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.

Pfizer40 sites in 1 country63 target enrollmentFebruary 2011

ConditionsAlzheimer's Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: Pfizer
Enrollment: 63
Locations: 40
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)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

February 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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.