CogT pSOPT Intervention Study
Recruiting now · Phase 1
Conditions studied: Mild Cognitive Impairment, Subjective Cognitive Impairment
In brief
(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.
Key facts
- Study ID
- NCT06005038
- Run by
- Stanford University
- People needed
- 50
- Starts
- 2024-01-12
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2024-05-17
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: accepted.
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 may not qualify 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.
Where it is running
- CogT Lab, Stanford University — Palo Alto, California, United States (enrolling)
Full record on ClinicalTrials.gov
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