Long-Term Dopamine Transporter Imaging and Clinical Assessment of Parkinson's Disease Progression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Institute for Neurodegenerative Disorders.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00134784
First received: August 23, 2005
Last updated: January 16, 2008
Last verified: January 2008
  Purpose

The purpose of this project is to assess the change in dopamine transporter density in Parkinson's disease subjects during a sixty month period including a nine month treatment trial of levodopa. Dopamine transporter will be assessed using [123I]ß-CIT SPECT (single photon emission computed tomography) imaging, a marker of dopamine terminal integrity and of clinical disease state.


Condition Intervention Phase
Parkinson's Disease
Procedure: [123I]ß CIT and SPECT imaging
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: [123I]ß-CIT and SPECT in Vivo Three Year Imaging Assessment of Dopamine Transporter Density in Subjects With Early Parkinson's Disease Participating in Earlier vs. Later Levodopa in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:
  • To assess the rate of change in striatal [123I]ß-CIT uptake in a cohort of early Parkinson's disease patients

Secondary Outcome Measures:
  • To assess the effect of levodopa treatment on the rate of change in striatal [123I]ß-CIT uptake in a cohort of early Parkinson's disease patients
  • To determine whether the rate of reduction in [123I]ß-CIT uptake in sequential SPECT imaging during a sixty month interval will correlate with the dopamine transporter density measured in the first scan
  • To determine whether the rate of reduction in [123I]ß-CIT uptake in sequential SPECT imaging during a sixty month interval will correlate with changes in the clinical measures of severity of disease
  • To determine cognitive changes in Parkinson's disease and correlate those changes with objective imaging measures of dopaminergic degeneration

Estimated Enrollment: 150
Study Start Date: April 2000
Detailed Description:

All subjects will be imaged at the Institute for Neurodegenerative Disorders.

Subjects will be evaluated sequentially with [123I] ß-CIT SPECT and standardized clinical rating scales during a sixty month period. The subjects involved in this study will have had [123I]ß-CIT and SPECT scans at baseline, nine, eighteen and thirty-six months following the start of their participation in the ELLDOPA study. In this extension study the subjects will receive two additional scans, at forty-eight months and at sixty months following the start of their participation in the ELLDOPA study.

Before each SPECT procedure subjects will be tested to ensure eligibility for the study. They will also have a neurological evaluation including tests of motor function, thinking, memory and handwriting. Some of these tests will be given with the aid of a computer.

On the first day participants are injected with [123I]ß CIT, an investigational radioactive material that localizes in the brain. Study participants will also have a thorough neurologic examination and standard neuropsychological testing, including testing of memory, concentration, abstraction and visual spatial functions.

Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure will be used to obtain SPECT (single photon emission computed tomography) images of the brain.

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prior participation in the study titled Dopamine Transporter Imaging Assessment of Parkinson's Disease Progression (DAMD17-99-1-9472) [123I] B-CIT and Spect in Vivo Imaging Assessment of Dopamine Transporter Density in Subjects With Early Parkinson's Disease Participating in Earlier Vs. Later Levodopa in Parkinson's Disease (ELLDOPA)].

Exclusion Criteria:

  • Inability to sign informed consent and participate in all study procedures.
  • Mini mental status exam < 25.
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134784

Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Investigators
Principal Investigator: Kenneth L Marek, MD Institute for Neurodegenerative Disorders
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00134784     History of Changes
Other Study ID Numbers: Elldopa
Study First Received: August 23, 2005
Last Updated: January 16, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Institute for Neurodegenerative Disorders:
parkinson
brain imaging

Additional relevant MeSH terms:
Parkinson Disease
Disease Progression
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Disease Attributes
Pathologic Processes
Dopamine
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on July 31, 2014