Development of Imaging, Clinical and Biochemical Bio-Markers for Parkinson's Disease

NCT00315250 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2014-05-09

No results posted yet for this study

Summary

We propose to build on preliminary data evaluating non-dopaminergic/non-motor clinical biomarkers to more fully assess these markers at the threshold of Parkinson disease (PD).

Development of reliable biomarkers for both dopaminergic and non-dopaminergic manifestations of Parkinson disease (PD) and related disorders may dramatically accelerate research on PD etiology, pathophysiology, and therapeutics. 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. Specific biomarkers may be useful at the onset of neurodegeneration, the onset of disease, and/or to mark disease progression.

Conditions

Interventions

DRUG

[123I]β-CIT

Single Photon Emission Computed Tomography SPECT imaging uses the single photon emissions from radioactive compounds that are (most commonly) injected into a patient and are metabolized by specific organs or body systems. SPECT imaging is performed by using a gamma camera to acquire multiple 2-D images (also called projections), from multiple angles. A computer is then used to apply a tomographic reconstruction algorithm to the multiple projections, yielding a 3-D dataset. This dataset may then be manipulated to show thin slices along any chosen axis of the body, similar to those obtained from other tomographic techniques, such as MRI, CT, and PET. The resulting SPECT images reflect body/organ function as opposed to specific anatomy of other imaging modalities such as CT or MRI.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED
  • Molecular NeuroImaging

    collaborator OTHER
  • Institute for Neurodegenerative Disorders

    lead OTHER

Principal Investigators

  • Danna Jennings, MD · Institute for Neurodegenerative Disorders

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2010-01-31
Completion
2010-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00315250 on ClinicalTrials.gov