mSIM: Mobile Simultaneous Aerobic Exercise and Memory Training Intervention for Amnestic Mild Cog… (NCT04185298) | Clinical Trial Compass
TerminatedNot Applicable
mSIM: Mobile Simultaneous Aerobic Exercise and Memory Training Intervention for Amnestic Mild Cognitive Impairment
Stopped: Due to difficulties in recruitment and completion rates, the study was considered to be not feasible. After 4 years, only 12 participants were randomized. Of the 8 mSIM arm participants, only 2 completed the study.
United States12 participantsStarted 2019-10-01
Plain-language summary
The mSIM study involves developing and conducting feasibility testing of a web-based application that will deliver mobile-based simultaneous exercise and memory skills training program (mSIM) for amnesic Mild Cognitive Impairment (aMCI) patients.
The randomized control trial (RCT) will evaluate the efficacy of mSIM on memory performance and everyday functioning using 2 study arms (Group 1 activity monitoring control (via Fitbit) (CON) vs Group 2 mSIM intervention plus activity monitoring via Fitbit). mSIM treatment response will be evaluated using neuropsychological and functional evaluation. Concentration levels of peripheral biomarkers Brain-derived neurotrophic factor (BDNF) and norepinephrine (NE) also be assessed.
Who can participate
Age range
50 Years – 80 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
* Subjects must be age 50 to 80 at time of informed consent.
* Subjects must confirm an aMCI diagnosis either by providing records from a clinical assessment within 6 months of enrollment in this study or through a brief memory assessment by study staff at screening.
* Subjects must be proficient in spoken and written English for consenting as well as for study participation since the intervention in this study is currently only available in English.
* Subjects with medical conditions must be stable for these conditions. Stable control on medication is acceptable.
* Subjects, with or without assistance, must be able to use a computer and web interface. If assistance is needed, it must be readily available to them.
* Subjects are required to have internet with Wi-Fi at the location of their mSIM training.
* Subject must have normal visual acuity (or corrected to normal) and normal color vision as indicated by self-report.
* Subject must have adequate hearing acuity as indicated by self-report.
* Subject must have adequate motor capacity to use a mobile phone/iPad/computer as indicated by self-report.
* Subjects must be able to provide medical clearance to participate in an unsupervised, moderate intensity exercise program from a physician.
Exclusion Criteria
* Subjects must not have an existing diagnosis of a neurodegenerative disorder (e.g., Alzheimer's Disease, Lewy Body Dementia, Frontal-Temporal Dementia).
* Subjects must not have a prior diagnosis th…
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
1
Memory Function Composite Score
Timeframe: Baseline, approximately 3 months and approximately 6 months
2
Functional Abilities
Timeframe: Baseline, approximately 3 months and approximately 6 months