Assessing Imaging as a Tool in Monitoring and Predicting the Progression of Parkinson Disease

July 1, 2022 updated by: Institute for Neurodegenerative Disorders

Assessing the Determinants of PD Progression - Long-term Dopamine Transporter Imaging in the PRECEPT Cohort

The purpose of this study is to investigate the utility of dopamine transporter imaging in monitoring and predicting the progression of Parkinson disease. This study will be performed in the PRECEPT cohort, an already existing cohort of 806 subjects recruited to participate in the study called, A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of CEP-1347 in Patients With Early Parkinson's Disease - (PRECEPT), sponsored by Cephalon and Lundbeck and coordinated by the Parkinson Study Group. The imaging data from this long-term PRECEPT follow-up study will allow us to evaluate the long-term progression of DAT loss in PD, the long-term follow-up of SWEDD subjects, the relationship between long-term clinical and imaging PD outcomes, and the relationship between long-term imaging outcomes and genetic and biochemical biomarkers of PD progression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The 800 early PD subjects in this study have already been evaluated clinically and have undergone longitudinal dopamine transporter (DAT) imaging with [123I] ß-CIT (baseline and 22 months). In Follow-up imaging will be performed at 24-month intervals (46 and 70 months following PRECEPT baseline). All scanning procedures will be performed at the Institute for Neurodegenerative Disorders (IND) using methods previously employed in the PRECEPT study.

Subjects willing to participate will travel to New Haven for their 46-month imaging visit. At IND a study coordinator and a neurologist will evaluate all subjects. The coordinator and neurologist will discuss the study procedures and evaluate the patient for eligibility. Written informed consent for the study will be obtained prior to performing any study-related procedures.

If eligible, participants will be injected with ß-CIT and 24 hours later an imaging procedure will be used to obtain pictures of brain activity using single photon emission computed tomography (SPECT). This 2-day procedure will be repeated at 70 months (following PRECEPT baseline).

Study Type

Interventional

Enrollment (Actual)

396

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

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject was a participant in the PRECEPT clinical and imaging study
  • Participant must be willing and able to comply with study procedures
  • Participant must be willing and able to give informed consent.

Exclusion Criteria:

  • The participant has a clinically significant clinical laboratory value and/or medical or psychiatric illness
  • The participant has dementia (MMSE≤24)
  • 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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B-CIT and SPECT imaging
To assess B-CIT injection and SPECT scanning. Optional ongoing B-CIT SPECT imaging scans at follow-up visits
Drug: B-CIT and SPECT imaging
Optional ongoing B-CIT SPECT imaging scans at follow-up visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess progression of DAT loss during a 70 month interval
Time Frame: 70 months
70 months

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

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.

Helpful Links

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)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

November 22, 2006

First Submitted That Met QC Criteria

November 24, 2006

First Posted (Estimate)

November 27, 2006

Study Record Updates

Last Update Posted (Actual)

July 5, 2022

Last Update Submitted That Met QC Criteria

July 1, 2022

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRECEPT (Other Identifier: Providence health & Services)

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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