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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Avid Radiopharmaceuticals
• Collaborators: American College of Radiology Imaging Network; General Electric

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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