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Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ACC-001 3 μg/ QS-21 50 μg

ACC-001 10 μg/ QS-21 50 μg

Placebo- Phosphate buffered saline (PBS)

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Early Alzheimer's disease, active immunization, amyloid imaging

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Concern about a change in cognition expressed by the subject or by an informant that knows the subject well
Mini-Mental State Examination (MMSE) score ≥ 25
Global Clinical Dementia Rating = 0.5.
General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's dementia cannot not be made by the site physician at the time of screening.
Amyloid burden detected on screening brain PET scan.
Other inclusion criteria apply.

Exclusion Criteria:

Significant neurological disease other than early Alzheimer's disease
Major psychiatric disorder or symptom
Contraindication to undergo brain MRI
Unstable medical conditions
Other exclusion criteria apply

Sites / Locations

Banner Alzheimer's Institute
Banner Good Samaritan Medical Center
Banner Boswell Medical Center
Banner Lakes Imaging Center
Banner Sun Health Research Institute
Southwest PET Institute
University of Arizona, Health Sciences Center - Department of Neurology
Universal Medical Center
Northwest NeuroSpecialists, LLC
Radiology Limited
Pacific Neuroscience Medical Group
GCRC (Drug administered)
Yale University School of Medicine, Alzheimer's Disease Research Unit
Investigational Drug Service
Norman S. Werdiger, MD
Clinical Research Unit
Georgetown University Hospital
Georgetown University Medical Center Department of Neurology
Meridien Research
Florida Neurology Group PL
Internal Medicine Associates of Lee County, MD, PA
Neuropsychiatric Research Center of Southwest Florida
Florida Radiology Leasing, Limited Liability Corporation
Radiology Regional Center
Mount Sinai Medical Center
Miami Jewish Health Systems
Premiere Research Institute (Palm Beach Neurology)
Massachusetts General Hospital (For PET only)
Brigham and Women's Hospital
University of Nebraska Medical Center
Cleveland Clinic Lou Ruvo Center for Brain Health
Steinberg Diagnostic Imaging
Nevada Cancer Institute
Memory Enhancement Center of America, Incorporated
Satatoga PET Associates
Rhode Island Mood and Memory Research Institute
Butler Hospital
Baylor College of Medicine, Department of Neurology
The Memory Clinic
The Pharmacy Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

ACC-001 3 μg/ QS-21 50 μg

ACC-001 10 μg/ QS-21 50 μg

Placebo- Phosphate buffered saline (PBS)

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs)

Fibrillar brain Aβ was measured by retention of florbetapir F18 as measured by positron emission tomography (PET) scans. A positive change indicating an improvement from baseline.

Secondary Outcome Measures

Full Information

NCT ID

NCT01227564

First Posted

October 22, 2010

Last Updated

January 28, 2016

Sponsor

Pfizer

Collaborators

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT01227564

Brief Title

Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease

Official Title

A Phase 2, Multicenter, 24-month, Randomized, Third-party Unblinded, Placebo-controlled, Parallel-group Amyloid Imaging Positron Emission Tomography (Pet) And Safety Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Early Alzheimer's Disease.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

Collaborators

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study in individuals with early Alzheimer's disease is designed to assess:(1) safety and tolerability (2) the capacity of ACC-001 and QS-21 adjuvant to reduce brain amyloid load as measured by positron emission tomography (PET) scans.

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, active immunization, amyloid imaging

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ACC-001 3 μg/ QS-21 50 μg

Arm Type

Experimental

Arm Title

ACC-001 10 μg/ QS-21 50 μg

Arm Type

Experimental

Arm Title

Placebo- Phosphate buffered saline (PBS)

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

ACC-001 3 μg/ QS-21 50 μg

Other Intervention Name(s)

Vanutide Cridificar

Intervention Description

ACC-001 3 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18

Intervention Type

Biological

Intervention Name(s)

ACC-001 10 μg/ QS-21 50 μg

Other Intervention Name(s)

Vanutide Cridificar

Intervention Description

ACC-001 10 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18

Intervention Type

Other

Intervention Name(s)

Placebo- Phosphate buffered saline (PBS)

Intervention Description

Phosphate buffered saline IM on day 1, month 1, month 3, month 6, month 12, and month 18

Primary Outcome Measure Information:

Title

Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs)

Description

Fibrillar brain Aβ was measured by retention of florbetapir F18 as measured by positron emission tomography (PET) scans. A positive change indicating an improvement from baseline.

