Recruiting

Active Mind Trial

Sponsor:

University of Alabama at Birmingham

Code:

NCT04171323

Conditions

Age-related Cognitive Decline

Mild Cognitive Impairment

Dementia

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Cognitive Training

Computerized Cognitive Stimulation

Study Details

Brief summary:

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

Age-related Cognitive Decline

Mild Cognitive Impairment

Dementia

Study ID

NCT04171323

Start date

Mar 3, 2020

Status verified date

Dec, 2025

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

1305 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: CTa

Participants will complete computerized cognitive training. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.

experimental: CTab

Participants will complete computerized cognitive training. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.

experimental: CTac

Participants will complete computerized cognitive training. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.

experimental: CTabc

Participants will complete computerized cognitive training. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.

active comparator: Computerized Cognitive Stimulation

Participants will complete cognitively-stimulating computer activities. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.

Interventions

Cognitive Training

Participants will be completing a total of 40 computerized sessions.

Computerized Cognitive Stimulation

Participants will be completing a total of 40 computerized cognitive stimulation sessions.

Primary outcome measure

  • Dementia incidence [ Time Frame: At follow-up visit between 6 months to 2 years ]

Central Contacts and Locations

Central contacts

Jerri Edwards, PhD

864-916-6220activemindcoordinator@gmail.com

Jade Sutfin

864-916-6220activemindcoordinator@gmail.com

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Lana Callies

activemind@ucsf.edu

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Active Mind Study

Recruiting

Tampa, Florida, United States, 33617

Contacts

Active Mind Trial Coordinator

813-644-9374activemindstudy@gmail.com

Clemson University

Recruiting

Greenville, South Carolina, United States, 29607

Contacts

Active Mind Trial Coordinator

864-916-6220activemindstudy@gmail.com

Clemson University

Recruiting

Seneca, South Carolina, United States, 29672

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-12-11.