Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease

Phase 2

Completed

• Conditions: Alzheimer's Disease

• 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

Study Timeline

• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2010-10-22
• Study First Posted: 2010-10-25
• Study Start: 2011-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Results First Submitted: 2015-02-09
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-28
• Last Update Submitted: 2016-01-28
• Results First Posted: 2016-02-25
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 = 0.5.
• 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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.

Trial Locations

Locations (40)

Banner Alzheimer's Institute; 🇺🇸 Phoenix, Arizona, United States

Banner Good Samaritan Medical Center; 🇺🇸 Phoenix, Arizona, United States

Banner Boswell Medical Center; 🇺🇸 Sun City, Arizona, United States

Banner Lakes Imaging Center; 🇺🇸 Sun City, Arizona, United States

Banner Sun Health Research Institute; 🇺🇸 Sun City, Arizona, United States

Southwest PET Institute; 🇺🇸 Tucson, Arizona, United States

University of Arizona, Health Sciences Center - Department of Neurology; 🇺🇸 Tucson, Arizona, United States

Universal Medical Center; 🇺🇸 Tucson, Arizona, United States

Northwest NeuroSpecialists, LLC; 🇺🇸 Tucson, Arizona, United States

Radiology Limited; 🇺🇸 Tucson, Arizona, United States

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