Time Frame

104 weeks

Other Pre-specified Outcome Measures:

Title

Change From Baseline in Cerebrospinal Fluid (CSF) Aβ x-40

Description

For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at the Early termination (ET) visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.

Time Frame

Week 80 or Week 104

Title

Change From Baseline in CSF Aβ x-42

Description

For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at ET visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.

Time Frame

Week 80 or Week 104

Title

Change From Baseline in CSF p-Tau

Description

For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at ET visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.

Time Frame

Week 80 or Week 104

Title

Change From Baseline in CSF Total Tau

Description

For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at ET visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.

Time Frame

Week 80 or Week 104

Title

Change From Baseline in Plasma Aβ x-40

Description

Site personnel collecting the samples for plasma Aβ (x-40) concentrations and the results were blinded to the participant treatment group assignment.

Time Frame

104 weeks

Title

Change From Baseline in Volumetric Brain Magnetic Resonance Imaging (MRI) Measurements in Brain Boundary Shift Integral (BBSI)

Description

BBSI measures whole brain atrophy from registered MRI scan pairs, by subtracting the area under the intensity profile across a boundary in the repeat scans from the initial scan (baseline).

Time Frame

104 weeks

Title

Change From Baseline in Volumetric Brain MRI Measurements in Ventricular Boundary Shift Integral (VBSI)

Description

VBSI measures ventricular volume change from registered MRI scan pairs, by subtracting the area under the intensity profile across a boundary in the repeat scans.

Time Frame

104 weeks

Title

Change From Baseline in Volumetric Brain MRI Measurements in Hippocampal Boundary Shift Integral (HBSI), Total

Description

Left HBSI and Right HBSI respectively measure the left hippocampal atrophy and the right hippocampal atrophy from registered MRI scan pairs, by subtracting the corresponding area under the intensity profile across a boundary in the repeat scans. HBSI (Total) is defined as the summation of the left HBSI and the right HBSI.

Time Frame

104 weeks

Title

Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Left

Description

Left HBSI measures the left hippocampal atrophy from registered MRI scan pairs, by subtracting the corresponding area under the intensity profile across a boundary in the repeat scans.

Time Frame

104 weeks

Title

Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Right

Description

Right HBSI measures the right hippocampal atrophy from registered MRI scan pairs, by subtracting the corresponding area under the intensity profile across a boundary in the repeat scans.

Time Frame

104 weeks

Title

Change From Baseline in Neuropsychological Test Battery (NTB)

Description

The NTB evaluated cognitive domains that are known to be affected early in the course of Alzheimer's disease (AD). The cognitive tests included in the NTB were: Rey Auditory Verbal Learning Test - Immediate recall, Detection, Identification, Go-No-Go Task, One Back Task, Controlled Oral Word Association Test, Category Fluency Test, and Rey Auditory Verbal Learning Test - delayed recall and recognition. For each of the eight NTB components, an individual z-score was derived based on the primary raw score of each test. Based on the individual z-scores, a composite z-score was derived using the formula: (z1-z2-z3-z4+z5+z6+z7+z8)/8. Positive change indicating an improvement from baseline.

Time Frame

104 weeks

Title

Change From Baseline in Functional Activities Questionnaire (FAQ) Total Score

Description

FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from shopping, doing the laundry, simple financial transactions, comprehension of current events, some recreational or avocational activities, and reading. FAQ total score was calculated by adding the scores from each of the 10 items. A negative change indicated an improvement from baseline. FAQ Total Score is the sum of 10 items, ranging from 0 (best possible outcome) to 100 (worst possible outcome).

