Evaluation of 5-[123I]-A-85380 and SPECT Imaging in Individuals With Parkinsons Disease

April 16, 2014 updated by: Danna Jennings, MD, Institute for Neurodegenerative Disorders

Evaluation of 5-[123I]-A-85380 and SPECT Imaging as a Marker of Nicotinic Receptor Density in the Brain of Parkinson Disease Subjects

The underlying goal of this study is to assess [123I] 5-IA and SPECT imaging as a tool to detect nicotinic receptor activity in the brain of PD patients. All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. Approximately 10 patients with a diagnosis of PD without cognitive changes will be recruited to participate in this study. Patients will be eligible to participate if they have a diagnosis of PD of more than 2 years duration and have no significant cognitive changes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations using the MMSE, the ANAM computerized cognitive battery, and other tests of executive function. All subjects will be evaluated with United Parkinson Disease Rating Scales (UPDRS) following an overnight withdrawal of anti-parkinson medication. Subjects will be asked to undergo an injection of [123I] 5-IA followed by SPECT imaging as described below. A second [123I] 5-IA and SPECT imaging study will be obtained for reliability testing between 2 weeks and 2 months following the initial [123I] 5IA imaging session.

The primary imaging outcome measure will be VT', the equilibrium distribution volume in brain regions is determined from an MRI-directed region-of-interest (ROI) analysis. The baseline imaging VT' will be compared to the follow-up imaging study to the reliability of the nicotinic [123I] 5-IA imaging.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

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
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Institute for Neurodegenerative Disorders

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The presence of idiopathic Parkinson disease
  • A clear clinical response to dopaminergic therapy treatment
  • Hoehn and Yahr Stages < 3;
  • 2-7 year Duration from time of diagnosis.
  • Mini-mental status exam score of >24,
  • For females, non-child bearing potential or negative urine pregnancy test on day of [123I] 5-IA injection.

Exclusion Criteria:

  • Secondary Parkinsonism;
  • Nicotine dependence or use within the previous 12 months prior to enrollment;
  • Treatment with Aricept (donepezil), Exelon (rivastigmine), Cognex (tacrine) within the past 30 days; treatment with medications that bind to the nicotinic receptor.
  • Clinically significant clinical laboratory value and/or medical or psychiatric illness;
  • Mini-mental status exam score of ≤24.
  • The subject has evidence of clinically significant thyroid disease, gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other medical or psychiatric disorder;
  • The subject has received an investigational drug within 30 days of the screening visit;
  • Pregnancy

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [123I] 5-IA
To assess [123I] 5IA and SPECT imaging
Drug: [123I] 5-IA
All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations using the MMSE, the ANAM computerized cognitive battery, and other tests of executive function. All subjects will be evaluated with United Parkinson Disease Rating Scales (UPDRS) following an overnight withdrawal of anti-parkinson medication. Subjects will be asked to undergo an injection of [123I] 5-IA followed by SPECT imaging as described below. A second [123I] 5-IA and SPECT imaging study will be obtained for reliability testing between 2 weeks and 2 months following the initial [123I] 5IA imaging session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiotracer uptake in cortical regions in PD relative to Healthy Control subjects
Time Frame: 2 years
Does [123I] 5-IA demonstrate qualitatively decreased radiotracer uptake in cortical regions consistent with a reduction in nicotinic receptor density in PD patients relative to controls?
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nicotinic receptor as a reliable measure
Time Frame: 2 years
Is [123I] 5-IA a reliable measure of nicotinic receptors in Parkinson Disease?
2 years

Collaborators and Investigators

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

Sponsor

Institute for Neurodegenerative Disorders

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: John Seibyl, MD, Institute for Neurodegenerative Disorders

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2006

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 7, 2006

First Submitted That Met QC Criteria

November 7, 2006

First Posted (Estimate)

November 9, 2006

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5-IA02

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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