Mild Cognitive ImpairmentPhase 1NCT06005038
CogT pSOPT Intervention Study
A Phase 1 study testing pSOPT and MLA in people with Mild Cognitive Impairment and Subjective Cognitive Impairment, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Subjective Cognitive Impairment
- What is being tested?
- pSOPT and MLA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2024to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
CogT Lab, Stanford University
Palo Alto, California, 94304-0000
Sarah Therrien, 650-497-8434, stherrie@stanford.edu
About this study
Official title: Personalized Engine for Speed of Information Processing
(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.
- Being tested
- pSOPT, MLA
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pSOPTBehavioural
computerized cognitive training practicing speed of processing, the difficulty will be adjusted based on real-time monitored RMSSD (parasympathetic nervous system signals)
MLABehavioural
computerized mental leisure activities on cross-word puzzle, Sudoku, and solitaire; ECG will also be applied.
| Study group | Role | What they receive |
|---|---|---|
| pSOPT | Experimental | personalized cognitive training with a close-loop parasympathetic nervous system monitored component Receives: Behavioral: pSOPT |
| MLA | Placebo comparator | computerized mental leisure activities Receives: Behavioral: MLA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 7, and 3-month
Secondary outcomes (1)
central autonomic network (CAN) functional integrity
BOLD during resting-state will be collected using a gradient echo-planar imaging sequence. The functional scans will be acquired using simultaneous multi-slice at sub-second TRs. An in-scanner camera will be used to ensure compliance. Identification of CAN involved networks for the study: a functional network template along with 268 ROIs described previously will be used. In this functional template, CAN related networks will be focused, including SN, DMN, subcortical network, and frontoparietal networks, along with ACC subregions. The data will be analyzed using the FSL software packages. fMRI preprocessing will consist of motion correction, slice-timing correction, normalization, and Gaussian spatial smoothing (FWHM 8mm). To calculate resting-state and task-related fMRI, the correlation coefficient between ROI pair across the time course will be Fisher Z-transformed and averaged to derive summary scores for network strength; higher indicates stronger network strength.
Measured: Baseline, Week 7, and 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start12 Jan 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Lin, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005038
- Sponsor's protocol ID
- 71235
- Status last verified
- May 2024
- First submitted
- 7 Aug 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Engine for Speed of Information Processing
- ClinicalTrials.gov ID
- NCT06005038
- Acronym / sponsor ID
- 71235
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pSOPT | Experimental | Behavioral: pSOPTpersonalized cognitive training with a close-loop parasympathetic nervous system monitored component |
| MLA | Placebo comparator | Behavioral: MLAcomputerized mental leisure activities |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pSOPTcomputerized cognitive training practicing speed of processing, the difficulty will be adjusted based on real-time monitored RMSSD (parasympathetic nervous system signals) | Behavioural | pSOPT |
| MLAcomputerized mental leisure activities on cross-word puzzle, Sudoku, and solitaire; ECG will also be applied. | Behavioural | MLA |
Primary outcome
composite cognitive measure
Time frame: Baseline, Week 7, and 3-month
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.
1 secondary outcome
central autonomic network (CAN) functional integrity
Time frame: Baseline, Week 7, and 3-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pSOPT and MLA in people with Mild Cognitive Impairment and Subjective Cognitive Impairment, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Lin, BS (6082156005, cogtlab_stanford@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite cognitive measure (time frame: Baseline, Week 7, and 3-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.