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

August 3, 2012 updated by: Avid Radiopharmaceuticals

Detection of Striatal Dopaminergic Degeneration and Neocortical Amyloid Pathology in Patients With Dementia With Lewy Bodies, Alzheimer's Disease, Parkinson's Disease, and Healthy Elderly Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Sun City, Arizona, United States
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria DLB:

  • Male or female > 50 years of age
  • Meet the diagnostic criteria for probable DLB as established by the DLB Consortium (McKeith et al., 2005)

Inclusion Criteria AD:

  • Male or female > 50 years of age
  • Meet the NINCDS criteria for probable AD and have a Mini Mental State Examination (MMSE) score at screening between 10 and 24 inclusive

Inclusion Criteria PD:

  • Male or female > 50 years of age

  • Have probable PD according to the following criteria (Gelb et al., 1999):

    • Presence of 2 of the following 3 features: rest tremor, rigidity, bradykinesia;
    • Documented history of a sustained (>6 months) improvement to Levodopa (L-DOPA) or a dopamine agonist
    • Absence of atypical clinical features or other possible signs or symptoms suggesting another cause of parkinsonism such as a history of frequent falls as a prominent early feature, localized brain lesion(s) or neuroleptic use
    • Asymmetric onset
  • A diagnosis of PD made within the 4 years prior to enrollment

Normal subjects:

  • Are males or females > 50 years of age
  • Have a MMSE score > 29, and are cognitively normal on the psychometric test battery at screening
  • Have no signs or symptoms of clinically meaningful parkinsonism

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Dementia with Lewy Bodies
Drug: 18F-AV-133
185 MBq
Drug: 18F-AV-45
185-370 MBq
Other: Parkinson's disease
Drug: 18F-AV-133
185 MBq
Drug: 18F-AV-45
185-370 MBq
Other: Healthy Elderly Volunteers
Drug: 18F-AV-133
185 MBq
Drug: 18F-AV-45
185-370 MBq
Other: Alzheimer's Disease
Drug: 18F-AV-133
185 MBq
Drug: 18F-AV-45
185-370 MBq

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avid Radiopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

July 14, 2010

First Submitted That Met QC Criteria

January 2, 2012

First Posted (Estimate)

January 4, 2012

Study Record Updates

Last Update Posted (Estimate)

August 14, 2012

Last Update Submitted That Met QC Criteria

August 3, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18F-AV-133-B03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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