| NCT ID | NCT06005038 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Stanford University |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-12 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2024-01-12 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06005038 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06005038 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06005038 currently recruiting?
Yes, NCT06005038 is actively recruiting participants. Contact the research team at cogtlab_stanford@stanford.edu for enrollment information.
Where is the NCT06005038 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT06005038 clinical trial?
NCT06005038 is sponsored by Stanford University. The trial plans to enroll 50 participants.