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NCT02281474 · ClinicalTrials.gov registry record · Phase 1
Nilotinib in Cognitively Impaired Parkinson Disease Patients 001
A Phase 1 study, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT02281474: Completed Phase 1 study, sponsored by Georgetown University.
NCT02281474 is a Phase 1 study that has completed, run by Georgetown University. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02281474, a Phase 1 study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This pilot study will test Nilotinib's ability to alter the abnormal protein build up in Parkinson disease and Diffuse Lewey Body Disease patients . Patients will receive Nilotinib at different doses for 6 months. Patients will then be tested to see if there is change in three areas: 1) has the disease symptoms changed. 2) has levels of a specific misfolded protein changed in the fluid around their brain and spine. 3) Have inflammatory markers changed in the patient's blood and fluid around their brain and spine. If successful, this drug could be used to slow down or stop the progression of disorders that involve abnormal collection of misfolded proteins. However, the main purpose of this pilot study is to check for the safety of using this medication at this level.
Primary Outcome
Working Hypothesis: PD patients have been shown to have elevated levels of α-synuclein in their CSF. Nilotinib has been shown to reduce α-synuclein and Tau in the gastrointestinal tract and central nervous system in animal models, and similarly, we propose will show changes in CSF and serum α-synuclein concentrations in nilotinib treated PD patients.
Interventions
- DRUG Nilotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2014-11 |
| Phase | Phase 1 |
What the finished NCT02281474 record still lists
NCT02281474 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Nilotinib is the first listed.
NCT02281474 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02281474 about?
NCT02281474 is a clinical study titled "Nilotinib in Cognitively Impaired Parkinson Disease Patients 001". This pilot study will test Nilotinib's ability to alter the abnormal protein build up in Parkinson disease and Diffuse Lewey Body Disease patients . Patients will receive Nilotinib at different doses for 6 months. Patients will then be tested to see if there is change in three areas: 1) has the dise...
What is the current status of trial NCT02281474?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2014-11.
What interventions are being tested in trial NCT02281474?
The interventions under investigation include: Nilotinib (DRUG).
Who is sponsoring clinical trial NCT02281474?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02281474's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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