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Remote Cognitive Assessment and Metformin for Brain Tumor Patients

This study is looking at whether patients who have had or are currently receiving radiation to the brain (cranial radiation) can have their care monitored remotely. It also compares outcomes for patients who take metformin (a medication) versus those who don't. Cranial radiation can sometimes affect your thinking, learning, and memory (cognitive function). Researchers want to see if using wearable devices and remote cognitive tests is practical. You might be eligible if you are 18 or older and have a brain tumor requiring or having received cranial radiation within the last 5 years. The main goal is to see how well patients complete the remote cognitive tests over 6 months.

Study design
This interventional study plans to enroll 100 participants. Participants will be randomly assigned to one of two groups: one receiving metformin and the other not.
What's involved
Participants will wear a wearable device, undergo neurocognitive tests, and complete questionnaires. Those in Group A will take metformin by mouth twice a day for 12 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for cognitive assessments is measured at baseline, 3 months, and 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06377696

Remote Cognitive Assessment and Wearable Device While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy

Recruiting
PHASE2Ages 18+InterventionalSupportive care
Mayo Clinic
~100 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Best PracticeMedical Device Usage and EvaluationMetforminNeurocognitive AssessmentQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compliance of patients who complete the testing schedule for the cognitive assessments (Feasibility)
Measured over Baseline, 3 months, and 6 months

Conditions

Malignant Brain Neoplasm

Explore related trials

Malignant Brain Neoplasm

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Ugur T. Sener, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years
Diagnosis of brain tumor requiring cranial radiation treatment NOTE: Patient may be enrolled during or up to 5 years after completion of cranial radiation administered for treatment of primary or metastatic intracranial tumor
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, AND Karnofsky performance status (KPS) of ≥ 70
Expected survival ≥ 6 months in the opinion of treatment team
Willing and able to adhere with the protocol for the duration of the study including undergoing treatment, and attending scheduled visits, and examinations
The following laboratory values obtained ≤ 30 days prior to registration:
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN \[≤ 5 x upper limit normal (ULN) for patients with baseline liver disease\]
Negative pregnancy test ≤ 8 days prior to registration for persons of childbearing potential only
Ability to complete cognitive assessments and questionnaires by themselves or with assistance

Exclusion

Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings
Pregnant or nursing, imprisoned, or lacking capacity for understanding
Unable to swallow tablets or at risk for impaired absorption of oral medication
Currently taking the study agent (i.e., metformin), and cannot safely discontinue if randomized to the control group (Group B)
Known hypersensitivity or allergy to metformin
Current use of resveratrol, CoQ10 (coenzyme Q10), coconut oil/other medium chain triglyceride-containing (e.g., Axona) supplements, or curcumin and unwilling to discontinue prior to registration and remain off these agents for study duration
Unable to read and speak English. Note: English doses not to need to be primary language

What this trial measures

  • Compliance of patients who complete the testing schedule for the cognitive assessments (Feasibility)Baseline, 3 months, and 6 months

    Feasibility will be assessed based on compliance of patients to the testing schedule for the cognitive assessments using the Mayo Test Drive tool.