NCT06916221

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Aug 2025Jul 2028

First Submitted

Initial submission to the registry

March 24, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

August 20, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

2.4 years

First QC Date

March 24, 2025

Last Update Submit

March 31, 2026

Conditions

Keywords

cognitive trainingcognitive agingmemory

Outcome Measures

Primary Outcomes (2)

  • MDT change in recognition memory

    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

    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 Outcomes (1)

  • Cognitive Assessment change in working memory

    baseline promptly before, post-training promptly after regimen is completed, and follow up six months after post-training tests

Study Arms (2)

Long Term Memory

ACTIVE COMPARATOR

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

Behavioral: Long Term Memory

Worder

ACTIVE COMPARATOR

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

Behavioral: Worder

Interventions

WorderBEHAVIORAL

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

Worder

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.

Long Term Memory

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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
  • years or more of formal musical instrument training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francsico

San Francisco, California, 94158, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Long Short Term Memory

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Recurrent Neural NetworksNeural Networks, ComputerMathematical Concepts

Study Officials

  • Peter E Wais, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Arioli, AB

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2025

First Posted

April 8, 2025

Study Start

August 20, 2025

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

De-identified data to be shared includes demographic, cognitive assessments, survey, and behavioral outcomes.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE

Locations