Clinical trial NCT06918704: BID WM Digital Intervention in Aging
Official title: Behavioral Intervention Development Core - Working Memory Digital Intervention in Aging
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Working Memory
Inhibitory Control
Keywords: Cognitive Training
Working Memory
Inhibitory Contorl
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-04-09
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if engaging with an digital intervention may improve cognitive function. The main questions it aims to answer are:

1. Does engagement in with a digital intervention improve working memory?
2. Does engagement in with a digital intervention improve inhibitory control?

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: During the Baseline Assessment, participants will complete web-based cognitive assessments and surveys. The assessments will address various cognitive functions including working memory, long-term memory, inhibitory control, and sustained attention. Surveys will include a characterization of expectancy for the intervention, ratings of stress, and background health information. The Baseline Assessment will take up to 120 minutes and can be completed across more than one session.

During the Intervention, participants will be provided an iPad tablet to engage with the assigned intervention app. Participants will be randomly assigned to one of two intervention apps. Regardless of the assigned intervention, participants will engage with the app for 25-45 minutes of training per day, 5 days a week for up to 8 weeks for a total of 1000 minutes of training.

After the intervention, participants will complete a Post Intervention Assessment and 6 month later, a Follow-Up Assessment. Both of these assessment periods will consist of the same cognitive assessments and surveys as conducted during the Baseline Assessment.

Upon completion of all study activities, participants will be able to keep the iPad as a gift for their voluntary participation.

Eligibility criteria: Inclusion Criteria:

* Minimum of 12 years of education
* English fluency
* Normal or corrected-to-normal vision
* Normal or corrected-to-normal vision
* Medically healthy older adults including those with below-average cognitive performance or mild cognitive impairment patients without dementia

Exclusion Criteria:

* Under the age of 60
* Clinical diagnosis of neurological or psychiatric disorder
* Visually or hearing impaired without correction to normal
* Clinical diagnosis of dementia or AD8 score of \>4
* Regularly (one or more times per week) practicing an instrument within the last year

Primary outcomes:
measure: Working Memory
timeFrame: Immediately before the intervention, Immediately after the intervention, 6 months after the intervention
Secondary outcomes:
measure: Inhibitory Control
timeFrame: Immediately before the intervention, Immediately after the intervention, 6 months after the intervention
measure: Inhibitory Control
timeFrame: Immediately before the intervention, Immediately after the intervention, 6 months after the intervention
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Theodore Zanto, PhD
role: PRINCIPAL_INVESTIGATOR
References: