- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06916221
BID LTM Digital Intervention in Aging
Behavioral Intervention Development Core - Long Term Memory Digital Intervention in Aging
Healthy aging is typically accompanied by diminished capability for learning and retrieval of high-fidelity long-term memory (LTM). The decline in these faculties is accelerated and becomes significant deficits in LTM and cognitive control functions at the level or a diagnosis of Mild Cognitive Impairment (MCI). Training with the navigation game, relative to training with control games, is expected to improve LTM performance for older adult participants.
Researchers will compare two different digital interventions to assess whether they may be helpful in improving cognitive function.
Participants will conduct study activities remotely (e.g., at-home):
- Baseline Assessment. Complete a series of cognitive assessments and surveys.
- Intervention. Engage in a digital intervention for up to 8 weeks.
- Post Intervention Assessment. Complete the same cognitive assessments and surveys as the Baseline Assessment.
- Follow-Up Assessment. Six months after the intervention ends, participants will complete the same cognitive assessments and surveys as the Baseline Assessment.
Study Overview
Status
Intervention / Treatment
Detailed Description
Older adult participants consent and enroll in the LTM Digital Intervention, which is a randomized control trial (RCT) administered on the Neuroscape Nexus web-based research platform. Enrolled participants are randomly assigned to either of two arms that will play memory-based games.
Participants are provided by the study team with an Apple iPad 10th Generation (2024) at their home address, which will enable them to complete all study tasks at home via Nexus. All required applications will be pre-loaded on the device.
Participants will receive notifications and reminders to complete study tasks by email, through in-app reminders, or SMS. They can view their task list and progress in their personal dashboard in Nexus.
Study procedures include a series of surveys and brief tests of memory and attention as Baseline Tests, which make take up to 120 minutes and can be completed across more than one session.
Participants will engage with their assigned training application to complete 45 minutes of training, several days a week for up to 8 weeks for a total of 1000 minutes of training. Participants will be randomly assigned to one of two intervention apps, which encourage long-term memory.
Once their assigned training regimen is complete, participants will again fulfill a series of surveys and brief tests of memory and attention as Post-Training Tests, which make take up to 120 minutes and can be completed across more than one session.
Six months after completion of all Post-Training Tests, participants will be fulfill a third series of surveys and brief tests of memory and attention as Follow-Up Tests, which make take up to 120 minutes and can be completed across more than one session.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Melissa Arioli, AB
- Phone Number: (415) 502-7321
- Email: bid.core@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94158
- Recruiting
- University of California, San Francsico
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Minimum of 12 years of education
- English fluency: All task instructions are presented in English language text. In order to control for sufficient and equivalent participant comprehension of the procedures and instructions, we require their self-report of fluency in English.
- Normal or corrected-to-normal vision
- Normal or corrected-to-normal hearing
- Medically healthy older adults, including those with below-average cognitive performance /MCI patients without dementia referred by neuropsychologists (i.e., no participant medical records will be reviewed).
Exclusion Criteria:
- Under the age of 60
- Clinical diagnosis of neurological or psychiatric disorder Clinical diagnosis of dementia or AD8 score of >4
- Visually or hearing impaired without correction to normal
- Regularly (one or more times per week) practicing an instrument within the last year
- 10 years or more of formal musical instrument training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Long Term Memory
Multi-session cognitive intervention as a computer game that presents an adaptive spatial wayfinding challenge.
|
Tablet computer game designed to stimulate environmental enrichment via an adaptive and immersive experience learning virtual neighborhoods and errands in order to complete assigned errands.
|
|
Active Comparator: Worder
Multi-session cognitive intervention as a computer game that presents a word puzzle.
|
Tablet computer game designed to stimulate interest in solving word puzzles, much like the Boggle game.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MDT change in recognition memory
Time Frame: baseline promptly before, post-training promptly after regimen is completed, and follow up six months after post-training tests
|
Psychometric test for proportion correct in memory for studied images of common objects versus paired similar lures
|
baseline promptly before, post-training promptly after regimen is completed, and follow up six months after post-training tests
|
|
TOUR change in cued recall memory
Time Frame: baseline promptly before, post-training promptly after regimen is completed, and follow up six months after post-training tests
|
Psychometric test for proportion of details correctly recalled from recent autobiographical memory
|
baseline promptly before, post-training promptly after regimen is completed, and follow up six months after post-training tests
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive Assessment change in working memory
Time Frame: baseline promptly before, post-training promptly after regimen is completed, and follow up six months after post-training tests
|
Psychometric test for proportion of number of correctly identified images from working memory span
|
baseline promptly before, post-training promptly after regimen is completed, and follow up six months after post-training tests
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Peter E Wais, PhD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-43268
- P30AG086635 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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