. The CDR scale is a clinician directed assessment of both cognition and function, and is intended to capture the state and therefore the disease stage of the participant. The CDR scale assesses 6 domains of participant function (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 and severe impairment=3. The CDR-SB is a sum of the individual domain scores and ranges from 0 to 18. Higher score indicates more impairment. In this outcome measure, change per year (mean slope) in CDR-SB score was calculated up to month 24, where higher change indicated more impairment and lower change indicated less impairment.

Core Phase: Time to Worsening of CDR Score up to Month 24

The CDR scale is a clinical global rating scale that requires interviewing both the participant and an informant who knows and has contact with the participant. The CDR scale is a clinician directed assessment of both cognition and function, and is intended to capture the state and therefore the disease stage of the participant. The CDR scale assesses 6 domains of participant function (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 and severe impairment=3. The global CDR score is computed via an algorithm and ranges from 0 to 3. Higher score indicates more impairment. In this outcome measure, time (in months) to worsening of CDR score (that is, an increase from baseline by at least 0.5 points on the global CDR scale on 2 consecutive scheduled visits) up to month 24 was calculated.

Core Phase: Time to Conversion to Dementia for Participants Who Were Not Clinically Staged as Having Dementia at the Core Phase Baseline up to Month 24

Time (in months) to conversion to dementia for participants who were not clinically staged as having dementia at the core phase baseline (that is time from randomization to conversion to dementia in clinical diagnosis).

Core Phase: Change From Baseline up to Month 24 in the Alzheimer's Disease Assessment Scale-cognition14 (ADAS-Cog14) Score

ADAS-cog14 is a psychometric instrument that evaluates 14-items (Immediate Word-recall [0-10], Commands [0-5], Constructional Praxis [0-5], Delayed Word-recall [0-10], Naming Objects/Fingers [0-5], Ideational Praxis [0-5], Orientation[0-8], Word Recognition [0-12], Remembering Test Instructions [0-5], Comprehension[0-5], Word Finding Difficulty [0-5], Spoken Language Ability [0-5], Executive Function [0-5], and Number Cancellation [0-5] test). It is considered to be more sensitive for less impaired populations such as MCI/Prodromal and mild AD participants. The total score ranges from 0 to 90. Higher score indicates more impairment.

Core Phase: Change From Baseline up to Month 24 in the MMSE Score

The MMSE is a cognitive instrument commonly used for screening purposes, for staging of disease severity and is often measured longitudinally in AD clinical studies to follow disease progression and treatment effects. MMSE is composed of 30 questions grouped into domains (Orientation to Time [0-5], Orientation to Place [0-5], Registration [0-3], Attention and Calculation [0-5], Recall [0-3], Naming [0-2], Repetition [0-1], Comprehension [0-3], Reading [0-1], Writing [0-1], Drawing [0-1]). For each of the MMSE domains, six items are computed (Orientation to Time [0-5], Orientation to Place [0-5], Registration [0-3], Attention and Calculation [0-5], Recall [0-3], Language: Naming, Repetition, Comprehension, Reading, Writing, and Drawing [0-9]). The MMSE Total Score is the sum of the six domains and ranges from 0 to 30. If any domain score was missing then the total score was missing. Higher score indicates better function.

Core Phase: Change From Baseline up to Month 24 in the Functional Assessment Questionnaire (FAQ) Score

FAQ scores 10 items & measures activities of daily living (paying bills/balancing checkbook, assembling tax records, shopping alone for clothes or groceries, playing game of skill such as bridge or chess/working on a hobby, heating water & turning off stove, preparing balanced meal, keeping track of current events, paying attention & understanding television program, remembering appointments, driving or traveling out of neighborhood). Each item is rated as follows: 0=Normal, 1=Has difficulty but does by self, 2=Requires assistance, 3=Dependent, or 8=Not Applicable. The total score is the sum of all 10 items & ranges from 0 to 30. Higher score indicates more impairment. If any activity was missed, then the total score was missed. Activities rated as "Not Applicable" were not used in the computation of the total score. To account for "Not Applicable" activity, the total score was weighted as:Total Score=Total Score*30/(30 minus 3 times the number of activities marked"Not Applicable").

Core Phase: Change From Baseline up to Month 24 in the ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score

The ADAS-cog14 Word List is a summation of two items: "Immediate Word-recall" and "Delayed Word-recall". Immediate Word-recall test: Participants are asked to recall words and the number of "No" responses for each trial (total 3 trials) are summed. Subscore: sum of scores from 3 trials, divided by 3. Score ranges from 0 to 10. Delayed Word-recall: Participants used to recall words after a delay and the number of "No" responses are summed. Score ranges from 0 to 10. The Total Score ranges from 0 to 20. Higher score indicates more impairment.

Core Phase: Change From Baseline up to Month 24 in the Alzheimer's Disease Assessment Scale-cognition11 (ADAS-Cog11) Score

ADAS-cog11 is a psychometric instrument that evaluates 11-items (Immediate Word-recall [0 to 10], Commands [0-5], Constructional Praxis [0-5], Naming Objects/Fingers [0-5], Ideational Praxis [0-5], Orientation[0-8], Word Recognition [0-12], Remembering Test Instructions [0-5], Comprehension[0-5], Word Finding Difficulty [0-5], Spoken Language Ability [0-5] test) and is considered more sensitive for less impaired populations such as MCI/Prodromal and mild AD participants. The Total score ranges from 0 to 70. Higher score indicates more impairment.

Core Phase: Change From Last Dose in the CDR-SB Score

Core Phase: Change From Last Dose in the ADCOMS

Core Phase: Change From Last Dose in the ADAS-cog11 Score

Core Phase: Change From Last Dose in the ADAS-cog14 Score

ADAS-cog14 is a psychometric instrument that evaluates 14-items (Immediate Word-recall [0 to 10], Commands [0-5], Constructional Praxis [0-5], Delayed Word-recall [0-10], Naming Objects/Fingers [0-5], Ideational Praxis [0-5], Orientation[0-8], Word Recognition [0-12], Remembering Test Instructions [0-5], Comprehension[0-5], Word Finding Difficulty [0-5], Spoken Language Ability [0-5], Executive Function [0-5], and Number Cancellation [0-5] test). It is considered to be more sensitive for less impaired populations such as MCI/Prodromal and mild AD participants. The Total Score ranges from 0 to 90. Higher score indicates more impairment.

Core Phase: Change From Last Dose in the MMSE Score

Core Phase: Change From Last Dose in the ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in CDR-SB Score

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADCOMS

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in MMSE Score

The MMSE is a cognitive instrument commonly used for screening purposes, for staging of disease severity and is often measured longitudinally in AD clinical studies to follow disease progression and treatment effects. MMSE is composed of 30 questions grouped into domains (Orientation to Time [0-5], Orientation to Place [0-5], Registration [0-3], Attention and Calculation [0-5], Recall [0-3], Naming [0-2], Repetition [0-1], Comprehension [0-3], Reading [0-1], Writing [0-1], Drawing [0-1]). For each of the MMSE domains, six items are computed (Orientation to Time [0-5], Orientation to Place [0-5], Registration [0-3], Attention and Calculation [0-5], Recall [0-3], Language: Naming, Repetition, Comprehension, Reading, Writing, and Drawing [0-9]). The MMSE Total Score is the sum of the six domains and ranges from 0 to 30. If any domain score is missing then the total score is missing. Higher score indicates better function.

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in FAQ Score

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADAS-cog14 Score

ADAS-cog14 is a psychometric instrument that evaluates 14-items (Immediate Word-recall [0 to 10], Commands [0-5], Constructional Praxis [0-5], Delayed Word-recall [0-10], Naming Objects/Fingers [0-5], Ideational Praxis [0-5], Orientation[0-8], Word Recognition [0-12], Remembering Test Instructions [0-5], Comprehension[0-5], Word Finding Difficulty [0-5], Spoken Language Ability [0-5], Executive Function [0-5], and Number Cancellation [0-5] test). It is considered to be more sensitive for less impaired populations such as MCI/Prodromal and mild AD participants. The total score ranges from 0 to 90. Higher score indicates more impairment.

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score

Extension Phase: Time to Conversion to Dementia for Participants Who Were Not Clinically Staged as Having Dementia at the Core Phase Baseline up to Month 12 of the Extension Phase

Full Information

NCT ID

NCT02956486

First Posted

November 3, 2016

Last Updated

January 14, 2021

Sponsor

Eisai Co., Ltd.

Collaborators

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT02956486

Brief Title

A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Participants With Early Alzheimer's Disease

Acronym

MissionAD1

Official Title

A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study With an Open-Label Extension Phase to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Terminated

Why Stopped

Due to an unfavorable risk-benefit ratio including no evidence of potential efficacy, and the adverse event profile of E2609 being worse than placebo.

Study Start Date

October 20, 2016 (Actual)

Primary Completion Date

January 15, 2020 (Actual)

Study Completion Date

January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eisai Co., Ltd.

Collaborators

Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The name of this trial is MissionAD1. This phase 3 study consists of a Core and Open Label Extension (OLE) Phase in participants with Early Alzheimer's Disease (EAD), and will be conducted to evaluate the efficacy and safety of E2609. The Core is a 24-month treatment, multicenter, double blind, placebo controlled parallel group study. The OLE is a 24-month treatment, one group study. The data for the studies E2609-G000-301 (NCT02956486, MissionAD1) and E2609-G000-302 (NCT03036280, MissionAD2) will be pooled.

6. Conditions and Keywords

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

Alzheimer's Disease

Keywords

Elenbecestat, E2609, Alzheimer's Disease, Early Alzheimer's Disease, Prodromal Alzheimer's Disease, Dementia, Dementia, Alzheimer's type, Mild Cognitive Impairment, MissionAD1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2212 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Core Study: Elenbecestat 50 mg

Arm Type

Experimental

Arm Description

Participants will receive one 50 milligram (mg) elenbecestat tablet, orally, once a day in the morning. The core study will be double blinded.

Arm Title

Core Study: Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive one matching placebo tablet, orally, once a day in the morning. The core study will be double blinded.

Arm Title

Open-label Extension Phase: Elenbecestat 50 mg

Arm Type

Experimental

Arm Description

Participants completing the core study will receive one 50 mg elenbecestat tablet, orally, once a day in the morning.

Intervention Type

Drug

Intervention Name(s)

Elenbecestat

Other Intervention Name(s)

E2609

Intervention Description

Oral tablet.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral tablet.

