Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease
- Conditions
- Alzheimer's Disease
- Interventions
- Other: Placebo- Phosphate buffered saline (PBS)Biological: ACC-001 10 μg/ QS-21 50 μgBiological: ACC-001 3 μg/ QS-21 50 μg
- Registration Number
- NCT01227564
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo- Phosphate buffered saline (PBS) Placebo- Phosphate buffered saline (PBS) - ACC-001 10 μg/ QS-21 50 μg ACC-001 10 μg/ QS-21 50 μg - ACC-001 3 μg/ QS-21 50 μg ACC-001 3 μg/ QS-21 50 μg -
- Primary Outcome Measures
Name Time Method 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) 104 weeks 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
Name Time Method
Trial Locations
- Locations (40)
Banner Lakes Imaging Center
🇺🇸Sun City, Arizona, United States
Universal Medical Center
🇺🇸Tucson, Arizona, United States
Internal Medicine Associates of Lee County, MD, PA
🇺🇸Fort Myers, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Radiology Regional Center
🇺🇸Fort Myers, Florida, United States
Premiere Research Institute (Palm Beach Neurology)
🇺🇸West Palm Beach, Florida, United States
Massachusetts General Hospital (For PET only)
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Baylor College of Medicine, Department of Neurology
🇺🇸Houston, Texas, United States
Northwest NeuroSpecialists, LLC
🇺🇸Tucson, Arizona, United States
The Memory Clinic
🇺🇸Bennington, Vermont, United States
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
🇺🇸Las Vegas, Nevada, United States
Miami Jewish Health Systems
🇺🇸Miami, Florida, United States
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
Steinberg Diagnostic Imaging
🇺🇸Las Vegas, Nevada, United States
Nevada Cancer Institute
🇺🇸Las Vegas, Nevada, United States
Banner Boswell Medical Center
🇺🇸Sun City, Arizona, United States
Banner Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
University of Arizona, Health Sciences Center - Department of Neurology
🇺🇸Tucson, Arizona, United States
Southwest PET Institute
🇺🇸Tucson, Arizona, United States
Pacific Neuroscience Medical Group
🇺🇸Oxnard, California, United States
GCRC (Drug administered)
🇺🇸New Haven, Connecticut, United States
Investigational Drug Service
🇺🇸New Haven, Connecticut, United States
Yale University School of Medicine, Alzheimer's Disease Research Unit
🇺🇸New Haven, Connecticut, United States
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Clinical Research Unit
🇺🇸Washington, District of Columbia, United States
Norman S. Werdiger, MD
🇺🇸New Haven, Connecticut, United States
Meridien Research
🇺🇸Brooksville, Florida, United States
Florida Radiology Leasing, Limited Liability Corporation
🇺🇸Fort Myers, Florida, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Satatoga PET Associates
🇺🇸Clifton Park, New York, United States
Memory Enhancement Center of America, Incorporated
🇺🇸Eatontown, New Jersey, United States
Florida Neurology Group PL
🇺🇸Fort Myers, Florida, United States
Georgetown University Medical Center Department of Neurology
🇺🇸Washington, District of Columbia, United States
Rhode Island Mood and Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
Butler Hospital
🇺🇸Providence, Rhode Island, United States
The Pharmacy Inc.
🇺🇸Bennington, Vermont, United States
Radiology Limited
🇺🇸Tucson, Arizona, United States