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

NCT00855868 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-07-26

Study results available
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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.

Conditions

Interventions

DRUG

florbetapir F 18

370 MBq (10 mCi), intravenous (IV) injection, single dose

DRUG

[11C]-PIB

555 MBq (15 mCi), IV injection, single dose \[11C\]-PIB

Sponsors & Collaborators

  • American College of Radiology Imaging Network

    collaborator NETWORK

  • General Electric

    collaborator INDUSTRY

  • Avid Radiopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Avid Radiopharmaceuticals

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00855868 on ClinicalTrials.gov