Primary Outcome Measure Information:

Title

Core Phase: Change From Baseline up to Month 24 in the Clinical Dementia Rating-sum of Boxes (CDR-SB) Score

Description

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Title

Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

Description

Time Frame

From first dose of study drug up to approximately 6 months (including 1 month follow up) for the extension phase

Secondary Outcome Measure Information:

Title

Core Phase: Change From Baseline up to Month 24 in Alzheimer's Disease Composite Score (ADCOMS)

Description

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Title

Core Phase: Change From Baseline up to Month 24 in Amyloid Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR)

Description

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Title

Core Phase: Change From Baseline up to Month 24 in the CDR-SB Score for Participants Enriched by Baseline Amyloid PET SUVR Between 1.2 and 1.6

Description

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Title

Core Phase: Change From Baseline up to Month 24 in the ADCOMS for Participants Enriched by Baseline Amyloid PET SUVR Between 1.2 and 1.6

Description

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Title

Core Phase: Change Per Year (Mean Slope) in CDR-SB Score up to Month 24

Description

The CDR scale is a clinical global rating scale that requires interviewing both the participant and an informant who knows and has contact with the participant. The CDR scale is a clinician directed assessment of both cognition and function, and is intended to capture the state and therefore the disease stage of the participant. The CDR scale assesses 6 domains of participant function (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 and severe impairment=3. The CDR-SB is a sum of the individual domain scores and ranges from 0 to 18. Higher score indicates more impairment. In this outcome measure, change per year (mean slope) in CDR-SB score was calculated up to month 24, where higher change indicated more impairment and lower change indicated less impairment.

Time Frame

Up to Month 24 of the core phase

Title

Core Phase: Time to Worsening of CDR Score up to Month 24

Description

The CDR scale is a clinical global rating scale that requires interviewing both the participant and an informant who knows and has contact with the participant. The CDR scale is a clinician directed assessment of both cognition and function, and is intended to capture the state and therefore the disease stage of the participant. The CDR scale assesses 6 domains of participant function (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment=0, questionable impairment=0.5, mild impairment=1, moderate impairment=2 and severe impairment=3. The global CDR score is computed via an algorithm and ranges from 0 to 3. Higher score indicates more impairment. In this outcome measure, time (in months) to worsening of CDR score (that is, an increase from baseline by at least 0.5 points on the global CDR scale on 2 consecutive scheduled visits) up to month 24 was calculated.

Time Frame

Up to Month 24 of the core phase

Title

Core Phase: Time to Conversion to Dementia for Participants Who Were Not Clinically Staged as Having Dementia at the Core Phase Baseline up to Month 24

Description

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Title

Core Phase: Change From Baseline up to Month 24 in the Alzheimer's Disease Assessment Scale-cognition14 (ADAS-Cog14) Score

Description

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Title

Core Phase: Change From Baseline up to Month 24 in the MMSE Score

Description

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Title

Core Phase: Change From Baseline up to Month 24 in the Functional Assessment Questionnaire (FAQ) Score

Description

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Title

Core Phase: Change From Baseline up to Month 24 in the ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score

Description

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Title

Core Phase: Change From Baseline up to Month 24 in the Alzheimer's Disease Assessment Scale-cognition11 (ADAS-Cog11) Score

Description

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase

Title

Core Phase: Change From Last Dose in the CDR-SB Score

Description

Time Frame

From last dose in the core phase (up to Month 24) up to 3 months follow up (up to Month 27)

Title

Core Phase: Change From Last Dose in the ADCOMS

Description

Time Frame

From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)

Title

Core Phase: Change From Last Dose in the ADAS-cog11 Score

Description

Time Frame

From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)

Title

Core Phase: Change From Last Dose in the ADAS-cog14 Score

Description

Time Frame

From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)

Title

Core Phase: Change From Last Dose in the MMSE Score

Description

Time Frame

From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)

Title

Core Phase: Change From Last Dose in the ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score

Description

Time Frame

From last dose in the core phase (up to Month 24) up to 3 months follow-up (up to Month 27)

Title

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in CDR-SB Score

Description

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

Title

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADCOMS

Description

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

Title

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in MMSE Score

Description

The MMSE is a cognitive instrument commonly used for screening purposes, for staging of disease severity and is often measured longitudinally in AD clinical studies to follow disease progression and treatment effects. MMSE is composed of 30 questions grouped into domains (Orientation to Time [0-5], Orientation to Place [0-5], Registration [0-3], Attention and Calculation [0-5], Recall [0-3], Naming [0-2], Repetition [0-1], Comprehension [0-3], Reading [0-1], Writing [0-1], Drawing [0-1]). For each of the MMSE domains, six items are computed (Orientation to Time [0-5], Orientation to Place [0-5], Registration [0-3], Attention and Calculation [0-5], Recall [0-3], Language: Naming, Repetition, Comprehension, Reading, Writing, and Drawing [0-9]). The MMSE Total Score is the sum of the six domains and ranges from 0 to 30. If any domain score is missing then the total score is missing. Higher score indicates better function.

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

Title

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in FAQ Score

Description

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

Title

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADAS-cog14 Score

Description

ADAS-cog14 is a psychometric instrument that evaluates 14-items (Immediate Word-recall [0 to 10], Commands [0-5], Constructional Praxis [0-5], Delayed Word-recall [0-10], Naming Objects/Fingers [0-5], Ideational Praxis [0-5], Orientation[0-8], Word Recognition [0-12], Remembering Test Instructions [0-5], Comprehension[0-5], Word Finding Difficulty [0-5], Spoken Language Ability [0-5], Executive Function [0-5], and Number Cancellation [0-5] test). It is considered to be more sensitive for less impaired populations such as MCI/Prodromal and mild AD participants. The total score ranges from 0 to 90. Higher score indicates more impairment.

