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NCT06377696 · ClinicalTrials.gov registry record · Phase 2
Remote Cognitive Assessment and Wearable Device While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy
A Phase 2 study of Malignant Brain Neoplasm, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06377696: Recruiting Phase 2 study of Malignant Brain Neoplasm, sponsored by Mayo Clinic.
NCT06377696 is a Phase 2 study of Malignant Brain Neoplasm that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 100 participants, below the 221-participant average among 12 other Malignant Brain Neoplasm trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06377696, a Phase 2 study of Malignant Brain Neoplasm, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase III trial evaluates whether patient care can be done remotely for patients having cranial (skull) radiation or who have previously had cranial radiation. In addition, this trial compares study outcomes between patients who get metformin and those who do not. Cranial radiation, an essential component of brain tumor treatment, can result in significant negative effects on cognitive (the ability to clearly think, learn, and remember) function. Wearable devices have been used in the field of neurology for seizure detection and assessment of patients with movement disorders. Wearable device technology has also been implemented for remote monitoring of cancer patients and for cancer clinical trials. Metformin is the active ingredient in a drug used to treat type 2 diabetes mellitus (a condition in which the body cannot control the level of sugar in the blood). It is also being studied in the treatment of cancer. Use of metformin may reduce risk of cognitive decline following radiation therapy within the skull (intracranial). These effects may be further strengthen by addition of device-based physical activity promotion. Mayo Test Drive is a web-based platform for remote self-administered cognitive assessment. Using Mayo Test Drive may help determine whether patient care can be done remotely, while simultaneously evaluating benefits of health promotion through use of a wearable watch device and metformin in preventing radiation-related cognitive decline.
Primary Outcome
Feasibility will be assessed based on compliance of patients to the testing schedule for the cognitive assessments using the Mayo Test Drive tool.
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- OTHER Medical Device Usage and Evaluation
- DRUG Metformin
- OTHER Best Practice
- OTHER Neurocognitive Assessment
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-05-31 |
| Est. Completion | 2027-05-01 |
| Phase | Phase 2 |
What NCT06377696 shows while recruiting
NCT06377696 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 12 other Malignant Brain Neoplasm trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Malignant Brain Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Questionnaire Administration is the first listed.
NCT06377696 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06377696 about?
NCT06377696 is a clinical study titled "Remote Cognitive Assessment and Wearable Device While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy". This phase III trial evaluates whether patient care can be done remotely for patients having cranial (skull) radiation or who have previously had cranial radiation. In addition, this trial compares study outcomes between patients who get metformin and those who do not. Cranial radiation, an essentia...
What is the current status of trial NCT06377696?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2024-05-31. Estimated completion is 2027-05-01.
What conditions does trial NCT06377696 study?
This clinical trial studies the following conditions: Malignant Brain Neoplasm.
What interventions are being tested in trial NCT06377696?
The interventions under investigation include: Questionnaire Administration (OTHER), Medical Device Usage and Evaluation (OTHER), Metformin (DRUG), Best Practice (OTHER), Neurocognitive Assessment (OTHER).
Who is sponsoring clinical trial NCT06377696?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06377696 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06377696's enrollment target sits among peer trials
100 5th of 12 higher than 8 of 12 other Malignant Brain Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Brain Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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