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NCT06005038 · ClinicalTrials.gov registry record · Phase 1
CogT pSOPT Intervention Study
A Phase 1 study of Mild Cognitive Impairment and Subjective Cognitive Impairment, sponsored by Stanford University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06005038: Recruiting Phase 1 study of Mild Cognitive Impairment and Subjective Cognitive Impairment, sponsored by Stanford University.
NCT06005038 is a Phase 1 study of Mild Cognitive Impairment and Subjective Cognitive Impairment that is actively recruiting participants, run by Stanford University. The registered enrollment target is 50 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06005038, a Phase 1 study of Mild Cognitive Impairment and Subjective Cognitive Impairment, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- BEHAVIORAL pSOPT
- BEHAVIORAL MLA
Study Locations (1)
California
- CogT Lab, Stanford University - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-01-12 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT06005038 shows while recruiting
NCT06005038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions - of which pSOPT is the first listed.
NCT06005038 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06005038 about?
NCT06005038 is a clinical study titled "CogT pSOPT Intervention Study". (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 defin...
What is the current status of trial NCT06005038?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2024-01-12. Estimated completion is 2026-12-31.
What conditions does trial NCT06005038 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Subjective Cognitive Impairment.
What interventions are being tested in trial NCT06005038?
The interventions under investigation include: pSOPT (BEHAVIORAL), MLA (BEHAVIORAL).
Who is sponsoring clinical trial NCT06005038?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06005038 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06005038's enrollment target sits among peer trials
50 140th of 205 higher than 62 of 205 other Mild Cognitive Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Cognitive Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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