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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04002674
The ClinicalTrials.gov registry entry for NCT04002674 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 469-participant average among 22 other Dementia With Lewy Bodies trials with a reported enrollment target (87% lower). The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.