Actively Recruiting
ACTIVE MIND: An Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia
Led by University of Alabama at Birmingham · Updated on 2025-12-11
1305
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
U
University of Florida
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the best combination of cognitive training (CT) exercises to improve daily functioning and delay dementia in older adults with mild cognitive impairment (MCI). This adaptive, randomized clinical trial aims to compare different CT combinations against an active control of cognitive stimulation, focusing on reducing the occurrence of dementia. The study also explores related brain imaging and blood-based biomarkers to understand the effects better. Participants will be assigned to one of five groups: four groups will complete different combinations of computerized cognitive training exercises, and one group will engage in computerized cognitive stimulation activities. Each participant will complete 40 sessions lasting 60 minutes each, scheduled two to three times per week over 16 weeks. All groups will have equivalent session frequency and duration. Throughout the study, participants will undergo assessments including tests of everyday function such as Timed Instrumental Activities of Daily Living and the iFunction performance efficiency index. Dementia incidence will be monitored during follow-up visits up to two years after the intervention. Cognitive performance, executive function, and attention will also be evaluated immediately after the intervention. The study includes safety monitoring and will last several years to observe long-term outcomes.
CONDITIONS
Brief Title
The Active Mind Trial: An Adaptive Randomized Trial to Improve Function and Delay Dementia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 55 to 89 years of age
- Montreal Cognitive Assessment Score of 18-27 inclusive
- History of some change in cognitive function relative to established baseline
- Either a Clinical Dementia Rating (CDR) of 0.5 or a CDR of 0 with a clinical diagnosis of mild cognitive impairment based on standardized neuropsychological testing
- Stable dose for at least 30 days if using medications prescribed for dementia such as Namenda, Memantine, or Donepezil
- Adequate hearing with thresholds less than or equal to 50 dB at 1000 and 2000 Hz in at least one ear
- Adequate vision to read a computer screen at 20/50 or better
- Adequate motor ability to use a computer mouse or touch a screen
- Willing and able to complete all study activities and provide informed consent
- Ability to understand and comply with study procedures for the study duration
You will not qualify if you...
- Currently enrolled in another randomized clinical trial or research study assessing cognition
- Diagnosis of dementia
- Clinical Dementia Rating Scale of 1 or greater
- History of large vessel stroke with significant residual impairment
- History of moderate to severe traumatic brain injury with residual cognitive symptoms
- History of brain tumor
- Planned or recent surgery requiring anesthesia, chemotherapy, or radiation within six months after screening
- Diagnosis of congestive heart failure
- Primary diagnosis of idiopathic Parkinson's disease
- Diagnosis of multiple sclerosis or amyotrophic lateral sclerosis
- Any non-neurodegenerative neurological disorder interfering with study activities
- Unstable medical conditions affecting cognition or ability to participate
- Geriatric Depression Scale score greater than 5 out of 15 (treated and stable mood disorders with lower scores allowed)
- Other unstable or clinically significant medical conditions like ongoing substance abuse or psychosis
- Previous participation in 10 or more hours of computerized cognitive intervention in the past two years
- Previous participation in cognitive intervention research at this study site within two years
- Plans to be unavailable for more than three weeks in the six months following screening
- Contraindications to MRI such as pacemakers, metal implants, or claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants complete computerized cognitive training or cognitive stimulation sessions aimed at improving daily function and delaying dementia onset.
Two to three sessions per week, each lasting 60 minutes, for a total of 40 sessions
Duration - 6 months to 2 years
Participants are assessed for dementia incidence and cognitive function changes after completing the training.
1 to 2 follow-up visits over this period
Trial Site Locations
Total: 6 locations
1
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
2
University of Florida
Gainesville, Florida, United States, 32611
Actively Recruiting
3
Active Mind Study
Tampa, Florida, United States, 33617
Actively Recruiting
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Active, Not Recruiting
5
Clemson University
Greenville, South Carolina, United States, 29607
Actively Recruiting
6
Clemson University
Seneca, South Carolina, United States, 29672
Actively Recruiting
Research Team
J
Jerri Edwards, PhD
J
Jade Sutfin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
5
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