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NCT00315250 · ClinicalTrials.gov registry record · Phase 2
Development of Imaging, Clinical and Biochemical Bio-Markers for Parkinson's Disease
A Phase 2 study, sponsored by Institute for Neurodegenerative Disorders.
- Completed
- Registry status
- Phase 2
- Development phase
- 225
- Enrollment target
NCT00315250: Completed Phase 2 study, sponsored by Institute for Neurodegenerative Disorders.
NCT00315250 is a Phase 2 study that has completed, run by Institute for Neurodegenerative Disorders. The registered enrollment target is 225 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00315250, a Phase 2 study, has completed, sponsored by Institute for Neurodegenerative Disorders.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 225 participants
- Enrollment target
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.
Primary Outcome
Assess the sensitivity and specificity of olfaction, upper limb kinematic behavior, cognition, voice, metabolomic, proteomic and gene expression profiling in categorizing Parkinson Syndrome (PS) vs non-PS defined by \>30% age expected loss of \[123I\]B-CIT SPECT uptake.
Interventions
- DRUG [123I]β-CIT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2006-01 |
| Est. Completion | 2010-06 |
| Phase | Phase 2 |
What the finished NCT00315250 record still lists
NCT00315250 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% higher).
The record links to 0 conditions, and to 1 intervention - of which [123I]β-CIT is the first listed.
NCT00315250 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00315250 about?
NCT00315250 is a clinical study titled "Development of Imaging, Clinical and Biochemical Bio-Markers for Parkinson's Disease". 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...
What is the current status of trial NCT00315250?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 225 participants. The study started on 2006-01. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00315250?
The interventions under investigation include: [123I]β-CIT (DRUG).
Who is sponsoring clinical trial NCT00315250?
This trial is sponsored by Institute for Neurodegenerative Disorders, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00315250's enrollment target sits among peer trials
225 267th of 2000 higher than 1,732 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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