Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals

Completed · Phase 2

Conditions studied: Alzheimer's Disease

In brief

This study will evaluate the performance characteristics of a novel \[18F\] amyloid detection ligand (18F\]-AV-45) with respect to its ability to distinguish patients with clinically-diagnosed probable Alzheimer's disease from cognitively normal elderly subjects and to independently compare its diagnostic performance characteristics with the ability of \[11C\]PIB to correctly categorize the same subjects. SPECIFIC HYPOTHESES 1. Individuals with a clinical diagnosis of probable Alzheimer's disease will have increased brain retention of \[18F\]-AV-45 compared to cognitively normal elderly individuals. 2. There will be no clinically meaningful difference in the amyloid retention performance characteristics of \[18F\]-AV-45 and \[l1C\]PIB.

Key facts

Study ID: NCT00855868
Run by: Avid Radiopharmaceuticals
People needed: 28
Starts: 2009-03-01
Expected to finish: 2011-01-01
Last updated by the study team: 2012-07-26

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Normal subjects: mini-mental state examination (MMSE) 27-30, clinical dementia rating (CDR) = 0, no symptoms of depression
Alzheimer's subjects: MMSE 18-26, CDR >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI

You may not qualify if…

other neurological disease
evidence of MRI abnormality
psychiatric disorder
alcohol abuse
clinically significant lab abnormalities
residence in nursing facility
participation in clinical trial with experimental medication in past 1 month

Where it is running

Research Site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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