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Study for the Use of TKIs for Treatment of Cognitive Decline Due to Degenerative Dementias

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ClinicalTrials.gov Identifier: NCT02921477
Recruitment Status : Enrolling by invitation
First Posted : October 3, 2016
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Sheldon Jordan, Neurological Associates of West Los Angeles

Brief 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 20 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 4.0 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.


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Dementia Drug: bosutinib Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study for the Use of Tyrosine Kinase Inhibitors for Treatment of Cognitive Decline Due to Degenerative Dementias
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
Drug Information available for: Bosutinib

Arm Intervention/treatment
Experimental: Bosutinib Treatment Arm
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.
Drug: bosutinib
Other Names:
  • bosulif
  • TKI




Primary Outcome Measures :
  1. Number of patients who are discontinued due to tolerability issues related to treatment [ Time Frame: 1 year ]
    Outcome goal to determine safety and tolerability of study medication



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects with a history of hypersensitivity to bosutinib
  • Subjects with contraindications for lumbar puncture, such as bleeding abnormalities, use of anticoagulant medications, and local skin or spine abnormalities
  • Reversible causes of cognitive impairment that explains the clinical status entirely, such as hypothyroidism, depression
  • Advanced stages of any terminal illness or any active cancer that requires chemotherapy
  • Pre-existing renal impairment
  • Pre-existing hepatic impairment
  • QT prolongation
  • Significant cytopenia
  • Cardiovascular, cerebrovascular, and peripheral vascular arterial thrombosis
  • Women who are pregnant, may become pregnant, or are breastfeeding
  • Women of child-bearing potential and male participants with female partners who are of child-bearing potential
  • Subjects unable to give informed consent or in vulnerable categories, such as prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02921477


Locations
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United States, California
Neurological Associates of West LA
Santa Monica, California, United States, 90403
Sponsors and Collaborators
Neurological Associates of West Los Angeles
Pfizer
Investigators
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Principal Investigator: Sheldon Jordan, MD Neurological Associates of West Los Angeles

Publications:

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Responsible Party: Sheldon Jordan, Neurologist, Neurological Associates of West Los Angeles
ClinicalTrials.gov Identifier: NCT02921477     History of Changes
Other Study ID Numbers: 062016
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sheldon Jordan, Neurological Associates of West Los Angeles:
tyrosine kinase inhibitor
bosutinib
bosulif
Additional relevant MeSH terms:
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Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders