TKIs for Dementia

Recruiting in Palo Alto (17 mi)

Dr. Sheldon Jordan | Neurologist | Los ...

Overseen bySheldon Jordan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Neurological Associates of West Los Angeles

No Placebo Group

Trial Summary

What is the purpose of this trial?The present study is designed as an open label study of patients with mild cognitive impairment or dementia to evaluate longer term tolerability and potential efficacy of tyrosine kinase inhibitors. Baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures which are not affected by practice effects. Advantages of this study include the fact that the neuropsychological testing instruments and advanced MRI imaging protocols that have been in routine clinical deployment provide for a high degree of availability and reliability for diagnosis and for monitoring change of status. Quality assurance is tightly controlled. The study population is sufficiently broad and the conditions of interest are sufficiently prevalent so that recruitment of the projected numbers of subjects is not a limiting factor. For a Phase I trial there is a proposed 150 patient sample to determine the frequency of common side effects in the population that is being studied. Subjects will be administered the initial dose of bosutinib, with dosage progressively increased over the course of the study. The initial dose of bosutinib is 100 mg tablet, once per day. The dose will be increased as tolerated up to 300 mg per day. All subjects will be started at 100 mg/day and the dose will be increased by 100 mg each month if the lower dose is tolerated without significant side effects. That is to say, the subject will take 100 mg/day every day for the first month, 200 mg/day every day for the second month, and 300 mg/day every day for the third month and for the remainder of the study, provided that adverse reactions do not prohibit continuation at this dosage. The investigators will be using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 to monitor, evaluate, and report adverse reactions on an ongoing basis. Stopping and dose reduction rules for reported adverse reactions have been taken from the package insert of bosutinib.

Eligibility Criteria

This trial is for people with mild to moderate dementia or cognitive decline, who can handle a lumbar puncture and don't have allergies to bosutinib. It's not for those with reversible cognitive issues, severe illnesses like advanced cancer, kidney or liver problems, heart rhythm issues, blood disorders, recent thrombosis, pregnant or breastfeeding women, and those unable to consent.

Inclusion Criteria

I have mild to moderate memory or thinking problems.

Exclusion Criteria

I have an advanced terminal illness or cancer needing chemotherapy.

I cannot have a lumbar puncture due to bleeding issues, medication, or spine problems.

My cognitive issues are not due to reversible causes like thyroid problems or depression.

+9 more

Participant Groups

The study tests the drug bosutinib on patients with dementia. Starting at 100 mg daily and potentially increasing monthly up to 300 mg if tolerated without serious side effects. The goal is to see how well it works over time using brain scans and memory tests that are reliable and widely available.

1Treatment groups

Experimental Treatment

Group I: Bosutinib Treatment ArmExperimental Treatment1 Intervention

Subjects will be administered the initial dose of bosutinib, with dosage progressively increased over the course of the study. The initial dose of bosutinib is 100 mg tablet, once per day. The dose will be increased as tolerated up to 300 mg per day. The dose will be increased by 100 mg each month if the lower dose is tolerated without significant side effects. That is to say, the subject will take 100 mg/day every day for the first month, 200 mg/day every day for the second month, and 300 mg/day every day for the third month and for the remainder of the study, provided that adverse reactions do not prohibit continuation at this dosage. Stopping and dose reduction rules for reported adverse reactions have been taken from the package insert of bosutinib. The duration of treatment is 1 year.