Actively Recruiting
The Active Mind Trial: An Adaptive Randomized Trial to Improve Function and Delay Dementia
Led by University of Alabama at Birmingham · Updated on 2025-12-11
1305
Participants Needed
6
Research Sites
443 weeks
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
Older adults at risk for dementia show a variety of cognitive deficits, which can be ameliorated by different cognitive training (CT) exercises. The best combination of CT exercises is unknown. The aim is to discover the most efficacious combination of CT exercises as compared to cognitive stimulation (which will serve as a stringent, active control) to modify the functional trajectories of older adults' with MCI, who are at high risk for dementia. The primary objective of the U01 phase was to design and pilot-test an adaptive, randomized clinical trial (RCT) of cognitive training (CT) combinations aimed to enhance performance of instrumental activities of daily living (IADL) among persons with mild cognitive impairment (MCI). In the R01 phase, the objective is to identify the best combination of CT exercises to delay dementia onset among persons with MCI. The longitudinal endpoint goal is reducing incident dementia. The primary aim of the study is to determine which CT combination has the best probability to delay dementia by producing the largest IADL improvements. The study further aims to explore neuroimaging and novel blood-based biomarkers.
CONDITIONS
Official 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...
- Age 55 to 89 years
- Montreal Cognitive Assessment Score between 18 and 27 inclusive
- History of some change in cognitive function and either a Clinical Dementia Rating (CDR) of 0.5 or CDR of 0 with a clinical diagnosis of mild cognitive impairment (MCI) based on evaluation
- Stable dose for at least 30 days if using medications for dementia such as Namenda, Memantine, Donepezil, or others
- 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 with binocular visual acuity of 20/50 or better
- Adequate motor skills to touch a computer screen or use a mouse
- Willing and able to complete all study activities
- Capable of providing informed consent
- Ability to understand and comply with study procedures for the entire duration of the study
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 motor or cognitive impairment
- History of moderate to severe traumatic brain injury with lasting cognitive symptoms
- History of brain tumor
- Planned surgery requiring anesthesia, chemotherapy, or radiation in the six months after screening
- Diagnosis of congestive heart failure
- Primary diagnosis of idiopathic Parkinson's disease
- Diagnosis of multiple sclerosis or amyotrophic lateral sclerosis (ALS)
- Presence of non-neurodegenerative neurological disorders interfering with study activities
- Unstable medical conditions causing cognitive fluctuations, such as unstable diabetes or oxygen-dependent COPD
- Geriatric Depression Scale score greater than 5 out of 15 (treated and stable mood disorders with score less than 6 allowed)
- Other clinically significant or unstable medical conditions that interfere with study participation
- Previous participation in 10 or more hours of computerized cognitive intervention in past two years
- Previous participation in cognitive intervention research at this site in past two years
- Planning to be unavailable for more than three weeks in the six months following screening
- Contraindications to MRI including pacemaker, metal implants, or claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
J
Jade Sutfin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here