CogT pSOPT Intervention Study

NCT06005038 | Recruiting Phase 1 DMC

• 1 other identifier: 71235
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Subjective Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• composite cognitive measure

  a composite score of episodic memory and executive function. Episodic memory will be assessed using the Rey Auditory Verbal Learning and Brief Visuospatial Memory tests. Alternative forms of the tests will be used to reduce practice effects.The Z-transform scores across all assessment points within each test will be developed first to derive 2 composite scores (learning and delayed recall). Executive function will be measured using the EXAMINER, a computerized test package designed for RCTs. It includes 8 tests and calculates 4 sub-domain composite scores on working memory (Dot counting and N-back), inhibition (Flanker, Continuous Performance Test, and Anti-saccades), cognitive control (Dimensional Set Shifting), and Fluency (Phonemic Fluency and Category Fluency), and an overall composite score for executive function. A composite score synthesizing EXAMINER composite score, learning, and delayed recall will be created; higher indicates better performance.

  Baseline, Week 7, and 3-month

Secondary Outcomes (1)

• central autonomic network (CAN) functional integrity

  Baseline, Week 7, and 3-month

Study Arms (2)

pSOPT

EXPERIMENTAL

personalized cognitive training with a close-loop parasympathetic nervous system monitored component

Behavioral: pSOPT

MLA

PLACEBO COMPARATOR

computerized mental leisure activities

Behavioral: MLA

Interventions

pSOPT BEHAVIORAL

computerized cognitive training practicing speed of processing, the difficulty will be adjusted based on real-time monitored RMSSD (parasympathetic nervous system signals)

pSOPT

MLA BEHAVIORAL

computerized mental leisure activities on cross-word puzzle, Sudoku, and solitaire; ECG will also be applied.

MLA

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• T MRI contraindication

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

CogT Lab, Stanford University

Palo Alto, California, 94304-0000, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Feng Lin, BS

CONTACT

6082156005; cogtlab_stanford@stanford.edu

Sarah Therrien

CONTACT

(650) 497-8434; cogtlab_stanford@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 22, 2023
• Study Start: January 12, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)