Time Frame

104 weeks

Title

Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB)

Description

Clinical Dementia Rating (CDR) is a global clinical staging instrument that was administrated by a trained rater to assess a participant's level of impairment in six domains including: Memory, Orientation, Judgement and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care, based on the CDR interview. The CDR included discussions with the participant and study partner using a structured format. A CDR-SOB score was derived based on individual scores from the six domains. A negative change indicated an improvement from baseline. The total CDR-SB score is calculated as the sum of the six clinical ratings. The CDR-SOB score range for each domain is 0 to 3. The CDR-SOB total score ranges from 0 to 18, with higher scores indicating greater dementia. If any individual item is missing, then the CDR-SB is set to missing.

Time Frame

104 weeks

Title

Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score

Description

The NPI scale assesses 12 domains (delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behavior, nighttime behavior, and appetite and eating changes). The symptoms were rated on the basis of questions administered to the study partner. If a preliminary question for each domain was answered as 'Yes', each domain was rated on a 4-point frequency scale and on a 3-point severity scale. If the preliminary question was answered as 'No', the frequency, severity, and distress scales were set to zero. A negative change indicated an improvement from baseline. For each of the 12 domains, a sub-scale score is calculated as frequency*severity and ranges from 0 to 12. The NPI total score is then calculated by summing the scores of the 12 sub-scale scores. The NPI total scores ranges from 0 to 144 with higher scores indicating greater behavioral impairment. The caregiver distress score is not included in the NPI total score.

Time Frame

104 weeks

Title

Change From Baseline in NPI Distress Score (NPI-D)

Description

The NPI scale assesses 12 domains (delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behavior, nighttime behavior, and appetite and eating changes). The symptoms were rated on the basis of questions administered to the study partner. For each domain, the study partner also rated his/her own 'emotional or psychological' distress caused by the participant's behavior on a 6-point scale. The study partner NPI-D total score was calculated by summing the scores of the 12 sub-scale distress scores. A negative change indicated an improvement from baseline. The caregiver distress (NPI-D) total score is calculated by summing the scores of the 12 sub-scale distress scores. The NPI-D total scores ranges from 0 to 60 with higher scores indicating greater distress.

Time Frame

104 weeks

Title

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

Description

The MMSE is a brief, structured examination of cognitive function consisting of the 11 item: Orientation-What, Orientation-Where, Registration-Objects, Attention and Calculation, Recall, Language-Naming, Language-Repetition, Language-Comprehension, Language-Reading, Language-Writing, and Language- Drawing. MMSE total score was the sum of the 11 item scores and it ranges from 0 to 30 with higher score indicating greater cognitive functioning. If any individual item is missing, then the MMSE total score is set to missing. A positive change indicating an improvement from baseline.

Time Frame

104 weeks

Title

Change From Baseline in 13-item Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) Total Score

Description

The ADAS-Cog is a global cognitive measure. For the following 13 items, the participants were rated: Word Recall, Commands, Construction Praxis, Delayed Word Recall Task, Naming Task, Ideational Praxis, Orientation, Word Recognition Task, Remembering Test Instructions, Spoken Language Ability, Word-Finding Difficulty in Spontaneous Speech, Comprehension, and Number Cancellation. The ADAS-cog is a structured scale that evaluates memory, orientation, attention, reasoning, language and constructional praxis. The total score was the sum of the scores from the 13 individual items. This study used a modified 85 point scale with a scoring range of 0 to 85 (13 items). Higher scores of the 13 individual items indicated greater cognitive impairment.

Time Frame

104 weeks

Title

Change From Baseline in Dependence Scale (DS) Score

Description

An abbreviated administration (first 6 items) of the DS was used in this study. The DS is a brief study partner-completed measure which assesses the degree of support required by a subject with AD. Since the goal of treatment was to delay or arrest the processes leading to increased dependence, the DS represented a meaningful endpoint for clinical studies in AD. The dependence score was derived by summing the first 6 items of the DS. Item 1 and 2 ranged from 0 - 2 and item 3 - 6 ranged from 0 - 1. The total score was calculated by summing the score from each of the 6 items. So the total score could range from 0 - 8, with higher scores indicating greater dependence.

