CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled / 43 target
Drug / intervention
Placebo oral capsule +1 moredrug
Likely dose
Nilotinib Oral Capsule 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04002674
NCT04002674Phase 2CompletedOn Track (0.5/mo)Completion was 14mo ago
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A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Nilotinib Treatment on Safety, Tolerability, Pharmacokinetics and Biomarkers in Dementia With Lewy Bodies (DLB)

Georgetown University·interventional·Posted Jun 28, 2019·Updated Jun 12, 2026

In Brief

A Phase 2 clinical trial evaluating Placebo oral capsule and Nilotinib Oral Capsule for Dementia With Lewy Bodies. Completed, enrolled 43 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDementia With Lewy Bodies
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH)

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 28, 2019
Enrollment StartJul 1, 2019
Primary CompletionApr 30, 2025
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 7.0 years ago

Arms & Interventions

Placeboplacebo_comparator

Sixty (60) participants will be recruited and randomized into 2 arms (1:1). Thirty (30) patients in arm 1 will receive the matching placebo ("sugar pill") one (1) capsule orally (without food) once daily for 6 months (180 days).

Drug: Placebo oral capsule
200 mg Nilotinibactive_comparator

Sixty (60) participants will be recruited and randomized into 2 arms (1:1). Thirty (30) patients in arm 2 will receive the 200 mg of Nilotinib one (1) capsule orally (without food) once daily for 6 months (180 days).

Drug: Nilotinib Oral Capsule

Interventions

Placebo oral capsuledrug

Thirty (30) patients in arm 1 will receive the matching placebo ("sugar pill") one (1) capsule orally (without food) once daily for 6 months (180 days).

Nilotinib Oral Capsuledrug

Thirty (30) patients in arm 2 will receive the 200 mg of Nilotinib one (1) capsule orally (without food) once daily for 6 months (180 days).