Trial · NCT06377696
Remote Cognitive Assessment and Wearable Device While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy
NCT06377696, Phase 2, Active not recruiting, Mayo Clinic
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Remote Cognitive Assessment and Wearable Device While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy. Trials, record NCT06377696. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06377696
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Remote Cognitive Assessment and Wearable Device While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy
- NCT number
- NCT06377696
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Malignant Brain Neoplasm
- Interventions
- Best Practice, Medical Device Usage and Evaluation, Metformin, Neurocognitive Assessment, Questionnaire Administration
- First posted
- 2024-04-22
- Last updated
- 2026-10-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Secondary | Overall completion rates and compliance (Feasibility) | Up to 12 months | Will evaluate compliance of completing the patient-reported symptom assessments and the activity and sleep assessments and will assess for any patterns within and between the treatment arms. |
| Secondary | Overall satisfaction | Up to 12 months | Satisfaction/acceptance rates will be evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C-30, which consists of 30 questions, each answered on a 4-point (e.g., not at all, a little, quite a bit, very much) or a scale of 1-7 where 1=very poor and 7=excellent. |
| Secondary | Adherence (Feasibility) | Up to 12 months | Adherence to study drug will be evaluated in those randomized to the metformin treatment group. Will consider sufficient adherence to be defined as taking at least 80% of the prescribed doses. |
| Secondary | Neurocognitive scores | Up to 12 months | Neurocognitive scores will be assessed using the Mayo Test Drive, a web-based platform for remote self-administered cognitive assessment that uses the Stricker Learning Span (SLS), which is a computer adaptive word-list memory test that matches test difficulty to user performance, and the Symbols test, which is a measure of processing speed and executive functioning that requires timed visual matching. The primary outcome measure will be the Mayo Test Drive raw composite (range 0 - 158). Higher scores indicate better cognitive test performance. Several secondary outcome measures will also be analyzed including but not limited to SLS sum of trials (0-108), an accuracy-weighted Symbols score (0-50), and Symbols average response time for correct items (0+). Participants will have opportunity to provide comments about the testing experience. |
| Secondary | Incidence of adverse events (AEs) | Up to 2 years | Safety and tolerability will be assessed on those randomized to receive metformin, as defined using the Common Terminology Criteria for Adverse Events version 5. Any AEs will be summarized with the maximum grade of each AE reported for each patient. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42211793 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06377696
GET https://conductscience.org/api/trials/v1/NCT06377696/registered