Clinical trial NCT06916221: BID LTM Digital Intervention in Aging
Official title: Behavioral Intervention Development Core - Long Term Memory Digital Intervention in Aging
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Long-Term Memory
Inhibitory Control
Keywords: cognitive training
cognitive aging
memory
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-04-08
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: TREATMENT

Brief summary: 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):

1. Baseline Assessment. Complete a series of cognitive assessments and surveys.
2. Intervention. Engage in a digital intervention for up to 8 weeks.
3. Post Intervention Assessment. Complete the same cognitive assessments and surveys as the Baseline Assessment.
4. Follow-Up Assessment. Six months after the intervention ends, participants will complete the same cognitive assessments and surveys as the Baseline Assessment.

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.

Eligibility criteria: 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

Primary outcomes:
measure: MDT change in recognition memory
timeFrame: baseline promptly before, post-training promptly after regimen is completed, and follow up six months after post-training tests
measure: TOUR change in cued recall memory
timeFrame: baseline promptly before, post-training promptly after regimen is completed, and follow up six months after post-training tests
Secondary outcomes:
measure: Cognitive Assessment change in working memory
timeFrame: baseline promptly before, post-training promptly after regimen is completed, and follow up six months after post-training tests
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francsico
state: California
Study officials:
affiliation: University of California, San Francisco
name: Peter E Wais, PhD
role: PRINCIPAL_INVESTIGATOR
References: