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

NCT00594633 | Completed Phase 1

• 1 other identifier: 04-122
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor; Brain Cancer; Cns Cancer; Cognitive Dysfunction

Keywords

Cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  conclusion of study

Secondary Outcomes (2)

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

  conclusion of study

• The study will also explore the possibility that the possession of the apolipoprotein E (APOE) є-4 allele is associated with the development of cognitive difficulties following cranial radiation and/or chemotherapy treatments.

  conclusion of study

Study Arms (1)

1

EXPERIMENTAL

donepezil and questionaires

Other: donepezil and questionaires

Interventions

donepezil and questionaires OTHER

Patients will undergo a brief cognitive evaluation prior to (baseline/Time 1), Cognitive Re-Evaluation (about 12 weeks after Time 1), Cognitive Re-Evaluation (about 12 weeks after Time 2) ,Cognitive Re-Evaluation (about 6 months after discontinuation of Donepezil). Then pt will be tx with donepezil, an acetylcholinesterase inhibitor. They will undergo a four-week dose titration (i.e., 5mg QD during weeks 1-4) to reach a final dose of 10mg QD of oral donepezil there after for a maximum of 24 weeks.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Brain Neoplasms; Central Nervous System Neoplasms; Cognitive Dysfunction

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Denise Correa, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: October 1, 2004
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

US (1)