NCT01227564CompletedPhase 2
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.
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 63
- Locations
- 80
- Primary Endpoint
- 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)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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
Outcomes
Primary Outcomes
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)
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Study Sites (80)
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