Imaging and Genetic Biomarkers of Parkinson Disease (PD) Onset and Progression in High-risk Families

April 21, 2014 updated by: Kenneth Marek, MD, Institute for Neurodegenerative Disorders

Assessment of Pre-symptomatic and Symptomatic Patients With Parkinson Disease to Identify and Characterize Genetic and Phenotypic Biomarkers for Disease Onset and Progression.

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by rigidity, bradykinesia, postural instability, and tremor. Clinical decline reflects ongoing degeneration of dopamine-containing neurons. A critical unmet need for clinical research is to improve early detection of these diseases by developing tools to assist with earlier diagnosis. Biomarkers are broadly defined as characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention (Biomarkers Defintions Working Group 2001). Development of reliable biomarkers for PD would dramatically accelerate research on PD etiology, pathophysiology, disease progression and therapeutics. Specific biomarkers may be useful at the onset of neurodegeneration, the onset of disease, and/or to mark disease progression. The biomarkers in this study include brain imaging with a radioactively labelled drug (Beta-CIT), computerized testing of memory, attention, motor speed, judgment and handwriting, and assessments of speech and smell. Subjects may also be asked to provide a blood sample for genetic and biochemical testing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Individuals who agree to participate in this trial will have a complete screening exam by a neurologist at the Institute for Neurodegenerative Disorders (IND) in New Haven, CT. The exam may include blood tests, urine tests and an electrocardiogram (ECG -tracing of the electrical activity of the heart) to determine eligibility for the trial.

Research subjects will participate in a variety of biomarker assessments including brain imaging, which will take place over a period of two days.

On the first day subjects report to IND after a brief exam subjects will receive a standard dose of Lugol's solution (potassium iodide) by mouth to decrease uptake of the radioactive drug into the thyroid gland. Subjects will be given a standard dose of potassium perchlorate if allergic to iodine.

Next subjects will receive the intravenous (IV - into a vein) injection of the Beta-CIT, a radioactive material that localizes in the brain.

On the second day, about 24 hours after the injection, subjects will return to IND for a SPECT scan. The SPECT camera takes a "picture" of the radiation emitted by the Beta-CIT. This procedure will take approximately 30 minutes.

Subjects will be contacted by phone one week following the injection to monitor adverse (bad or harmful) events possibly related to the imaging procedure.

This two-day imaging procedure, comprehensive neurological testing, and blood collection for genetics and biochemical testing may be repeated every 12 to 18 months during the next five years.

Study Type

Interventional

Enrollment (Actual)

62

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:

  • Age >21
  • Previous participation in the Progeni or Core PD clinical study
  • A diagnosis of parkinsonism or a family history of parkinsonism
  • Normal screening laboratory studies including:
  • complete blood count
  • chemistries
  • urinalysis

Exclusion Criteria:

  • Pregnancy
  • Psychiatric disease other than history of depression
  • Significant medical disease including abnormalities on screening biochemical or hematological labs or abnormal ECG.

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]B-CIT
[123I]B-CIT and SPECT imaging
Drug: [123I]B-CIT
Subjects will receive up to 6 mCi of [123I] B-CIT injected intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dopamine transporter density
Time Frame: 4.5 years
The dopamine transporter density in individuals at risk for Parkinsonism due to family history compared to healthy controls.
4.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of the imaging outcome with both clinical outcomes (olfaction, reaction time, handwriting, etc) and biochemical measures
Time Frame: 4.5 years
4.5 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
Molecular NeuroImaging

Investigators

  • Principal Investigator: Kenneth L. Marek, MD, President and Senior Scientist

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

January 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

January 4, 2006

First Submitted That Met QC Criteria

January 4, 2006

First Posted (Estimate)

January 9, 2006

Study Record Updates

Last Update Posted (Estimate)

May 9, 2014

Last Update Submitted That Met QC Criteria

April 21, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROSPECT

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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