Phase 2 N=28 Single-blind Diagnostic

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

Alzheimer's Disease

Bottom Line

View on ClinicalTrials.gov: NCT00855868 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2012

Primary outcome: Primary: 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. — 1.33; 1.00; 1.38; 1.06 SUVR

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: florbetapir F 18 (Drug); [11C]-PIB (Drug)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: Avid Radiopharmaceuticals
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	1.33; 1.00; 1.38; 1.06	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00855868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.