Adjunctive Donepezil Therapy and Genetic Risk Factors of Cognitive Dysfunction in Brain Tumor Survivors

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Brief Title

Adjunctive Donepezil Therapy and Genetic Risk Factors of Cognitive Dysfunction in Brain Tumor Survivors

Official Title

Adjunctive Donepezil Therapy and Genetic Risk Factors of Cognitive Dysfunction in Brain Tumor Survivors

Brief Summary

      A significant number of brain tumor patients who received radiation or chemotherapy have
      thinking problems as a result of their treatment. The purpose of this study is to find out if
      treatment with Aricept (donepezil) may improve some aspects of thinking abilities in patients
      with brain tumors who received radiation or chemotherapy. This research will also study
      whether persons having particular genes for a blood-borne substance called apolipoprotein E
      (APOE) are more likely to have thinking problems after radiation or chemotherapy treatment
      for their brain tumors. The findings of this study will help us find out whether Aricept can
      improve thinking abilities after cancer treatment, and whether some of the thinking
      difficulties may be in part related to having certain genes.
    

Detailed Description

      A significant proportion of brain tumor patients treated with radiation or chemotherapy who
      are in disease remission experience cognitive sequelae from their treatment. Cognitive
      dysfunction can be of sufficient severity to interfere with their ability to function at
      premorbid professional and social levels. There are, however, no approved pharmacological
      interventions for improving cognitive functions in cancer patients who display
      treatment-related cognitive deficits. Donepezil, an acetylcholinesterase inhibitor, has been
      shown to provide cognitive and functional benefits in patients with Alzheimer's disease,
      vascular dementia, and in patients with other neurological diseases without known cholinergic
      deficiency. The proposed pilot study will examine the efficacy of donepezil in improving
      cognitive functions in adult brain tumor patients treated with radiation and/or chemotherapy
      who have mild to moderate cognitive difficulties. Neuropsychological measures of executive,
      psychomotor speed, attention, and memory abilities will be administered prior to, during and
      following donepezil therapy. The proposed study will also test the hypothesis that the
      apolipoprotein E (APOE) e-4 allele correlates with the development of cognitive impairment
      after radiation or chemotherapy treatments. The proposed investigation is unprecedented and
      may provide preliminary information about (1) a pharmacological therapy that could improve
      cognitive functions in this population, and (2) a genetic risk factor that may increase
      vulnerability to radiation or chemotherapy-induced cognitive decline.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

The primary goal of this study is to assess the efficacy of donepezil in improving executive abilities and psychomotor speed in adult brain tumor patients who have undergone cranial irradiation and/or chemotherapy.

Secondary Outcome

 This study will also assess the efficacy of donepezil in improving other cognitive domains such as attention, memory, and general cognition in this population.

Condition

Brain Tumor

Intervention

donepezil and questionaires

Study Arms / Comparison Groups

 1
Description:  donepezil and questionaires

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

25

Start Date

October 2004

Completion Date

January 2016

Primary Completion Date

January 2016

Eligibility Criteria

        Inclusion Criteria:

          -  diagnosed with a brain tumor and treated with cranial irradiation and/or chemotherapy,
             and in stable remission of their disease at the time of enrollment.

          -  completed radiation and/or chemotherapy treatment at least 6 months prior to being
             enrolled in the study.

          -  who obtain a Mini-Mental Status Examination (MMSE) score ranging from 18 to 28 at the
             time of enrollment.

          -  are at least 18 years of age.

          -  are English speaking.

          -  have capacity to give consent

        Exclusion Criteria:

          -  Patients with active or progressive disease on recent MRI of the brain either at the
             time of enrollment, or during the study period.

          -  with a pre-existing uncontrolled seizure disorder, or significant renal or hepatic
             impairment.

          -  taking the following medications: antipsychotics, psychostimulants.

          -  patients who have been on selective serotonin re-uptake inhibitors (SSRIs) for less
             than 3 months at the time of enrollment.

          -  with uncontrolled behavioral or mood disturbances.

          -  have their anticonvulsant medication(s) or dosage(s) changed less than 30 days prior
             to enrollment.

          -  currently receiving donepezil or other cholinesterase inhibitors.

          -  who is pregnant.

          -  unable to cooperate or complete cognitive tests.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Denise Correa, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00594633

Organization ID

04-122


Responsible Party

Sponsor

Study Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

 Weill Medical College of Cornell University

Study Sponsor

Denise Correa, PhD, Principal Investigator, Memorial Sloan Kettering Cancer Center


Verification Date

January 2016