Status:
COMPLETED
Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease
Lead Sponsor:
Pfizer
Collaborating Sponsors:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
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 po...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01227564
Start Date
February 1 2011
End Date
February 1 2014
Last Update
February 25 2016
Active Locations (40)
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1
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
2
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
3
Banner Boswell Medical Center
Sun City, Arizona, United States, 85351
4
Banner Lakes Imaging Center
Sun City, Arizona, United States, 85351