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

Title

Extension Phase: Change From Core Phase Baseline up to Month 12 of the Extension Phase in ADAS-cog14 Word List (Immediate Recall and Delayed Recall) Score

Description

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

Title

Extension Phase: Time to Conversion to Dementia for Participants Who Were Not Clinically Staged as Having Dementia at the Core Phase Baseline up to Month 12 of the Extension Phase

Description

Time Frame

Baseline (Day 1: before first dose in the core phase) up to Month 12 of the extension phase

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Core Study Mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia including Mini Mental State Examination score equal to or greater than 24 Clinical Dementia Rating (CDR) global score of 0.5 CDR Memory Box score of 0.5 or greater Impaired episodic memory confirmed by a list learning task Positive biomarker for brain amyloid pathology as indicated by either amyloid positron emission tomography or cerebrospinal fluid AD assessment or both Extension Phase • Participants who complete the Core Study Exclusion Criteria: Core Study Females who are breastfeeding or pregnant at Screening or Baseline. Females of child-bearing potential must use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation Any condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD Participants with a history of seizures within 5 years of Screening History of transient ischemic attacks or stroke within 12 months of Screening Psychiatric diagnosis or symptoms (example, hallucinations, major depression, delusions etc.) Suicidal ideation or any suicidal behavior within 6 months before Screening or has been hospitalized or treated for suicidal behavior in the past 5 years Have any contraindications to magnetic resonance imaging (MRI) scanning or Have lesions that could indicate a dementia diagnosis other than AD on brain MRI Exhibit other significant pathological findings on brain MRI. Participants who have a history of moderate to severe hepatic impairment (example, Child-Pugh Class B or C) Results of laboratory tests conducted during Screening that are outside the following limits: Absolute lymphocyte count below the lower limit of normal (LLN) Thyroid stimulating hormone above normal range Abnormally low Vitamin B12 levels Participants at increased risk of infection Have received any live vaccine/live attenuated vaccine in the 3 months before randomization Any chronic inflammatory disease that is not adequately controlled or that requires systemic immunosuppressive or immunomodulatory therapy Any other clinically significant abnormalities Severe visual or hearing impairment A prolonged corrected QT (QTc) interval (QT interval with Fridericia's correction [QTcF] greater than 450 milliseconds [ms]) Malignant neoplasms within 5 years of Screening Known or suspected history of drug or alcohol abuse Taking prohibited medications, which must be reviewed with the Investigator Have participated in a recent clinical study Note: Other protocol-defined Inclusion/Exclusion Criteria may apply.

Facility Information:

