Personalized cognitive training program for mild cognitive impairment

Personalized Engine for Speed of Information Processing

This study is trying out a personalized computer game designed to help people with mild cognitive impairment improve their thinking skills by adjusting the difficulty based on their heart rate and performance.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT06005038 on ClinicalTrials.gov

What this trial studies

This study aims to develop and pilot test a personalized computer-based cognitive training program designed for individuals with mild cognitive impairment. The program adjusts the difficulty of training tasks based on participants' biofeedback, such as heart rate, and cognitive performance to optimize their training experience. Participants will be randomly assigned to one of two groups, each engaging in different versions of a computerized training game while their ECG is monitored to maintain blinding. The goal is to assess the effectiveness of this tailored approach in improving cognitive function.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 60 and older who exhibit mild cognitive impairment and can understand and participate in the training program.

Not a fit: Patients currently enrolled in other cognitive improvement studies or those with uncontrollable major depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could enhance cognitive function in patients with mild cognitive impairment, potentially delaying the progression to more severe cognitive decline.

How similar studies have performed: Other studies have shown promise in using personalized cognitive training approaches, suggesting potential for success in this novel application.

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.

Where this trial is running

Palo Alto, California

• CogT Lab, Stanford University — Palo Alto, California, United States (Recruiting)

Study contacts

• Study coordinator: Feng Lin, BS

Conditions Mild Cognitive Impairment; Subjective Cognitive Impairment