The Active Mind Trial: An Adaptive Randomized Trial to Improve Function and Delay Dementia
ACTIVE MIND: An Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia
2 other identifiers
interventional
1,305
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2019
CompletedFirst Posted
Study publicly available on registry
November 20, 2019
CompletedStudy Start
First participant enrolled
March 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
December 11, 2025
December 1, 2025
8.5 years
November 7, 2019
December 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Dementia incidence
Clinical diagnosis of dementia
At follow-up visit between 6 months to 2 years
Secondary Outcomes (5)
Useful Field of View Test performance overall score
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
Graduated continuous performance test score
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
Examiner Executive Function Set shifting, Anti-Saccades, and Flanker performance composite score
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
Timed IADL performance score
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
ifunction performance efficiency index
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
Other Outcomes (17)
blood based biomarker Neurofilament light (Nfl)
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
blood based biomarker Total tau
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
blood based biomarker hydroxsphingomyelins SM (OH) C22:1, SM (OH) C22:2, SM (OH) C24:1
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
- +14 more other outcomes
Study Arms (5)
CTa
EXPERIMENTALParticipants 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.
CTab
EXPERIMENTALParticipants 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.
CTac
EXPERIMENTALParticipants 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.
CTabc
EXPERIMENTALParticipants 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.
Computerized Cognitive Stimulation
ACTIVE COMPARATORParticipants 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
Participants will be completing a total of 40 computerized cognitive stimulation sessions.
Participants will be completing a total of 40 computerized sessions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscocollaborator
- University of Alabama at Birminghamlead
- University of Floridacollaborator
- University of Minnesotacollaborator
- National Institute on Aging (NIA)collaborator
- Clemson Universitycollaborator
Study Sites (6)
University of California San Francisco
San Francisco, California, 94158, United States
University of Florida
Gainesville, Florida, 32611, United States
Active Mind Study
Tampa, Florida, 33617, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Clemson University
Greenville, South Carolina, 29607, United States
Clemson University
Seneca, South Carolina, 29672, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jerri Edwards, PhD
University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 7, 2019
First Posted
November 20, 2019
Study Start
March 3, 2020
Primary Completion (Estimated)
August 31, 2028
Study Completion (Estimated)
August 31, 2028
Last Updated
December 11, 2025
Record last verified: 2025-12