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

Phase 2

Completed

• Conditions: Alzheimer's Disease

• Registration Number: NCT00855868
• Lead Sponsor: Avid Radiopharmaceuticals

Brief 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.

Detailed Description

15 patients with a clinical diagnosis of probable Alzheimer's disease and 15 cognitively normal elderly control subjects will receive both \[18F\]-AV-45 and \[11C\]PIB to compare the diagnostic performance characteristics of each amyloid ligand to distinguish AD from normal subjects. In addition to clinical diagnostic category, ligand retention will be evaluated with respect to measures of symptom severity and cerebrospinal fluid levels of amyloid and tau.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-03
• Study First Posted: 2009-03-05
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Disposition First Submitted: 2012-03-06
• Disposition First Submitted QC: 2012-03-06
• Disposition First Posted: 2012-03-08
• Results First Submitted: 2012-05-04
• Status Verified: 2012-06
• Results First Submitted QC: 2012-06-19
• Last Update Submitted: 2012-06-19
• Results First Posted: 2012-07-26
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects.	28 d	Standardized Uptake Value ratio (SUVR) as measured in this study indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Philadelphia, Pennsylvania, United States