Facility Name

Facility #1

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85226

Country

United States

Facility Name

Facility #1

City

Colton

State/Province

California

ZIP/Postal Code

92324

Country

United States

Facility Name

Facility #1

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92626

Country

United States

Facility Name

Facility #1

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Facility #1

City

Imperial

State/Province

California

ZIP/Postal Code

92251

Country

United States

Facility Name

Facility #1

City

Irvine

State/Province

California

ZIP/Postal Code

92618

Country

United States

Facility Name

Facility #1

City

Lemon Grove

State/Province

California

ZIP/Postal Code

91945

Country

United States

Facility Name

Facility #1

City

Oceanside

State/Province

California

ZIP/Postal Code

92054

Country

United States

Facility Name

Facility #2

City

Oceanside

State/Province

California

ZIP/Postal Code

92054

Country

United States

Facility Name

Facility #1

City

Oxnard

State/Province

California

ZIP/Postal Code

93030

Country

United States

Facility Name

Facility #1

City

Panorama City

State/Province

California

ZIP/Postal Code

91402

Country

United States

Facility Name

Facility #1

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Facility #1

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

Facility #1

City

Atlantis

State/Province

Florida

ZIP/Postal Code

33462

Country

United States

Facility Name

Facility #1

City

Aventura

State/Province

Florida

ZIP/Postal Code

33187

Country

United States

Facility Name

Facility #2

City

Aventura

State/Province

Florida

ZIP/Postal Code

33187

Country

United States

Facility Name

Facility #1

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33437

Country

United States

Facility Name

Facility #1

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Facility #2

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Facility #1

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33445

Country

United States

Facility Name

Facility #1

City

Doral

State/Province

Florida

ZIP/Postal Code

33122

Country

United States

Facility Name

Facility #1

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Facility #2

City

Miami

State/Province

Florida

ZIP/Postal Code

33122

Country

United States

Facility Name

Facility #11

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

Facility #9

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

Facility #10

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Facility #4

City

Miami

State/Province

Florida

ZIP/Postal Code

33133

Country

United States

Facility Name

Facility #1

City

Miami

State/Province

Florida

ZIP/Postal Code

33137

Country

United States

Facility Name

Facility #6

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Facility #3

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Facility #7

City

Miami

State/Province

Florida

ZIP/Postal Code

33174

Country

United States

Facility Name

Facility #8

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Facility #2

City

Orlando

State/Province

Florida

ZIP/Postal Code

32801

Country

United States

Facility Name

Facility #1

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Facility #3

City

Orlando

State/Province

Florida

ZIP/Postal Code

32807

Country

United States

Facility Name

Facility #1

City

Palm Beach Gardens

State/Province

Florida

ZIP/Postal Code

33410

Country

United States

Facility Name

Facility #1

City

Pompano Beach

State/Province

Florida

ZIP/Postal Code

33064

Country

United States

Facility Name

Facility #1

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

Country

United States

Facility Name

Facility #1

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

Facility #1

City

Spring Hill

State/Province

Florida

ZIP/Postal Code

34609

Country

United States

Facility Name

Facility #1

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Facility #2

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Facility #1

City

The Villages

State/Province

Florida

ZIP/Postal Code

32162

Country

United States

Facility Name

Facility #1

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Facility #1

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31909

Country

United States

Facility Name

Facility #1

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Facility #1

City

Suwanee

State/Province

Georgia

ZIP/Postal Code

30024

Country

United States

Facility Name

Facility #1

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Facility #1

City

Northbrook

State/Province

Illinois

ZIP/Postal Code

60062

Country

United States

Facility Name

Facility #2

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Facility #1

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

2115

Country

United States

Facility Name

Facility #1

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48334

Country

United States

Facility Name

Facility #1

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63005

Country

United States

Facility Name

Facility #1

City

O'Fallon

State/Province

Missouri

ZIP/Postal Code

63368

Country

United States

Facility Name

Facility #2

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Facility #1

City

Saint Peters

State/Province

Missouri

ZIP/Postal Code

63303

Country

United States

Facility Name

Facility #1

City

Mount Arlington

State/Province

New Jersey

ZIP/Postal Code

7856

Country

United States

Facility Name

Facility #2

City

Springfield

State/Province

New Jersey

ZIP/Postal Code

7081

Country

United States

Facility Name

Facility #1

City

West Long Branch

State/Province

New Jersey

ZIP/Postal Code

7764

Country

United States

Facility Name

Facility #1

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Facility Name

Facility #1

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11229

Country

United States

Facility Name

Facility #1

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Facility #1

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

Facility #1

City

Centerville

State/Province

Ohio

ZIP/Postal Code

45459

Country

United States

Facility Name

Facility #1

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Facility #1

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45459

Country

United States

Facility Name

Facility #1

City

Lakewood

State/Province

Ohio

ZIP/Postal Code

44107

Country

United States

Facility Name

Facility #1

City

Westerville

State/Province

Ohio

ZIP/Postal Code

43081

Country

United States

Facility Name

Facility #1