Time Frame

104 weeks

Title

Change From Baseline in Resource Utilization in Dementia (RUD) (Abbreviated) (RUD-Lite) - Primary Caregiver

Description

An abbreviated administration of the RUD (RUD-Lite) was used. The RUD-Lite is a comprehensive tool for addressing the magnitude and nature of study partner/caregiver effort in cases of dementia. Since a significant portion of care in Alzheimer's related-dementia was performed informally by the participant's friends or family, it was desirable to measure the extent of this care for use in economic evaluations of disease. The total time spent by the primary caregiver providing support on activities of daily living (ADL), instrumental activities of daily living (IADL) and supervising, respectively, was calculated in two components. Total number of days spent during the past month on each of ADL, IADL, and supervising; and: time per day during the past month on each of ADL, IADL and supervising. The total Primary Caregiver Time per month could range from 0 - 720. This was calculated by multiplying the number of days per month (30) by the number of hours per day (24).

Time Frame

104 weeks

Title

Change From Baseline in RUD (Abbreviated) (RUD-Lite) - Other Caregivers

Description

An abbreviated administration of the RUD (RUD-Lite) was used. The RUD-Lite is a comprehensive tool for addressing the magnitude and nature of study partner/caregiver effort in cases of dementia. Since a significant portion of care in Alzheimer's related-dementia was performed informally by the participant's friends or family, it was desirable to measure the extent of this care for use in economic evaluations of disease. The total time spent by the other caregivers providing support on ADL, IADL and supervising, respectively, was calculated in two components. Total number of days spent during the past month on each of ADL, IADL and supervising; and: time per day during the past month on each of ADL, IADL, and supervising. The total Other Caregiver Time per month could range from 0 - 720. This was calculated by multiplying the number of days per month (30) by the number of hours per day (24).

Time Frame

104 weeks

Title

Percentage of Participants With a Global CDR Score of Equal to or Greater Than 1 for the First Time

Description

CDR is a global clinical staging instrument that was administrated by a trained rater to assess a participant's level of impairment in six domains including: Memory, Orientation, Judgement and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care, based on the CDR interview. The CDR included discussions with the participant and study partner using a structured format. CDR global score was derived from the six domains according to a complex algorithm with emphasis on the Memory Domain score. Global CDR score = 0.5 with memory box score of 0.5. The total CDR-SB score is calculated as the sum of the six clinical ratings. The CDR-SOB score range for each domain is 0 to 3, with higher score indicating no significant function. If any individual item is missing, then the CDR-SB is set to missing.

Time Frame

104 weeks

Title

Geometric Mean Anti-Aβ IgG Enzyme-linked Immunosorbent Assay (ELISA) Titers

Description

Site personnel collecting the samples for anti-Aβ antibody titers were blinded to the participant treatment group assignment. The lower limit of quantification (LLOQ) determined for this assay was 100 U/mL. For any anti-Aβ IgG antibody level that was below the LLOQ (100 U/mL), the lower limit of detection (LLOD) defined as 0.5*LLOQ was imputed.

Time Frame

104 weeks

Title

Geometric Mean Anti-Aβ IgM ELISA Titers

Description

Site personnel collecting the samples for anti-Aβ antibody titers were blinded to the participant treatment group assignment. The LLOQ determined for this assay was 50 U/mL. For any anti-Aβ IgM antibody level that was below the LLOQ (50 U/mL), the LLOD defined as 0.5*LLOQ was imputed.

Time Frame

104 weeks

Title

Change From Baseline in Perceived Deficits Questionnaire (PDQ) - Subject - Attention/Concentration Domain Score

Description

The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant's perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Attention/Concentration Domain Score is the sum of the raw scores on items 1, 5, 9, 13 and 17, with a range from 0 - 4 for each of the 5 items. So the Attention/Concentration Domain Score could range from 0 - 20, with higher scores indicating greater perceived cognitive impairment.

Time Frame

104 weeks

Title

Change From Baseline in PDQ - Subject - Retrospective Memory Domain Score

Description

The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant's perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Retrospective Memory Domain Score is the sum of the raw scores on items 2, 6, 10, 14, and 18, with a range from 0 - 4 for each of the 5 items. So the Retrospective Memory Domain Score could range from 0 - 20, with higher scores indicating greater perceived cognitive impairment.

Time Frame

104 weeks

Title

Change From Baseline in PDQ - Subject - Prospective Memory Domain Score

Description

The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant's perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Prospective Memory Domain Score is the sum of the raw scores on items 3, 7, 11, 15, and 19, with a range from 0 - 4 for each of the 5 items. So the Prospective Memory Domain Score could range from 0 - 20, with higher scores indicating greater perceived cognitive impairment.

Time Frame

104 weeks

Title

Change From Baseline in PDQ - Subject - Planning/Organization Domain Score

Description

The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant's perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Planning/Organization Domain Score is the sum of the raw scores on items 4, 8, 12, 16, and 20, with a range from 0 - 4 for each of the 5 items. So the Planning/Organization Domain Score could range from 0 - 20, with higher scores indicating greater perceived cognitive impairment.

Time Frame

104 weeks

Title

Change From Baseline in PDQ - Subject - Total Score

Description

The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant's perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Total Score is computed by adding raw scores for all of the items (or all 4 domain scores) together. It could range from 0 - 80, with higher scores indicating greater perceived cognitive impairment.

Time Frame

104 weeks

Title

Change From Baseline in PDQ-R - Relative - Attention/Concentration Domain Score

Description

The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Attention/Concentration Domain Score is the sum of the raw scores on items 1, 5, 9, 13, and 17, with a range from 0 - 4 for each of the 5 items. So the Attention/Concentration Domain Score could range from 0 - 20, with higher scores indicating greater perceived cognitive impairment.

Time Frame

104 weeks

Title

Change From Baseline in PDQ-R - Relative - Retrospective Memory Domain Score

Description

The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Retrospective Memory Domain Score is the sum of the raw scores on items 2, 6, 10, 14, and 18, with a range from 0 - 4 for each of the 5 items. So the Retrospective Memory Domain Score could range from 0 - 20, with higher scores indicating greater perceived cognitive impairment.

Time Frame

104 weeks

Title

Change From Baseline in PDQ-R - Relative - Prospective Memory Domain Score

Description

The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Prospective Memory Domain Score is the sum of the raw scores on items 3, 7, 11, 15, and 19, with a range from 0 - 4 for each of the 5 items. So the Prospective Memory Domain Score could range from 0 - 20, with higher scores indicating greater perceived cognitive impairment.

Time Frame

104 weeks

Title

Change From Baseline in PDQ-R - Relative - Planning/Organization Domain Score

Description

The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Planning/Organization Domain Score is the sum of the raw scores on items 4, 8, 12, 16, and 20, with a range from 0 - 4 for each of the 5 items. So the Planning/Organization Domain Score could range from 0 - 20, with higher scores indicating greater perceived cognitive impairment.

Time Frame

104 weeks

Title

Change From Baseline in PDQ-R - Relative - Total Score

Description

The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Total Score is computed by adding raw scores for all of the items (or all 4 domain scores) together. It could range from 0 - 80, with higher scores indicating greater perceived cognitive impairment.

Time Frame

104 weeks

Title

Alzheimer's Disease Medication Administration Concerns Questionnaire (AD MACQ)

Description

The AD MACQ was administered to the study partner to address preferences for medication administration by assessing: Question a: I would find it easy to give the study medication to the patient myself. Question b: The number of times the medication was given was convenient. Question c: I would prefer to have the study medication given at home by me instead of at the doctor's office by the doctor or nurse. Question d: I would prefer to have the study medication given at home by a nurse instead of at the doctor's office by the doctor or nurse. Question e: Overall, I am satisfied with the way the medication was given.

Time Frame

104 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Concern about a change in cognition expressed by the subject or by an informant that knows the subject well Mini-Mental State Examination (MMSE) score ≥ 25 Global Clinical Dementia Rating = 0.5. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's dementia cannot not be made by the site physician at the time of screening. Amyloid burden detected on screening brain PET scan. Other inclusion criteria apply. Exclusion Criteria: Significant neurological disease other than early Alzheimer's disease Major psychiatric disorder or symptom Contraindication to undergo brain MRI Unstable medical conditions Other exclusion criteria apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Banner Alzheimer's Institute

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

Banner Good Samaritan Medical Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

Banner Boswell Medical Center

City

Sun City

State/Province

Arizona

ZIP/Postal Code

85351

Country

United States

Facility Name

Banner Lakes Imaging Center

City

Sun City

State/Province

Arizona

ZIP/Postal Code

85351

Country

United States

Facility Name

Banner Sun Health Research Institute

City

Sun City

State/Province

Arizona

ZIP/Postal Code

85351

Country

United States

Facility Name

Southwest PET Institute

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85719

Country

United States

Facility Name

University of Arizona, Health Sciences Center - Department of Neurology

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724-5023

Country

United States

Facility Name

Universal Medical Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Northwest NeuroSpecialists, LLC

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85741

Country

United States

Facility Name

Radiology Limited

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85741

Country

United States

Facility Name

Pacific Neuroscience Medical Group

City

Oxnard

State/Province

California

ZIP/Postal Code

93030

Country

United States

Facility Name

GCRC (Drug administered)

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Yale University School of Medicine, Alzheimer's Disease Research Unit

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Investigational Drug Service

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

Facility Name

Norman S. Werdiger, MD

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

Facility Name

Clinical Research Unit

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Georgetown University Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Georgetown University Medical Center Department of Neurology

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20057

Country

United States

Facility Name

Meridien Research

City

Brooksville

State/Province

Florida

ZIP/Postal Code

34601

Country

United States

Facility Name

Florida Neurology Group PL

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33907

Country

United States

Facility Name

Internal Medicine Associates of Lee County, MD, PA

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33912

Country

United States

Facility Name

Neuropsychiatric Research Center of Southwest Florida

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33912

Country

United States

Facility Name

Florida Radiology Leasing, Limited Liability Corporation

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33919

Country

United States

Facility Name

Radiology Regional Center

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33919

Country

United States

Facility Name

Mount Sinai Medical Center

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

Facility Name

Miami Jewish Health Systems

City

Miami

State/Province

Florida

ZIP/Postal Code

33137

Country

United States

Facility Name

Premiere Research Institute (Palm Beach Neurology)

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Massachusetts General Hospital (For PET only)

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68105

Country

United States

Facility Name

Cleveland Clinic Lou Ruvo Center for Brain Health

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Steinberg Diagnostic Imaging

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Nevada Cancer Institute

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89135

Country

United States

Facility Name

Memory Enhancement Center of America, Incorporated

City

Eatontown

State/Province

New Jersey

ZIP/Postal Code

07724

Country

United States

Facility Name

Satatoga PET Associates

City

Clifton Park

State/Province

New York

ZIP/Postal Code

12065

Country

United States

Facility Name

Rhode Island Mood and Memory Research Institute

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02914

Country

United States

Facility Name

Butler Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

Facility Name

Baylor College of Medicine, Department of Neurology

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

The Memory Clinic

City

Bennington

State/Province

Vermont

ZIP/Postal Code

05201

Country

United States

Facility Name

The Pharmacy Inc.

City

Bennington

State/Province

Vermont

ZIP/Postal Code

05201

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29210443

Citation

van Dyck CH, Sadowsky C, Le Prince Leterme G, Booth K, Peng Y, Marek K, Ketter N, Liu E, Wyman BT, Jackson N, Slomkowski M, Ryan JM. Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Individuals with Early Alzheimer's Disease: Amyloid Imaging Positron Emission Tomography and Safety Results from a Phase 2 Study. J Prev Alzheimers Dis. 2016;3(2):75-84. doi: 10.14283/jpad.2016.91.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2571010&StudyName=Amyloid%20Imaging%20And%20Safety%20Study%20Of%20ACC-001%20In%20Subjects%20With%20Early%20Alzheimer%27s%20Disease

Description

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Learn more about this trial

Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease

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