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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT01227564

Run by

Pfizer

People needed

63

Starts

2011-02-01

Expected to finish

2014-02-01

Last updated by the study team

2016-02-25

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• Pacific Neuroscience Medical Group — Oxnard, California, United States
• GCRC (Drug administered) — New Haven, Connecticut, United States
• Yale University School of Medicine, Alzheimer's Disease Research Unit — New Haven, Connecticut, United States
• Investigational Drug Service — New Haven, Connecticut, United States
• Norman S. Werdiger, MD — New Haven, Connecticut, United States
• Clinical Research Unit — Washington D.C., District of Columbia, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Georgetown University Medical Center Department of Neurology — Washington D.C., District of Columbia, United States
• Meridien Research — Brooksville, Florida, United States
• Florida Neurology Group PL — Fort Myers, Florida, 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
• Florida Radiology Leasing, Limited Liability Corporation — Fort Myers, Florida, United States
• Radiology Regional Center — Fort Myers, Florida, United States
• Miami Jewish Health Systems — Miami, Florida, United States

Full record on ClinicalTrials.gov

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