TerminatedNot Applicable

Impact of Challenging Engagement on Cognition in Older Adults

Stopped: Analysis of cognitive data from the first 50 participants indicated that there was not a significant effect of the intervention on any key outcome measures and that a small increase in sample size was unlikely to improve this.

United States50 participantsStarted 2019-06-01

Plain-language summary

The study will enroll 90 participants in the "Impact of Challenging Engagement" study and assign them to one of three groups: high-demand photography, moderate-demand photography, and active placebo. These initial groups will allow us to collect data and address the feasibility of converting the project into a full trial. Participants will participate in one of three different engagement conditions for 15 hours per week, based on successful results from the initial Active Interventions for the Aging Mind (AIM) study - approved by University of Texas Southwestern (UTSW) Institutional Review Board (IRB) #072010-144. In the Impact of Challenging Engagement study, the lab will expand on the results of the AIM study to determine if high-demand activities result in any observable brain changes when compared to moderate demand or placebo activities. Behavioral and neural measures of cognitive change will be assessed, providing considerable insight into mechanisms of change. Participants will be characterized thoroughly in terms of behavioral tests of cognitive function, and a subset of subjects who meet neuroimaging criteria will undergo a functional magnetic resonance imaging (fMRI) procedure.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants must be adults at least 60 years old. * At least 35 percent of participants will be men, and at least 15 percent will be minorities. * 10th grade education or higher is required * Fluent in English * Alzheimer's Disease Assessment Scale-Cognitive (ADAS-COG) score of zero (a perfect score). * A score of 18 or higher on the Barthel Index of Daily Functioning. * Right-handed for magnetic resonance imaging (MRI) scanning. Exclusion Criteria: * Telephone Interview for Cognitive Status (TICS) lower than 25 * Montreal Cognitive Assessment (MOCA) score lower than 26 * Depression based on Center for Epidemiologic Studies Depression Scale (CESD) screening (a score of 27 or greater) * Major psychiatric or neurological disorder * Chemotherapy presently or in past year * Coronary bypass presently or in past year * History of major substance abuse * History of central nervous system disease or brain injury * Corrected vision poorer than 20/40 on Snellen Eye Chart after correction * Recreational drug use in past six months * Conditions which would contra-indicate MRI: Prior surgeries and/or implant of pacemakers, pacemaker wires, artificial heart valve, brain aneurysm surgery, middle ear implant, non-removable hearing aid or jewelry, braces or extensive dental work, cataract surgery or lens implant, implanted mechanical or electrical device, artificial limb or joint; foreign metallic objects in the body such as bullets, ball-bullets or ball bearings (BB…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Change in Episodic Memory Function

Timeframe: Baseline and 16 weeks

Mean Change in Neural Modulation Capacity - Primary Brain Outcome Measure

Timeframe: Baseline and 16 weeks

Trial details

NCT IDNCT03962439

SponsorThe University of Texas at Dallas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-06

Results submitted2024-02-08

View on ClinicalTrials.gov More Cognitive Change trials