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73116

Country

United States

Facility Name

Facility #1

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Facility #1

City

Jenkintown

State/Province

Pennsylvania

ZIP/Postal Code

19046

Country

United States

Facility Name

Facility #1

City

Media

State/Province

Pennsylvania

ZIP/Postal Code

19063

Country

United States

Facility Name

Facility #1

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Facility #1

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02914

Country

United States

Facility Name

Facility #1

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

2906

Country

United States

Facility Name

Facility #1

City

Port Royal

State/Province

South Carolina

ZIP/Postal Code

29935

Country

United States

Facility Name

Facility #1

City

Cordova

State/Province

Tennessee

ZIP/Postal Code

38018

Country

United States

Facility Name

Facility #2

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Facility #1

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

Facility Name

Facility #1

City

Austin

State/Province

Texas

ZIP/Postal Code

78757

Country

United States

Facility Name

Facility #1

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Facility #1

City

Houston

State/Province

Texas

ZIP/Postal Code

77084

Country

United States

Facility Name

Facility #1

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229-3900

Country

United States

Facility Name

Facility #3

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78240

Country

United States

Facility Name

Facility #1

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84108

Country

United States

Facility Name

Facility #1

City

Bennington

State/Province

Vermont

ZIP/Postal Code

5201

Country

United States

Facility Name

Facility #1

City

Hampton

State/Province

Virginia

ZIP/Postal Code

23666

Country

United States

Facility Name

Facility #1

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

Facility Name

Facility #2

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

-1405

Country

Argentina

Facility Name

Facility #1

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1012AAR

Country

Argentina

Facility Name

Facility #4

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1126AAB

Country

Argentina

Facility Name

Facility #3

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1427

Country

Argentina

Facility Name

Facility #1

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

1111

Country

Argentina

Facility Name

Facility #3

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

1430

Country

Argentina

Facility Name

Facility #2

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1230AAZ

Country

Argentina

Facility Name

Facility #1

City

Cordoba

State/Province

Capital

ZIP/Postal Code

X5003DCE

Country

Argentina

Facility Name

Facility #1

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

2000

Country

Argentina

Facility Name

Facility #4

City

Buenos Aires

ZIP/Postal Code

1199

Country

Argentina

Facility Name

Facility #5

City

Caba

ZIP/Postal Code

C1428AQK

Country

Argentina

Facility Name

Facility #2

City

Cordoba

ZIP/Postal Code

X5004A0A

Country

Argentina

Facility Name

Facility #3

City

Cordoba

ZIP/Postal Code

X5009BIN

Country

Argentina

Facility Name

Facility #1

City

Santa Fe

ZIP/Postal Code

3000

Country

Argentina

Facility Name

Facility #1

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Facility #1

City

Macquarie Park

State/Province

New South Wales

ZIP/Postal Code

2113

Country

Australia

Facility Name

Facility #1

City

Tumbi Umbi

State/Province

New South Wales

ZIP/Postal Code

2261

Country

Australia

Facility Name

Facility #1

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4032

Country

Australia

Facility Name

Facility #1

City

Caulfield

State/Province

Victoria

ZIP/Postal Code

3162

Country

Australia

Facility Name

Facility #1

City

Geelong

State/Province

Victoria

ZIP/Postal Code

3220

Country

Australia

Facility Name

Facility #1

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Facility #1

City

Malvern

State/Province

Victoria

ZIP/Postal Code

3144

Country

Australia

Facility Name

Facility #2

City

Melbourne

State/Province

Victoria

Country

Australia

Facility Name

Facility #1

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Facility #1

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Facility #3

City

Melbourne

ZIP/Postal Code

3146

Country

Australia

Facility Name

Facility #1

City

Vienna

ZIP/Postal Code

1130

Country

Austria

Facility Name

Facility #1

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Facility #1

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Facility #1

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Facility #4

City

Sofia

ZIP/Postal Code

1142

Country

Bulgaria

Facility Name

Facility #3

City

Sofia

ZIP/Postal Code

1309

Country

Bulgaria

Facility Name

Facility #1

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Facility #2

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Facility #1

City

Kamloops

State/Province

British Columbia

ZIP/Postal Code

V2C 5T1

Country

Canada

Facility Name

Facility #1

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 1Z9

Country

Canada

Facility Name

Facility #1

City

West Vancouver

State/Province

British Columbia

ZIP/Postal Code

V7T 1C5

Country

Canada

Facility Name

Facility #1

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3S 1M7

Country

Canada

Facility Name

Facility #1

City

Kentville

State/Province

Nova Scotia

ZIP/Postal Code

B4N 4K9

Country

Canada

Facility Name

Facility #1

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1N 5C8

Country

Canada

Facility Name

Facility #1

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9H 2P4

Country

Canada

Facility Name

Facility #1

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1M 1B1

Country

Canada

Facility Name

Facility #1

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1L 0H8

Country

Canada

Facility Name

Facility #1

City

Hradec Kralove

ZIP/Postal Code

500 09

Country

Czechia

Facility Name

Facility #1

City

Kladno

ZIP/Postal Code

272 01

Country

Czechia

Facility Name

Facility #1

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Facility #1

City

Praha 10

ZIP/Postal Code

109 00

Country

Czechia

Facility Name

Facility #1

City

Montpellier

State/Province

Herault

ZIP/Postal Code

34295

Country

France

Facility Name

Facility #1

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Facility #1

City

Bron Cedex

ZIP/Postal Code

69677

Country

France

Facility Name

Facility #1

City

Marseille Cedex 05

ZIP/Postal Code

13385

Country

France

Facility Name

Facility #1

City

Nantes

ZIP/Postal Code

44800

Country

France

Facility Name

Facility #1

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Facility #1

City

Rouen

ZIP/Postal Code

76000

Country

France

Facility Name

Facility #1

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Facility #1

City

Neuburg

State/Province

Bayern

ZIP/Postal Code

86633

Country

Germany

Facility Name

Facility #1

City

Hoppegarten

State/Province

Brandenburg

ZIP/Postal Code

15366

Country

Germany

Facility Name

Facility #1

City

Oranienburg

State/Province

Brandenburg

ZIP/Postal Code

16515

Country

Germany

Facility Name

Facility #1

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60528

Country

Germany

Facility Name

Facility #1

City

Leipzig

State/Province

Saxony

ZIP/Postal Code

4107

Country

Germany

Facility Name

Facility #1

City

Berlin

ZIP/Postal Code

10245

Country

Germany

Facility Name

Facility #2

City

Berlin

ZIP/Postal Code

10629

Country

Germany

Facility Name

Facility #1

City

Gera

ZIP/Postal Code

7551

Country

Germany

Facility Name

Facility #1

City

Homburg/Saar

ZIP/Postal Code

66241

Country

Germany

Facility Name

Facility #1

City

Schwerin

ZIP/Postal Code

19053

Country

Germany

Facility Name

Facility #5

City

Athens

ZIP/Postal Code

11528

Country

Greece

Facility Name

Facility #4

City

Athens

ZIP/Postal Code

15123

Country

Greece

Facility Name

Eisai Trial Site 1

City

Anjo-shi

State/Province

Aichi

ZIP/Postal Code

446-8510

Country

Japan

Facility Name

Eisai Trial Site 1

City

Nagoya-shi

State/Province

Aichi

ZIP/Postal Code

467-8602

Country

Japan

Facility Name

Eisai Trial Site 1

City

Obu-shi

State/Province

Aichi

ZIP/Postal Code

474-8511

Country

Japan

Facility Name

Eisai Trial Site 1

City

Yoshida-gun

State/Province

Fukui

ZIP/Postal Code

910-1193

Country

Japan

Facility Name

Eisai Trail Site 1

City

Kitakyushu-shi

State/Province

Fukuoka

ZIP/Postal Code

808-0024

Country

Japan

Facility Name

Eisai Trial Site 1

City

Omuta-shi

State/Province

Fukuoka

ZIP/Postal Code

837-0911

Country

Japan

Facility Name

Eisai Trial Site 1

City

Fujioka-shi

State/Province

Gunma

ZIP/Postal Code

375-0017

Country

Japan

Facility Name

Eisai Trial Site 1

City

Otake-shi

State/Province

Hiroshima

ZIP/Postal Code

739-0651

Country

Japan

Facility Name

Eisai Trial Site 2

City

Himeji-shi

State/Province

Hyogo

ZIP/Postal Code

670-0981

Country

Japan

Facility Name

Eisai Trial Site 1

City

Himeji

State/Province

Hyogo

ZIP/Postal Code

671-1227

Country

Japan

Facility Name

Eisai Trial Site 1

City

Kobe

State/Province

Hyogo

ZIP/Postal Code

650-0017

Country

Japan

Facility Name

Facility #1

City

Miki

State/Province

Kagawa

ZIP/Postal Code

761-0793

Country

Japan

Facility Name

Eisai Trial Site 3

City

Takamatsu City

State/Province

Kagawa

ZIP/Postal Code

760-8557

Country

Japan

Facility Name

Eisai Trial Site 1

City

Fujisawa-shi

State/Province

Kanagawa

ZIP/Postal Code

251-0038

Country

Japan

Facility Name

Eisai Trial Site 4

City

Kyoto City

State/Province

Kyoto

ZIP/Postal Code

616-8255

Country

Japan

Facility Name

Eisai Trial Site 1

City

Kyoto-shi

State/Province

Kyoto

ZIP/Postal Code

602-8566

Country

Japan

Facility Name

Eisai Trial Site 2

City

Kyoto-shi

State/Province

Kyoto

ZIP/Postal Code

602-8566

Country

Japan

Facility Name

Eisai Trial site 5

City

Kyoto-shi

State/Province

Kyoto

ZIP/Postal Code

607-8113

Country

Japan

Facility Name

Eisai Trial Site 1

City

Shimogyo-ku

State/Province

Kyoto

ZIP/Postal Code

600-8558

Country

Japan

Facility Name

Eisai Trial Site 1

City

Higashimorokatagun

State/Province

Miyazaki

ZIP/Postal Code

880-1111

Country

Japan

Facility Name

Eisai Trial Site 2

City

Okayama-shi

State/Province

Okayama-ken

ZIP/Postal Code

701-1192

Country

Japan

Facility Name

Eisai Trial Site 1

City

Kurashiki-shi

State/Province

Okayama

ZIP/Postal Code

710-0813

Country

Japan

Facility Name

Eisai Trial Site 2

City

Kurashiki-shi

State/Province

Okayama

ZIP/Postal Code

710-8692

Country

Japan

Facility Name

Eisai Trial Site 1

City

Okayama-shi

State/Province

Okayama

ZIP/Postal Code

700-8557

Country

Japan

Facility Name

Eisai Trial Site 1

City

Hirakata

State/Province

Osaka

ZIP/Postal Code

573-1121

Country

Japan

Facility Name

Eisai Trial Site 1

City

Naniwa-Ku

State/Province

Osaka

ZIP/Postal Code

556-0017

Country

Japan

Facility Name

Eisai Trial Site 1

City

Osaka-shi

State/Province

Osaka

ZIP/Postal Code

534-0021

Country

Japan

Facility Name

Eisai Trial Site 3

City

Osaka-shi

State/Province

Osaka

ZIP/Postal Code

543-8555

Country

Japan

Facility Name

Eisai Trial Site 2

City

Osaka-shi

State/Province

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Eisai Trial site 2

City

Sakai-shi

State/Province

Osaka

ZIP/Postal Code

593-8301

Country

Japan

Facility Name

Eisai Trial Site 1

City

Suita-shi

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Eisai Trial Site 2

City

Suita-shi

State/Province

Osaka

ZIP/Postal Code

565-0874

Country

Japan

Facility Name

Eisai Trial Site 1

City

Suminoe-ku

State/Province

Osaka

ZIP/Postal Code

559-0004

Country

Japan

Facility Name

Eisai Trial Site 1

City

Kanzaki-gun

State/Province

Saga

ZIP/Postal Code

842-0192

Country

Japan

Facility Name

Eisai Trial Site 1

City

Otsu-shi

State/Province

Shiga

ZIP/Postal Code

520-2192

Country

Japan

Facility Name

Eisai Trial Site 2

City

Otsu

State/Province

Shiga

ZIP/Postal Code

520-0832

Country

Japan

Facility Name

Eisai Trial Site 1

City

Tokushima-shi

State/Province

Tokushima

ZIP/Postal Code

770-8503

Country

Japan

Facility Name

Eisai Trial Site 1

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-0034

Country

Japan

Facility Name

Eisai Trial Site 2

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8603

Country

Japan

Facility Name

Eisai Trial Site 1

City

Kodaira-shi

State/Province

Tokyo

ZIP/Postal Code

187-8551

Country

Japan

Facility Name

Eisai Trial Site 1

City

Minato-ku

State/Province

Tokyo

ZIP/Postal Code

108-0073

Country

Japan

Facility Name

Eisai Trial Site 1

City

Setagaya-ku

State/Province

Tokyo

ZIP/Postal Code

158-8531

Country

Japan

Facility Name

Eisai Trial Site 1

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

169-0073

Country

Japan

Facility Name

Eisai Trial Site 1

City

Sumida-ku

State/Province

Tokyo

ZIP/Postal Code

130-0004

Country

Japan

Facility Name

