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RecruitingInterventionalPhase 2

Repurposing Riluzole for Augmenting Brain-Derived Neuropathic Factor (BDNF) Levels and Cognitive Function in Patients Experiencing Cancer-Related Cognitive Impairment: An Interventional Pilot Clinical Trial

NCT ID: NCT06580002Sponsor: University of California, IrvineLast updated: 2025-06-26

Summary

This is a phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining the impact of riluzole therapy on circulating brain derived neuropathic factor (BDNF) levels of cancer survivors with cancer related cognitive impairment.

Arms & interventions

  • DrugRiluzole

    Given PO

  • DrugPlacebo

    Given PO

Outcome measures

Primary

  • Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer survivors experiencing cognitive impairment (CRCI)

    Comparing mean plasma BDNF values at each patient visit point, including before the intervention, at the midpoint, and at the endpoint of the study.

    Time frame: 8 weeks

Secondary

  • Cognitive Function Scores (FACT-Cog)

    Time frame: 8 weeks

  • Cognitive Function Scores (CANTAB)

    Time frame: 8 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Female and male patients diagnosed with one of the following: 1. Breast cancer exposed to treatment including chemotherapy, radiotherapy, surgery and/or other breast cancer interventions 2. Non-breast cancer patients exposed to anthracyclines- or platinum-containing chemotherapy within the past 3 years 3. Non-breast cancer patients exposed to other anticancer therapies within the past 3 years * Washout from investigational interventions is up to the discretion of the Investigator. Concurrent participation in another intervention is allowable if judged by the Principal Investigator that this would not be scientifically or medically incompatible with this study. * ≥18 years of age * Perceived by patient or investigator that cognitive function has worsened since cancer diagnosis and/or beginning of cancer treatment * Able to provide informed consent. * Literacy in English, Chinese, Korean, Vietnamese, or Spanish, to complete the questionnaires. * Patients must agree to complete and be able to complete the questionnaires and computerized assessments used to measure functional outcomes. Note: Patients who have visual impairment or have degenerative conditions (e.g. Parkinsons's disease, etc.) can participate if they cannot complete computerized assessments, as long as they can still complete the questionnaires with assistance. Exclusion Criteria: * Presence of brain metastasis * Unwilling to undergo neuropsychological assessments necessary for the study. * Women who are breastfeeding, pregnant or are planning to get pregnant during the study period. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening if there is suspicion of pregnancy. a. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy. * History of suspected hypersensitivity to riluzole or to any of its excipients. * Patients taking or planned to take medications/substances with potential drug-drug interactions: pixantrone, current smoker (defined as having smoked within the last month), abametapir, cannabis, capmatinib, lapatinib, methotrexate, and levoketoconazole. * Hepatic impairment as indicated by: AST or ALT ≥ 3x upper limit normal (ULN) * Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.

Study locations (1)

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, 92868

Recruiting
Alexandre Chan, PharmD, MPH · Contact