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NCT04002674 · ClinicalTrials.gov registry record · Phase 2
Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Dementia With Lewy Bodies
A Phase 2 study of Dementia With Lewy Bodies, sponsored by Georgetown University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04002674: Recruiting Phase 2 study of Dementia With Lewy Bodies, sponsored by Georgetown University.
NCT04002674 is a Phase 2 study of Dementia With Lewy Bodies that is actively recruiting participants, run by Georgetown University. The registered enrollment target is 60 participants, below the 469-participant average among 22 other Dementia With Lewy Bodies trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04002674, a Phase 2 study of Dementia With Lewy Bodies, is actively recruiting participants, sponsored by Georgetown University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Dementia with Lewy Bodies (DLB) is an alphasynucleinopathy and the second most common form of dementia in the elderly. DLB shares striking neuropathological and clinical similarities with both Parkinson's disease (PD) and Alzheimer's disease (AD). Nilotinib (Tasigna®, AMN107, Novartis, Switzerland) is approved by the FDA and is well tolerated for CML treatment at oral doses of 600-800mg daily. The Investigators propose to perform a phase II randomized, double blinded, placebo controlled study to evaluate the impact of Nilotinib in patients with DLB.
Primary Outcome
The Investigators will determine safety and tolerability using the occurrence of adverse events (AEs) of interest as per Nilotinib Investigator Brochure (IB).
Conditions Studied
Interventions
- DRUG Placebo oral capsule
- DRUG Nilotinib Oral Capsule
Study Locations (1)
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2023-12-30 |
| Phase | Phase 2 |
What NCT04002674 shows while recruiting
NCT04002674 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 469-participant average among 22 other Dementia With Lewy Bodies trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Dementia With Lewy Bodies appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT04002674 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT04002674 about?
NCT04002674 is a clinical study titled "Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Dementia With Lewy Bodies". Dementia with Lewy Bodies (DLB) is an alphasynucleinopathy and the second most common form of dementia in the elderly. DLB shares striking neuropathological and clinical similarities with both Parkinson's disease (PD) and Alzheimer's disease (AD). Nilotinib (Tasigna®, AMN107, Novartis, Switzerland) ...
What is the current status of trial NCT04002674?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2019-07-01. Estimated completion is 2023-12-30.
What conditions does trial NCT04002674 study?
This clinical trial studies the following conditions: Dementia With Lewy Bodies.
What interventions are being tested in trial NCT04002674?
The interventions under investigation include: Placebo oral capsule (DRUG), Nilotinib Oral Capsule (DRUG).
Who is sponsoring clinical trial NCT04002674?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04002674 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dementia With Lewy Bodies
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04002674's enrollment target sits among peer trials
60 16th of 22 higher than 6 of 22 other Dementia With Lewy Bodies trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dementia With Lewy Bodies 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.
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