Study for the Use of TKIs for Treatment of Cognitive Decline Due to Degenerative Dementias
Status:
Enrolling by invitation
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
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.