The Active Mind Trial: Cognitive Training for Age-related Cognitive Decline, Mild Cognitive Impairment, and Dementia

This study, called The Active Mind Trial, is looking at different combinations of cognitive training (brain exercises) to help older adults who are at risk for dementia. You might be able to join if you are between 55 and 89 years old and have some changes in your thinking abilities, such as mild cognitive impairment (MCI). The study will compare different types of computerized cognitive training to see which combination is most effective at improving daily living skills and potentially delaying the onset of dementia. Participants will complete 40 computerized training sessions. The main goal is to see if these training programs can reduce the number of people who develop dementia over 6 months to 2 years.

Study design
This is an adaptive randomized trial comparing four different cognitive training programs to an active control group. The study plans to enroll 1305 participants.
What's involved
Participants will complete a total of 40 computerized cognitive training or cognitive stimulation sessions.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up for dementia incidence between 6 months and 2 years after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04171323

The Active Mind Trial: An Adaptive Randomized Trial to Improve Function and Delay Dementia

Recruiting
NAAges 55–89InterventionalPrevention
University of Alabama at Birmingham
~1,305 participants
Updated 2025-12-11 on ClinicalTrials.gov
What's tested:Cognitive TrainingComputerized Cognitive Stimulation

At a glance

Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dementia incidence
Measured over At follow-up visit between 6 months to 2 years
Age-related Cognitive Decline
Mild Cognitive Impairment
Dementia

NCT04171323

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Active Mind Study

    Tampa, Floridastudy coordinator listed

    Recruiting

  • Clemson University

    Greenville, South Carolinastudy coordinator listed

    Recruiting

  • University of California San Francisco

    San Francisco, Californiastudy coordinator listed

    Recruiting

  • Clemson University

    Seneca, South Carolinano site contact published

    Recruiting

  • University of Florida

    Gainesville, Floridano site contact published

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesotano site contact published

    Active, not recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Jerri Edwards, PhD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

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Eligibility criteria

Inclusion

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 and either 1) a CDR of 0.5; or 2) CDR of 0 and a clinical diagnosis of mild cognitive impairment (MCI) based on a multidisciplinary evaluation that included standardized neuropsychological testing
If reports use of medications typically prescribed for dementia such as Namenda, Memantine, Namzaric, Donepezil, Aricept, Rivastigmine, Exelon, Razadyne, Galantamine, or Reminyl, dose has been stable for at least 30 days
Adequate auditory capacity to understand normal speech. No greater than moderate hearing loss evident by thresholds less than or equal to 50 dB at 1000 and 2000 Hz in at least one ear determined by an audioscope.
Adequate visual capacity to read from a computer screen at a normal viewing distance as measured by binocular visual acuity of 20/50 or better tested with a standard near visual acuity chart
Reports and shows adequate motor capacity to touch a computer screen or control a computer mouse.
Wiling to complete all study activities
Willing and capable of providing informed consent
Ability to understand study procedures and comply with them for the length of the study

Exclusion

Currently enrolled in another randomized clinical trial, treatment trial, or another research study that assesses cognition
Dementia diagnosis
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 residual cognitive symptoms
History of brain tumor
Undergoing or plans to undergo surgery requiring anesthesia, chemotherapy, or radiation treatment in the six months following screening
Congestive heart failure diagnosis
Primary diagnosis of idiopathic Parkinson's disease
Multiple sclerosis or Amyotrophic lateral sclerosis (ALS) diagnosis
Evidence of a non-neurodegenerative neurological disorder that would interfere with the ability to carry out study activities.
Evidence of any other unstable medical conditions that would interfere with the ability to carry out study activities or cause fluctuations in cognition (e.g., unstable diabetes, chronic obstructive pulmonary disorder dependent on oxygen)
Geriatric Depression short scale score \>5/15. Participants with mood disorders that are treated and stable and have a GDS score \< 6/15 are not excluded.
Any other clinically significant or unstable medical condition (e.g., ongoing alcohol dependency or drug abuse, schizophrenia, psychosis) that in the assessor's opinion would interfere with the ability to carry out study activities.
Previous participation in 10 or more hours of a computerized cognitive intervention program in the past two years
Previous participation in cognitive intervention research at the study site in the past 2 years
Planning on going away or being otherwise unavailable for a period of more than three weeks in the six months following screening
Contraindications to MRI such as pacemaker, metal implants in body, or claustrophobia
  • Dementia incidenceAt follow-up visit between 6 months to 2 years

    Clinical diagnosis of dementia