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

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.

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Biological: ACC-001 3 μg/ QS-21 50 μg; Biological: ACC-001 10 μg/ QS-21 50 μg; Other: Placebo- Phosphate buffered saline (PBS)

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Alzheimer's Institute
    • Phoenix, Arizona, United States, 85006
      • Banner Good Samaritan Medical Center
    • Sun City, Arizona, United States, 85351
      • Banner Sun Health Research Institute
    • Sun City, Arizona, United States, 85351
      • Banner Boswell Medical Center
    • Sun City, Arizona, United States, 85351
      • Banner Lakes Imaging Center
    • Tucson, Arizona, United States, 85741
      • Northwest NeuroSpecialists, LLC
    • Tucson, Arizona, United States, 85719
      • Southwest PET Institute
    • Tucson, Arizona, United States, 85724-5023
      • University of Arizona, Health Sciences Center - Department of Neurology
    • Tucson, Arizona, United States, 85724
      • Universal Medical Center
    • Tucson, Arizona, United States, 85741
      • Radiology Limited
  • California
    • Oxnard, California, United States, 93030
      • Pacific Neuroscience Medical Group
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine, Alzheimer's Disease Research Unit
    • New Haven, Connecticut, United States, 06511
      • Investigational Drug Service
    • New Haven, Connecticut, United States, 06519
      • Norman S. Werdiger, MD
    • New Haven, Connecticut, United States, 06510
      • GCRC (Drug administered)
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital
    • Washington, District of Columbia, United States, 20007
      • Clinical Research Unit
    • Washington, District of Columbia, United States, 20057
      • Georgetown University Medical Center Department of Neurology
  • Florida
    • Brooksville, Florida, United States, 34601
      • Meridien Research
    • Fort Myers, Florida, United States, 33912
      • Neuropsychiatric Research Center of Southwest Florida
    • Fort Myers, Florida, United States, 33919
      • Radiology Regional Center
    • Fort Myers, Florida, United States, 33907
      • Florida Neurology Group PL
    • Fort Myers, Florida, United States, 33912
      • Internal Medicine Associates of Lee County, MD, PA
    • Fort Myers, Florida, United States, 33919
      • Florida Radiology Leasing, Limited Liability Corporation
    • Miami, Florida, United States, 33137
      • Miami Jewish Health Systems
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute (Palm Beach Neurology)
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital (For PET only)
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • University of Nebraska Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Cleveland Clinic Lou Ruvo Center for Brain Health
    • Las Vegas, Nevada, United States, 89135
      • Nevada Cancer Institute
    • Las Vegas, Nevada, United States, 89128
      • Steinberg Diagnostic Imaging
  • New Jersey
    • Eatontown, New Jersey, United States, 07724
      • Memory Enhancement Center of America, Incorporated
  • New York
    • Clifton Park, New York, United States, 12065
      • Satatoga PET Associates
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Rhode Island mood and memory research institute
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine, Department of Neurology
  • Vermont
    • Bennington, Vermont, United States, 05201
      • The Memory Clinic
    • Bennington, Vermont, United States, 05201
      • The Pharmacy Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACC-001 3 μg/ QS-21 50 μg	Biological: ACC-001 3 μg/ QS-21 50 μg; ACC-001 3 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18; Other Names: Vanutide Cridificar
Experimental: ACC-001 10 μg/ QS-21 50 μg	Biological: ACC-001 10 μg/ QS-21 50 μg; ACC-001 10 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18; Other Names: Vanutide Cridificar
Placebo Comparator: Placebo- Phosphate buffered saline (PBS)	Other: Placebo- Phosphate buffered saline (PBS); Phosphate buffered saline IM on day 1, month 1, month 3, month 6, month 12, and month 18

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	104 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Cerebrospinal Fluid (CSF) Aβ x-40	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.	Week 80 or Week 104
Change From Baseline in CSF Aβ x-42	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.	Week 80 or Week 104
Change From Baseline in CSF p-Tau	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.	Week 80 or Week 104
Change From Baseline in CSF Total Tau	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.	Week 80 or Week 104
Change From Baseline in Plasma Aβ x-40	Site personnel collecting the samples for plasma Aβ (x-40) concentrations and the results were blinded to the participant treatment group assignment.	104 weeks
Change From Baseline in Volumetric Brain Magnetic Resonance Imaging (MRI) Measurements in Brain Boundary Shift Integral (BBSI)	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).	104 weeks
Change From Baseline in Volumetric Brain MRI Measurements in Ventricular Boundary Shift Integral (VBSI)	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.	104 weeks
Change From Baseline in Volumetric Brain MRI Measurements in Hippocampal Boundary Shift Integral (HBSI), Total	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.	104 weeks
Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Left	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.	104 weeks
Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Right	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.	104 weeks
Change From Baseline in Neuropsychological Test Battery (NTB)	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.	104 weeks
Change From Baseline in Functional Activities Questionnaire (FAQ) Total Score	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).	104 weeks
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB)	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.	104 weeks
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score	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.	104 weeks
Change From Baseline in NPI Distress Score (NPI-D)	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.	104 weeks
Change From Baseline in Mini Mental State Examination (MMSE) Total Score	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.	104 weeks
Change From Baseline in 13-item Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) Total Score	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.	104 weeks
Change From Baseline in Dependence Scale (DS) Score	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.	104 weeks
Change From Baseline in Resource Utilization in Dementia (RUD) (Abbreviated) (RUD-Lite) - Primary Caregiver	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).	104 weeks
Change From Baseline in RUD (Abbreviated) (RUD-Lite) - Other Caregivers	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).	104 weeks
Percentage of Participants With a Global CDR Score of Equal to or Greater Than 1 for the First Time	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.	104 weeks
Geometric Mean Anti-Aβ IgG Enzyme-linked Immunosorbent Assay (ELISA) Titers	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.	104 weeks
Geometric Mean Anti-Aβ IgM ELISA Titers	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.	104 weeks
Change From Baseline in Perceived Deficits Questionnaire (PDQ) - Subject - Attention/Concentration Domain Score	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.	104 weeks
Change From Baseline in PDQ - Subject - Retrospective Memory Domain Score	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.	104 weeks
Change From Baseline in PDQ - Subject - Prospective Memory Domain Score	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.	104 weeks
Change From Baseline in PDQ - Subject - Planning/Organization Domain Score	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.	104 weeks
Change From Baseline in PDQ - Subject - Total Score	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.	104 weeks
Change From Baseline in PDQ-R - Relative - Attention/Concentration Domain Score	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.	104 weeks
Change From Baseline in PDQ-R - Relative - Retrospective Memory Domain Score	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.	104 weeks
Change From Baseline in PDQ-R - Relative - Prospective Memory Domain Score	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.	104 weeks
Change From Baseline in PDQ-R - Relative - Planning/Organization Domain Score	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.	104 weeks
Change From Baseline in PDQ-R - Relative - Total Score	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.	104 weeks
Alzheimer's Disease Medication Administration Concerns Questionnaire (AD MACQ)	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.	104 weeks

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: October 22, 2010
• First Submitted That Met QC Criteria: October 22, 2010
• First Posted (Estimate): October 25, 2010

Study Record Updates

• Last Update Posted (Estimate): February 25, 2016
• Last Update Submitted That Met QC Criteria: January 28, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: amyloid imaging; Early Alzheimer's disease; active immunization
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Saponin QA-21V1
• Other Study ID Numbers: B2571010; 3134K1-2208 (Other Identifier: Alias Study Number)