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CogT pSOPT Intervention Study

CogT pSOPT Intervention Study

Recruiting
60 years and older
All
Phase 1

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Overview

(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.

Eligibility

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.

Study details
    Mild Cognitive Impairment
    Subjective Cognitive Impairment

NCT06005038

Stanford University

28 May 2024

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