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Tyrosine Kinase Inhibitor

Nilotinib for Lewy Body Dementia

Phase 2
Recruiting
Led By Fernando L Pagan, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients between the age of 25-90 years, medically stable
Clinical diagnosis of DLB according to McKeith et al (7) with both dementia MoCA≥18 and Parkinsonian defined as bradykinesia in combination with rest tremor, rigidity or both UPDRS I-III is less than 50 and/or UPDRS-III between 15 -40 on-state. Dementia and Parkinsonism must be present with at least one other symptom such as fluctuation, visual hallucinations or REM sleep behavioral disorder (RBD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will evaluate if the drug Nilotinib can improve symptoms in patients with Dementia with Lewy Bodies, a condition that shares similarities with both Parkinson's disease and Alzheimer's disease.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not specified here, common side effects of Nilotinib may include nausea, rash, fatigue, headache, constipation/diarrhea and muscle/joint pain. As it's used at lower doses than for its original purpose (treating leukemia), different side effects might occur in this context.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are between 25 and 90 years old and in good health.
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You have been diagnosed with dementia with Lewy bodies (DLB) and also show signs of Parkinson's disease such as slow movements, tremors, or stiffness. You must also have at least one other symptom like changes in alertness, seeing things that aren't there, or acting out dreams during sleep.
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You are at a specific stage of Parkinson's disease, between stages 2.5 and 3 according to the Hoehn and Yahr scale.
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You have been taking MAO-B inhibitors like Selegeline or rasagiline for at least 4 weeks before the study and during treatment with Nilotinib.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability: occurrence of adverse events (AEs)
Secondary outcome measures
The Investigator will determine Nilotinib levels in CSF and plasma.
The Investigators will determine changes in DLB related CSF and plasma biomarkers
The investigators will quantify amyloid burden via Florbetaben PET scan
Other outcome measures
Measurement of the effects of Nilotinib on Cognition using the Montreal Cognitive Assessment (MoCA)
Measurement of the effects of Nilotinib on Cognition using the Trail Making Test (TMT)
Measuring the effects of NIlotinib on Cognition using the Alzheimer's Disease Assessment Scale - cognitive (ADAS-cog).
+7 more

Trial Design

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).

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
341 Previous Clinical Trials
126,442 Total Patients Enrolled
3 Trials studying Dementia
1,071 Patients Enrolled for Dementia
National Institutes of Health (NIH)NIH
2,679 Previous Clinical Trials
6,910,622 Total Patients Enrolled
21 Trials studying Dementia
10,939 Patients Enrolled for Dementia
Fernando L Pagan, MDPrincipal InvestigatorGeorgetown University
4 Previous Clinical Trials
180 Total Patients Enrolled
2 Trials studying Dementia
71 Patients Enrolled for Dementia

Media Library

Nilotinib Oral Capsule (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04002674 — Phase 2
Dementia Research Study Groups: Placebo, 200 mg Nilotinib
Dementia Clinical Trial 2023: Nilotinib Oral Capsule Highlights & Side Effects. Trial Name: NCT04002674 — Phase 2
Nilotinib Oral Capsule (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04002674 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include elderly individuals as participants?

"The protocol for this study specifies that participants must be aged 25 or older and no more than 90 years old."

Answered by AI

Is there presently an opportunity to join this experiment?

"Affirmative. The information available on clinicaltrials.gov implies that this experiment is presently enrolling volunteers. It was first released on July 1, 2019 and its details were most recently updated on May 2, 2022. A total of 60 participants are being registered at a single site."

Answered by AI

Who qualifies to participate in this medical experiment?

"This medical trial is looking to recruit 60 participants aged between 25 and 90 that have been clinically diagnosed with dementia. The enrolled patients must be able to comprehend the study's procedures, provide informed consent or appoint a Legally Authorized Representative (LAR), demonstrate relatively mild Parkinsonian symptoms according to UPDRS scores of I-III less than 50/UPDRS III 15-40 on state, present one additional symptom such as fluctuation, visual hallucinations or REM sleep behavioral disorder (RBD), possess an abnormal DaTScan result and be medically stable. Furthermore, it is required that those interested in enrolling not take monoamine oxid"

Answered by AI

How does this experiment compare to previous precedents in its field?

"Since 2008, 200 mg Nilotinib has been explored in numerous clinical trials. The inaugural study was funded by Novartis Pharmaceuticals and included 34 participants; the trial concluded with Phase 4 drug approval for this dosage of nitlotinib. At present, 35 disparate experiments are being conducted on its efficacy across 42 nations and 566 cities."

Answered by AI

How many persons have enrolled in this research endeavor?

"Affirmative, according to the information hosted on clinicaltrials.gov this trial is actively recruiting patients. This medical study was initially posted July 1st 2019 and last updated May 2nd 2022; a total of 60 participants are needed across one centre for enrolment."

Answered by AI

Has any research been carried out concerning the efficacy of 200 mg Nilotinib?

"Presently, 35 clinical trials for 200 mg Nilotinib are underway; 6 of them being in the advanced Phase 3 stage. The epicentre for this research appears to be Fukuoka city, with 1548 centres operating studies on the medication globally."

Answered by AI

How much Nilotinib is permissible for therapeutic use without posing a risk?

"Nilotinib has been evaluated in a Phase 2 trial, so our team at Power considered the safety of 200 mg to be moderately safe and scored it as a 2."

Answered by AI
~11 spots leftby Mar 2025