A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

Phase 2

Completed

• Conditions: Alzheimer's Disease; Mild Cognitive Impairment
• Interventions: Drug: florbetapir F 18

• Registration Number: NCT00702143
• Lead Sponsor: Avid Radiopharmaceuticals

Brief Summary

Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-19
• Study First Posted: 2008-06-20
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Disposition First Submitted: 2011-11-21
• Disposition First Submitted QC: 2011-11-21
• Disposition First Posted: 2011-11-23
• Results First Submitted: 2012-04-06
• Results First Submitted QC: 2012-04-06
• Status Verified: 2012-05
• Results First Posted: 2012-05-03
• Last Update Submitted: 2012-05-08
• Last Update Posted: 2012-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

Not provided

Exclusion Criteria

• Have a history or current diagnosis of other neurologic disease
• Have had or currently have a diagnosis of other neurodegenerative disease
• Have participated in experimental therapy targeted to amyloid plaque

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AD subjects	florbetapir F 18	-
MCI Subjects	florbetapir F 18	MCI (mild cognitive impairment)
Healthy controls	florbetapir F 18	-

Primary Outcome Measures

Name	Time	Method
Qualitative Amyloid Image Assessment	50-60 min after injection	Three readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.
Mean Cortical to Cerebellum SUVR	50-60 min after injection	Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.

Secondary Outcome Measures

Name	Time	Method
Proportion of Positive Florbetapir-PET Scans	50-60 min after injection	Three readers blinded to all clinical information classified florbetapir-PET images as either positive for amyloid or negative for amyloid. The majority read was used to determine the proportion of positive scans across the three groups.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Bennington, Vermont, United States