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CogT pSOPT Intervention Study

RecruitingPhase 1Healthy volunteers welcome

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Who can join

Ages 60 and older · All sexes · Healthy volunteers welcome

Full eligibility criteria
Inclusion Criteria:

1. 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.
2. intact score for San Diego Brief Assessment of Capacity to Consent (UBACC).
3. 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.
4. age 60+,
5. read and understand English
6. adequate visual and hearing acuity for testing by self-report,
7. community-dwelling (including independent living).

Exclusion Criteria:

1. current enrollment in another cognitive improvement study;
2. uncontrollable major depression;
3. major cerebrovascular and cardiovascular diseases (e.g., congestive heart failure, pacemaker, prior myocardial infarction);
4. having an active legal guardian (indicating impaired capacity for decision making);
5. currently pregnant
6. 3T MRI contraindication
7. 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.

About the study

(JUSTIFICATION: This is the R33 stage of an NIH funded R21/R33 study. R21 stage (IRB-61727) was focused on intervention development; R33 stage will focus on pilot testing the effect of the intervention. The R21 phase was not considered a NIH defined clinical trial; R33 will be considered a NIH defined clinical trial)

The purpose is to develop and test the effect of a "personalized" computer-based cognitive training program. The personalized program tailors the difficulty of the training tasks using a participant's biofeedback (i.e., heart rate) and cognitive performance. Such a personalization will ensure that the participant can perform at his/her ideal training capacity. Participants will be randomized into one of 2 groups and each group will play a different version of computerized training game and have ECG collected to allow subject blinding.

What is being tested

Sponsor: Stanford University · Participants: 50 · Started: Jan 12, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06005038

Locations in the U.S.

CaliforniaCogT Lab, Stanford University, Palo Alto

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.