Eisai Trial Site 1

City

Hofu-shi

State/Province

Yamaguchi

ZIP/Postal Code

747-0802

Country

Japan

Facility Name

Eisai Trial Site 1

City

Kumamoto

ZIP/Postal Code

860-8556

Country

Japan

Facility Name

Eisai Trial Site 3

City

Kyoto

ZIP/Postal Code

606-0851

Country

Japan

Facility Name

Eisai Trial Site 1

City

Osaka

ZIP/Postal Code

553-0003

Country

Japan

Facility Name

Facility #1

City

Bucheon-si

State/Province

Gyeonggi-do

ZIP/Postal Code

14647

Country

Korea, Republic of

Facility Name

Facility #1

City

Seongnam

State/Province

Gyeonggi

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Facility #1

City

Busan

ZIP/Postal Code

49201

Country

Korea, Republic of

Facility Name

Facility #1

City

Incheon

ZIP/Postal Code

22332

Country

Korea, Republic of

Facility Name

Facility #5

City

Seoul

ZIP/Postal Code

3722

Country

Korea, Republic of

Facility Name

Facility #3

City

Seoul

ZIP/Postal Code

4763

Country

Korea, Republic of

Facility Name

Facility #1

City

Seoul

ZIP/Postal Code

5030

Country

Korea, Republic of

Facility Name

Facility #4

City

Seoul

ZIP/Postal Code

6351

Country

Korea, Republic of

Facility Name

Facility #6

City

Seoul

ZIP/Postal Code

6973

Country

Korea, Republic of

Facility Name

Facility #2

City

Seoul

ZIP/Postal Code

7985

Country

Korea, Republic of

Facility Name

Facility #1

City

Katowice

Country

Poland

Facility Name

Facility #1

City

Kielce

ZIP/Postal Code

25-411

Country

Poland

Facility Name

Facility #1

City

Krakow

ZIP/Postal Code

30-149

Country

Poland

Facility Name

Facility #1

City

Poznari

ZIP/Postal Code

61-853

Country

Poland

Facility Name

Facility #1

City

Poznań

Country

Poland

Facility Name

Facility #1

City

Siemianowice Śląskie

ZIP/Postal Code

41-100

Country

Poland

Facility Name

Facility #1

City

Warszawa

ZIP/Postal Code

01-684

Country

Poland

Facility Name

Facility #1

City

Guimarães

ZIP/Postal Code

4835-044

Country

Portugal

Facility Name

Facility #1

City

Moscow

ZIP/Postal Code

119991

Country

Russian Federation

Facility Name

Facility #1

City

Bratislava

ZIP/Postal Code

85107

Country

Slovakia

Facility Name

Facility #1

City

Elche

State/Province

Alicante

ZIP/Postal Code

3203

Country

Spain

Facility Name

Facility #1

City

Sant Cugat Del Valles

State/Province

Barcelona

ZIP/Postal Code

8195

Country

Spain

Facility Name

Facility #1

City

Getxo

State/Province

Bizkaia

ZIP/Postal Code

48993

Country

Spain

Facility Name

Facility #1

City

Donostia/San Sebastian

State/Province

Gipuzkoa

ZIP/Postal Code

20009

Country

Spain

Facility Name

Facility #1

City

Palma de Mallorca

State/Province

Illes Balears

ZIP/Postal Code

7120

Country

Spain

Facility Name

Facility #1

City

El Palmar

State/Province

Murcia

ZIP/Postal Code

30120

Country

Spain

Facility Name

Facility #1

City

Barcelona

ZIP/Postal Code

8028

Country

Spain

Facility Name

Facility #2

City

Madrid

ZIP/Postal Code

28049

Country

Spain

Facility Name

Facility #1

City

Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

Facility #1

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Facility #2

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Facility #1

City

Cambridge

State/Province

Cambridgeshire

ZIP/Postal Code

CB21 5EF

Country

United Kingdom

Facility Name

Facility #1

City

Chester

State/Province

Cheshire

ZIP/Postal Code

CH2 1BQ

Country

United Kingdom

Facility Name

Facility #1

City

Winwick, Warrington

State/Province

Cheshire

ZIP/Postal Code

WA2 8WA

Country

United Kingdom

Facility Name

Facility #1

City

Plymouth

State/Province

Devon

ZIP/Postal Code

PL6 8BT

Country

United Kingdom

Facility Name

Facility #1

City

Bournemouth

State/Province

Dorset

ZIP/Postal Code

BH1 4JQ

Country

United Kingdom

Facility Name

Facility #1

City

Crowborough

State/Province

East Sussex

ZIP/Postal Code

TN6 1HB

Country

United Kingdom

Facility Name

Facility #1

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Facility #1

City

Southampton

State/Province

Hampshire

ZIP/Postal Code

SO30 3JB

Country

United Kingdom

Facility Name

Facility #1

City

Glasgow

State/Province

Lanarkshire

ZIP/Postal Code

G20 0XA

Country

United Kingdom

Facility Name

Facility #1

City

Blackpool

State/Province

Lancashire

ZIP/Postal Code

FY2 0JH

Country

United Kingdom

Facility Name

Facility #1

City

Preston

State/Province

Lancashire

ZIP/Postal Code

PR2 8DW

Country

United Kingdom

Facility Name

Facility #2

City

London

State/Province

Middlesex

ZIP/Postal Code

TW7 6FY

Country

United Kingdom

Facility Name

Facility #1

City

Bath

State/Province

North East Somerset

ZIP/Postal Code

BA1 3NG

Country

United Kingdom

Facility Name

Facility #1

City

Oxford

State/Province

Oxfordshire

ZIP/Postal Code

OX3 7JX

Country

United Kingdom

Facility Name

Facility #1

City

Aberdeen

State/Province

Scotland

ZIP/Postal Code

AB25 2ZH

Country

United Kingdom

Facility Name

Facility #1

City

Sheffield

State/Province

South Yorkshire

ZIP/Postal Code

S5 7JT

Country

United Kingdom

Facility Name

Facility #1

City

Leatherhead

State/Province

Surrey

ZIP/Postal Code

KT22 7AD

Country

United Kingdom

Facility Name

Facility #1

City

Birmingham

State/Province

West Midlands

ZIP/Postal Code

B168QQ

Country

United Kingdom

Facility Name

Facility #1

City

Swindon

State/Province

Wilts

ZIP/Postal Code

SN3 6BW

Country

United Kingdom

Facility Name

Facility #2

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

Facility #1

City

Guildford

ZIP/Postal Code

GU2 7YD

Country

United Kingdom

Facility Name

Facility #1

City

London

ZIP/Postal Code

W1G 9RU

Country

United Kingdom

Facility Name

Facility #4

City

London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

Facility #3

City

London

ZIP/Postal Code

WC1X 8QD

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35897078

Citation

Bullich S, Mueller A, De Santi S, Koglin N, Krause S, Kaplow J, Kanekiyo M, Roe-Vellve N, Perrotin A, Jovalekic A, Scott D, Gee M, Stephens A, Irizarry M. Evaluation of tau deposition using 18F-PI-2620 PET in MCI and early AD subjects-a MissionAD tau sub-study. Alzheimers Res Ther. 2022 Jul 27;14(1):105. doi: 10.1186/s13195-022-01048-x.

Results Reference

derived

Learn more about this trial

A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Participants With Early Alzheimer's Disease

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A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Participants With Early Alzheimer's Disease (MissionAD1)

Alzheimer's Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial