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.
2 other identifiers
interventional
63
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2011
Typical duration for phase_2
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2010
CompletedFirst Posted
Study publicly available on registry
October 25, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
February 25, 2016
CompletedFebruary 25, 2016
January 1, 2016
3 years
October 22, 2010
February 9, 2015
January 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (34)
Change From Baseline in Cerebrospinal Fluid (CSF) Aβ x-40
Week 80 or Week 104
Change From Baseline in CSF Aβ x-42
Week 80 or Week 104
Change From Baseline in CSF p-Tau
Week 80 or Week 104
- +31 more other outcomes
Study Arms (3)
ACC-001 3 μg/ QS-21 50 μg
EXPERIMENTALACC-001 10 μg/ QS-21 50 μg
EXPERIMENTALPlacebo- Phosphate buffered saline (PBS)
PLACEBO COMPARATORInterventions
ACC-001 3 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18
ACC-001 10 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18
Phosphate buffered saline IM on day 1, month 1, month 3, month 6, month 12, and month 18
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Significant neurological disease other than early Alzheimer's disease
- Major psychiatric disorder or symptom
- Contraindication to undergo brain MRI
- Unstable medical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006, United States
Banner Boswell Medical Center
Sun City, Arizona, 85351, United States
Banner Lakes Imaging Center
Sun City, Arizona, 85351, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
Southwest PET Institute
Tucson, Arizona, 85719, United States
University of Arizona, Health Sciences Center - Department of Neurology
Tucson, Arizona, 85724-5023, United States
Universal Medical Center
Tucson, Arizona, 85724, United States
Northwest NeuroSpecialists, LLC
Tucson, Arizona, 85741, United States
Radiology Limited
Tucson, Arizona, 85741, United States
Pacific Neuroscience Medical Group
Oxnard, California, 93030, United States
GCRC (Drug administered)
New Haven, Connecticut, 06510, United States
Yale University School of Medicine, Alzheimer's Disease Research Unit
New Haven, Connecticut, 06510, United States
Investigational Drug Service
New Haven, Connecticut, 06511, United States
Norman S. Werdiger, MD
New Haven, Connecticut, 06519, United States
Clinical Research Unit
Washington D.C., District of Columbia, 20007, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Georgetown University Medical Center Department of Neurology
Washington D.C., District of Columbia, 20057, United States
Meridien Research
Brooksville, Florida, 34601, United States
Florida Neurology Group PL
Fort Myers, Florida, 33907, United States
Internal Medicine Associates of Lee County, MD, PA
Fort Myers, Florida, 33912, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
Florida Radiology Leasing, Limited Liability Corporation
Fort Myers, Florida, 33919, United States
Radiology Regional Center
Fort Myers, Florida, 33919, United States
Miami Jewish Health Systems
Miami, Florida, 33137, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Premiere Research Institute (Palm Beach Neurology)
West Palm Beach, Florida, 33407, United States
Massachusetts General Hospital (For PET only)
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68105, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106, United States
Steinberg Diagnostic Imaging
Las Vegas, Nevada, 89128, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
Memory Enhancement Center of America, Incorporated
Eatontown, New Jersey, 07724, United States
Satatoga PET Associates
Clifton Park, New York, 12065, United States
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, 02914, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Baylor College of Medicine, Department of Neurology
Houston, Texas, 77030, United States
The Memory Clinic
Bennington, Vermont, 05201, United States
The Pharmacy Inc.
Bennington, Vermont, 05201, United States
Related Publications (1)
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.
PMID: 29210443DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
In 2013 Pfizer and Janssen Alzheimer Immunotherapy Alliance made the decision that ACC-001 would not be further developed in mild to moderate AD.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2010
First Posted
October 25, 2010
Study Start
February 1, 2011
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
February 25, 2016
Results First Posted
February 25, 2016
Record last verified: 2016-01