This phase III trial evaluates whether a formulation of memantine hydrochloride and donepezil hydrochloride called Namzaric improves cognitive function in cancer survivors who have received prior standard of care radiation therapy to the brain. Radiation therapy to the brain may lead to decreased cognitive function and health related quality of life. Memantine hydrochloride is a drug that blocks the uptake of calcium by certain types of brain cells, decreasing their activity and improving cognitive function. Donepezil hydrochloride increases the activity of a signaling molecule in the brain called acetylcholine, improving cognitive function. Namzaric may improve cognitive function and health related quality of life in patients who received brain radiation therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04567251.
PRIMARY OBJECTIVES:
I. Assess the effect of Namzaric on the change between baseline and 15 weeks in normalized scores for cognition among cancer survivors who received brain irradiation.
II. Assess the feasibility of using a digital symptom tracking application focused on health-related quality of life and cognition in cancer survivors who received brain irradiation.
EXPLORATORY OBJECTIVES:
I. Assess longitudinally the effect of Namzaric on patient reported outcomes (PROs) as reported in the clinic, including measures of health-related quality of life, cognition, and financial toxicity.
II. Evaluate the safety and tolerability of administering Namzaric to cancer survivors who have received prior irradiation.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive memantine hydrochloride and donepezil hydrochloride (Namzaric) orally (PO) once daily (QD) for 17 weeks.
ARM II: Patients receive placebo PO QD for 17 weeks.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationDuke University Medical Center
Principal InvestigatorKatherine Barnett Peters