BID LTM Digital Intervention in Aging

NCT ID: NCT06916221

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-20

Study Completion Date

2028-06-28

Brief Summary

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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

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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.

Conditions

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Long-Term Memory Inhibitory Control

Keywords

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cognitive training cognitive aging memory

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
After recruitment, participants are randomly assigned to one of two arms, Participants and experimenters with whom they interact during the experiment are blind to treatment purpose of the randomly-assigned arm. First-level analysis of the data (baseline, post training and follow up) performed blind to the participant's arm.

Study Groups

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Long Term Memory

Multi-session cognitive intervention as a computer game that presents an adaptive spatial wayfinding challenge.

Group Type ACTIVE_COMPARATOR

Long Term Memory

Intervention Type BEHAVIORAL

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.

Worder

Multi-session cognitive intervention as a computer game that presents a word puzzle.

Group Type ACTIVE_COMPARATOR

Worder

Intervention Type BEHAVIORAL

Tablet computer game designed to stimulate interest in solving word puzzles, much like the Boggle game.

Interventions

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Long Term Memory

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.

Intervention Type BEHAVIORAL

Worder

Tablet computer game designed to stimulate interest in solving word puzzles, much like the Boggle game.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter E Wais, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francsico

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Melissa Arioli, AB

Role: CONTACT

Phone: (415) 502-7321

Email: [email protected]

Other Identifiers

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P30AG086635

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-43268

Identifier Type: -

Identifier Source: org_study_id