Skip to main content
OpenTrials
Completed

NCT Number: NCT00404170

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Disease Attributes Disease Progression Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

B-CIT and SPECT imaging

Drug

Optional ongoing B-CIT SPECT imaging scans at follow-up visits

Primary outcomes

  1. Assess progression of DAT loss during a 70 month interval

    Time frame: 70 months

Sponsors and collaborators

Lead sponsor

Institute for Neurodegenerative Disorders

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2014
Study completion
2014
First posted
Nov 27, 2006
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.