Treatment for Dementia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
MedStar Georgetown University Hospital, Washington, United States
Dementia+2 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether nilotinib may have positive impacts for individuals with dementia with Lewy bodies.

See full description

Eligible Conditions

  • Dementia
  • Dementia With Lewy Body Disease

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome, 3 secondary outcomes, and 10 other outcomes in patients with Dementia. Measurement will happen over the course of 6 Months.

6 Months
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).
Measuring the effects of Nilotinib on Behavior using the Alzheimer's disease Cooperative Study-Activity of Daily Living scale
Measuring the effects of Nilotinib on Behavior using the Clinical Assessment of Fluctuation (CAF)
Measuring the effects of Nilotinib on Behavior using the Irritability-Apathy Scale (IAS)
Measuring the effects of Nilotinib on Behavior using the Neuropsychiatric Inventory (NPI)
Measuring the effects of Nilotinib on Behavior using the Problem Behaviors Assessment short form (PBA-s)
Measuring the effects of Nilotinib on Motor Function by using the Timed-Up-And-Go (TUG).
Measuring the effects of Nilotinib on Motor Function by using the Unified Parkinson's Disease Rating Scale (UPDRS)-I-III.
Safety and tolerability: occurrence of adverse events (AEs)
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

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

200 mg Nilotinib
1 of 2
Placebo
1 of 2
Active Control
Non-Treatment Group

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Placebo
Drug
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).
200 mg Nilotinib
Drug
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).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Who is running the study

Principal Investigator
F. P.
Prof. Fernando Pagan, MD
Georgetown University

Closest Location

MedStar Georgetown University Hospital - Washington, United States

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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).
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)
2.5 ≥Hoehn and Yahr stage ≤3
MDS-UPDRS-III 15-40 on-state (or up to 70 on the off state)
Abnormal DaTScan
Stable concomitant medical and/or psychiatric illnesses in the judgement of the PI
Patients between the age of 25-90 years, medically stable
Must NOT be stable on mono-amine oxidase (MAO)-B inhibitors (Selegeline or rasagiline) for at least 4 weeks before enrollment and during Nilotinib treatment.
Must be medically stable on less than or equal to 800mg Levodopa daily for at least 4 weeks

Patient Q&A Section

Ask a question about the study

Other questions from users

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

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Dementia by sharing your contact details with the study coordinator.