Status:
RECRUITING
CogT pSOPT Intervention Study
Lead Sponsor:
Stanford University
Conditions:
Mild Cognitive Impairment
Subjective Cognitive Impairment
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief Summary
(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 interventio...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
January 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06005038
Start Date
January 12 2024
End Date
December 31 2026
Last Update
May 17 2024
Active Locations (1)
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1
CogT Lab, Stanford University
Palo Alto, California, United States, 94304-0000