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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have mild to moderate memory or thinking 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Neurological Associates of West Los AngelesLead Sponsor

25 Previous Clinical Trials

3,810 Total Patients Enrolled

3 Trials studying Dementia

423 Patients Enrolled for Dementia

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,911,724 Total Patients Enrolled

7 Trials studying Dementia

3,078 Patients Enrolled for Dementia

Sheldon Jordan, MDPrincipal InvestigatorNeurological Associates of West Los Angeles

12 Previous Clinical Trials

2,440 Total Patients Enrolled

Media Library

bosutinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02921477 — Phase 1

Dementia Research Study Groups: Bosutinib Treatment Arm

Dementia Clinical Trial 2023: bosutinib Highlights & Side Effects. Trial Name: NCT02921477 — Phase 1

bosutinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02921477 — Phase 1

Frequently Asked Questions

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

Are there any openings for this clinical examination available to individuals at the moment?

"Unfortunately, no more participants can be enrolled in this trial as recruitment has been closed. Initially posted September 1st 2016 and last updated on September 26th 2022, it is now inactive. For individuals seeking alternative trials, there are 880 studies involving dementia that still require enrolment and 11 bosutinib-centered medical research projects currently recruiting patients."

Answered by AI

Is there an eligibility criterion for taking part in this experiment?

"Eligibility for this clinical trial necessitates a dementia diagnosis and falling within the ages of 45 to 89. Approximately 150 candidates are being welcomed into participation."

Answered by AI

Has bosutinib received federal authorization for use?

"Considering the limited clinical data, bosutinib received an estimation of 1 on our safety scale. This Phase 1 trial provides only minimal evidence for efficacy and safety."

Answered by AI

Has this trial previously been conducted in any other form?

"Pfizer first oversaw a trial involving 150 individuals in 2016, leading to the initial phase 1 drug approval for bosutinib. Presently, 11 active trials are running worldwide across 455 cities and 39 nations."

Answered by AI

Is the enrollment for this trial inclusive of individuals older than forty?

"Patients that meet the criteria for this medical trial must be between 45 and 89 years old."

Answered by AI

How many volunteers have been accepted into this clinical trial?

"This trial is no longer accepting applications. It was first posted on September 1st 2016 and last updated on September 26th 2022. For those searching for clinical trials, there are 880 studies looking for dementia patients and 11 bosutinib-related trials actively recruiting participants."

Answered by AI

Recent research and studies

EMBO Molecular MedicineJournal

Tyrosine Kinase Inhibition Increases Functional Parkin‐ <scp>b</scp> Eclin‐1 Interaction and Enhances Amyloid Clearance and Cognitive Performance

Lonskaya, Irina, Michaeline L. Hebron, Nicole M. Desforges, Alexander Franjie, and Charbel E.‐H. Moussa. 2013. “Tyrosine Kinase Inhibition Increases Functional Parkin‐ b Eclin‐1 Interaction and Enhances Amyloid Clearance and Cognitive Performance”. EMBO Molecular Medicine. EMBO. doi:10.1002/emmm.201302771.

NeuropharmacologyJournal

Predictors of Cognitive Decline and Treatment Response in a Clinical Trial on Suspected Prodromal Alzheimer's Disease

Teipel, Stefan J., Enrica Cavedo, Michel J. Grothe, Simone Lista, Samantha Galluzzi, Olivier Colliot, Marie Chupin, et al.. 2016. “Predictors of Cognitive Decline and Treatment Response in a Clinical Trial on Suspected Prodromal Alzheimer's Disease”. Neuropharmacology. Elsevier BV. doi:10.1016/j.neuropharm.2016.02.005.

Psychiatric ServicesJournal

The Hopkins Competency Assessment Test: A Brief Method for Evaluating Patients' Capacity to Give Informed Consent

Janofsky, Jeffrey S., Richard J. McCarthy, and Marshal F. Foistein. 1992. “The Hopkins Competency Assessment Test: A Brief Method for Evaluating Patients' Capacity to Give Informed Consent”. Psychiatric Services. American Psychiatric Association Publishing. doi:10.1176/ps.43.2.132.

Journal of the Neurological SciencesJournal