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Tyrosine Kinase Inhibitor

TKIs for Dementia

Phase 1

Waitlist Available

Led By Sheldon Jordan, MD

Research Sponsored by Neurological Associates of West Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cognitive decline with mild cognitive impairment (Clinical Dementia Rating Stage 0.5) through moderate dementia (CDR Stages 1 and 2)

Be older than 18 years old

Must not have

Advanced stages of any terminal illness or any active cancer that requires chemotherapy

Subjects with contraindications for lumbar puncture, such as bleeding abnormalities, use of anticoagulant medications, and local skin or spine abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is designed to evaluate the tolerability and potential efficacy of tyrosine kinase inhibitors in patients with mild cognitive impairment or dementia. Baseline and outcome measures utilize validated tests that are appropriate for repeated measures. 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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of bosutinib include allergic reactions for those sensitive to it. As doses increase from 100 mg up to 300 mg daily if tolerated, monitoring will be done using CTCAE Version 5.0 guidelines; dose adjustments may occur based on severity of any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have mild to moderate memory or thinking problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an advanced terminal illness or cancer needing chemotherapy.

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

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I have liver problems.

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I have had blood clots in my heart, brain, or limbs.

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I have kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Side effects data

From 2014 Phase 2 trial • 36 Patients • NCT01331291

73%

lymphocyte count decreased

55%

fatigue

45%

nausea

45%

elevated alanine aminotransferase

36%

seizure

36%

hypophosphatemia

36%

maculo-papular rash

27%

diarrhea

27%

rash

18%

lung infection

18%

elevated aspartate aminotransferase

fall

dizziness

vomiting

headache

cerebral edema

cellulitis

100%

80%

60%

40%

20%

Study treatment Arm

Combined Arms

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bosutinib

FDA approved

0 / 6Eligibility criteria met