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CogT pSOPT Intervention Study

Stanford University · NCT06005038

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 60+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
50
US sites recruiting
1
Study start
January 12, 2024
Record last updated
May 17, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

(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.

Being studied: pSOPT; MLA

Conditions: Mild Cognitive Impairment; Subjective Cognitive Impairment

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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.

Recruiting US locations

  • CogT Lab, Stanford University

    Palo Alto, CA 94304-0000

    Site contact: Sarah Therrien · 650-497-8434 · stherrie@stanford.edu

Study contacts (from the official record)

  • Feng Lin, BS · 6082156005 · cogtlab_stanford@stanford.edu
  • Sarah Therrien · (650) 497-8434 · cogtlab_stanford@stanford.edu
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CogT pSOPT Intervention Study (NCT06005038) | Bored Studies