NCT06005038 · Phase 1 · RECRUITING
CogT pSOPT Intervention Study
This trial is testing a personalized computer-based brain training program called pSOPT for people with mild or subjective cognitive impairment. The program adjusts its difficulty in real time based on your heart rate and cognitive performance, aiming to keep you working at your best capacity. It is a Phase 1 pilot study — meaning researchers are still gathering early data on whether this approach works and is safe, not a proven treatment.
You may qualify if
- criteria related to defining "mild cognitive impairment": a. Presence of memory complaint; b. Rey Auditory Verbal Learning Test delayed recall (for memory) \< 59% of age-adjusted norm; c. Montreal Cognitive Assessment (for global cognition) ranged 18 and 27; d. Functional Assessment Questionnaire (for activities of daily living) \< 20.
- intact score for San Diego Brief Assessment of Capacity to Consent (UBACC).
- if a participant is on AD medication (i.e., memantine, cholinesterase inhibitors, amyloid antibodies), antidepressants, anxiolytics, or vascular risk or diseases related medications (e.g., beta-blocker), the dose should be stable for 3 months prior to recruitment.
- age 60+,
- read and understand English
- adequate visual and hearing acuity for testing by self-report,
- community-dwelling (including independent living).
You're excluded if
- current enrollment in another cognitive improvement study;
- uncontrollable major depression;
- major cerebrovascular and cardiovascular diseases (e.g., congestive heart failure, pacemaker, prior myocardial infarction);
- having an active legal guardian (indicating impaired capacity for decision making);
- currently pregnant
- 3T MRI contraindication
- Neurological conditions: Neurodegenerative disease diagnosis such as Parkinson's, Alzheimers, dementia, multiple sclerosis. Of note, other neurological conditions/injury such as stroke, seizures, traumatic brain injury, will be evaluated for inclusion/exclusion on a case-by-case basis based on event recency, severity, and recovery.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-05-17