A Trial of 18F-AV-133 and 18F-AV-45 Positron Emission Tomography (PET)

Phase 1

Completed

• Conditions: Dementia With Lewy Bodies; Alzheimer's Disease; Parkinson's Disease
• Interventions: Drug: 18F-AV-133; Drug: 18F-AV-45

• Registration Number: NCT01503944
• Lead Sponsor: Avid Radiopharmaceuticals

Brief Summary

The purpose of this study is to evaluate the ability to identify individuals with dopaminergic degeneration in group of patients with a clinical diagnosis of either dementia with Lewy bodies (DLB) or idiopathic Parkinson's disease and to differentiate them from Alzheimer's disease (AD) and control subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-07-14
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted QC: 2012-01-02
• Study First Posted: 2012-01-04
• Status Verified: 2012-08
• Disposition First Submitted: 2012-08-03
• Disposition First Submitted QC: 2012-08-03
• Last Update Submitted: 2012-08-03
• Disposition First Posted: 2012-08-14
• Last Update Posted: 2012-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

• Have a history or current diagnosis of other neurologic disease
• Have evidence of clinically significant cerebrovascular disease
• Have evidence from MRI or other biomarker studies that suggests the presence of a CNS pathology other than that associated with the study diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dementia with Lewy Bodies	18F-AV-45	-
Parkinson's disease	18F-AV-45	-
Healthy Elderly Volunteers	18F-AV-45	-
Dementia with Lewy Bodies	18F-AV-133	-
Alzheimer's Disease	18F-AV-45	-
Parkinson's disease	18F-AV-133	-
Healthy Elderly Volunteers	18F-AV-133	-
Alzheimer's Disease	18F-AV-133	-

Primary Outcome Measures

Name	Time	Method
18F-AV-133 striatal to occipital standard uptake value ratio	Four Weeks	The ratio of tracer activity in striatal target areas of interest relative to the occipital cortex reference region

Secondary Outcome Measures

Name	Time	Method
18F-AV-45 cortical to cerebellar standard uptake value ratio	Four Weeks	The ratio of tracer activity in cortical target areas of interest relative to the cerebellum reference region

Trial Locations

Locations (1)

Research Site; 🇺🇸 Philadelphia, Pennsylvania, United States