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Recruiting NCT06005038

CogT pSOPT Intervention Study

Phase I Interventional Mild Cognitive Impairment Subjective Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pSOPT, MLA.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment, Subjective Cognitive Impairment. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Personalized Engine for Speed of Information Processing

Overview

(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.

Interventions

  • Behavioral pSOPT
    computerized cognitive training practicing speed of processing, the difficulty will be adjusted based on real-time monitored RMSSD (parasympathetic nervous system signals)
  • Behavioral MLA
    computerized mental leisure activities on cross-word puzzle, Sudoku, and solitaire; ECG will also be applied.

Primary outcome measures

  • composite cognitive measure [Time frame: Baseline, Week 7, and 3-month]
Secondary outcome measures (1)
  • central autonomic network (CAN) functional integrity [Time frame: Baseline, Week 7, and 3-month]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • CogT Lab, Stanford University — Palo Alto

Identifiers

NCT: NCT06005038 · 71235

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