Nilotinib for Lewy Body Dementia

Recruiting in Palo Alto (17 mi)

Overseen byFernando L Pagan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Georgetown University

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests if Nilotinib, a cancer drug taken as a pill, can help elderly patients with Dementia with Lewy Bodies by clearing harmful brain proteins. Nilotinib is part of a promising combination of medications shown to be effective against Alzheimer's disease.

Eligibility Criteria

This trial is for adults aged 25-90 with Dementia with Lewy Bodies (DLB), who can consent to study procedures or have a representative do so. They must be medically stable, on ≤800mg Levodopa daily, willing to undergo lumbar puncture, and meet specific clinical criteria for DLB. Excluded are those with renal insufficiency, active infections or cancer history within five years (except certain cases), pregnant/lactating women, liver/pancreatic/cardiac disease sufferers, and those on conflicting medications.

Inclusion Criteria

Written informed consent

Capable of providing informed consent and complying with study procedures. Subjects who are unable to provide consent may use a Legally Authorized Representative (LAR)

Your MDS-UPDRS-III score is between 15 and 40 when you are on your medication, or up to 70 when you are off your medication.

+9 more

Exclusion Criteria

You show signs of other brain conditions besides dementia with Lewy bodies, such as Parkinson's disease, corticobasal degeneration, or multiple system atrophy.

You have a medical condition or abnormal test results that make it unsafe for you to take the experimental drug.

You have a history of HIV, long-lasting hepatitis, or an ongoing infection that is causing health issues.

+13 more

Participant Groups

The trial tests the safety and effects of Nilotinib oral capsules compared to placebo in patients with DLB. It's a phase II study where participants are randomly assigned to receive either the drug or a placebo while researchers monitor its impact on various health markers related to dementia.

2Treatment groups

Active Control

Placebo Group

Group I: 200 mg NilotinibActive Control1 Intervention

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).

Group II: PlaceboPlacebo Group1 Intervention

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).