- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06918704
BID WM Digital Intervention in Aging
Behavioral Intervention Development Core - Working Memory Digital Intervention in Aging
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:
- Does engagement in with a digital intervention improve working memory?
- 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):
- 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
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Melissa Arioli
- Phone Number: (415) 506-7321
- Email: Bid.Core@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94621
- Recruiting
- University of California, San Francisco
-
-
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
- 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 >3
- Regularly (one or more times per week) practicing an instrument within the last year
- 10 or more years 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: Coherence Intervention
Participants in this arm will engage with the Coherence Intervention.
|
Coherence is a music-based rhythm training app.
|
|
Active Comparator: Worder Intervention
Participants in this arm will engage with the Worder intervention.
|
Worder is a word search app.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Working Memory
Time Frame: Immediately before the intervention, Immediately after the intervention, 6 months after the intervention
|
Working memory performance will be assessed with a delayed match-to-sample task.
|
Immediately before the intervention, Immediately after the intervention, 6 months after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inhibitory Control
Time Frame: Immediately before the intervention, Immediately after the intervention, 6 months after the intervention
|
Inhibitory control will be assessed with the Stroop task.
|
Immediately before the intervention, Immediately after the intervention, 6 months after the intervention
|
|
Inhibitory Control
Time Frame: Immediately before the intervention, Immediately after the intervention, 6 months after the intervention
|
Inhibitory control performance will be assessed by distractors within a delayed match-to-sample task.
|
Immediately before the intervention, Immediately after the intervention, 6 months after the intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Theodore Zanto, 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-42925
- 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.
Clinical Trials on Mild Cognitive Impairment (MCI)
-
University of FloridaRecruitingMild Cognitive Impairment (MCI) | Mild Cognitive Impairment | MCIUnited States
-
High Point UniversityWake Forest University Health Sciences; Hebrew SeniorLifeRecruitingMild Cognitive Impairment (MCI)United States
-
Azienda Ospedaliera SS. Antonio e Biagio e Cesare...Dr. Schär AG / SPARecruitingMild Cognitive Impairment (MCI)Italy
-
Immunotec Inc.RecruitingMild Cognitive Impairment (MCI)Canada
-
Çankırı Karatekin UniversityCompletedMild Cognitive Impairment (MCI)Turkey (Türkiye)
-
University of AlbertaCompleted
-
Friedhelm HummelThe Novartis Foundation; Wyss Center for Bio and Neuroengineering; Clinique Romande... and other collaboratorsCompletedMild Cognitive Impairment (MCI)Switzerland
-
Meir Medical CenterTerminatedMild Cognitive Impairment (MCI)Israel
-
Singapore General HospitalSingapore Health ServicesNot yet recruitingMild Cognitive Impairment (MCI) | Mild Cognitive Impairment
-
Xuanwu Hospital, BeijingNot yet recruitingMild Cognitive Impairment (MCI)China
Clinical Trials on Coherence
-
University of California, IrvineBeckman Laser Institute University of California IrvineCompletedCerebral AneurysmUnited States
-
Brighton and Sussex University Hospitals NHS TrustCompletedAge Related Macular Degeneration | Cataract Senile | Epiretinal Membrane | Vitreomacular Traction | Macula HoleUnited Kingdom
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CompletedTransitional Cell Carcinoma of Urinary TractNetherlands
-
Samsung Medical CenterCompleted
-
Khon Kaen UniversityNot yet recruiting
-
Kasr El Aini HospitalCompletedTractional Retinal Detachment | Diabetic Vitreous HemorrhageEgypt
-
Khon Kaen UniversityRecruitingRetinal Vascular | Twin Pregnancy, Antepartum Condition or Complication | Choroidal EffusionThailand
-
Fondation Ophtalmologique Adolphe de RothschildNot yet recruiting
-
Centre Hospitalier Universitaire de la RéunionRecruiting
-
Centre Hospitalier Universitaire de la RéunionRecruitingPost-traumatic Stress DisorderReunion