Age-related Cognitive DeclineNCT04171323
The Active Mind Trial: An Adaptive Randomized Trial to Improve Function and Delay Dementia
A study testing Cognitive Training and Computerized Cognitive Stimulation in people with Age-related Cognitive Decline and Mild Cognitive Impairment, run by University of Alabama at Birmingham at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 89 years
- Conditions the study is for
- Age-related Cognitive Decline, Mild Cognitive Impairment, Dementia
- What is being tested?
- Cognitive Training and Computerized Cognitive Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,305 participants
- Where
- 6 sitesUnited States
- Study dates
- 3 Mar 2020to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 5 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32611
Andrew O'Shea
Joseph Gullet, PhD
- Recruiting
Clemson University
Greenville, South Carolina, 29607
Active Mind Trial Coordinator, 864-916-6220, activemindstudy@gmail.com
- Active, not recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
- Recruiting
University of California San Francisco
San Francisco, California, 94158
Lana Callies, activemind@ucsf.edu
Joel Kramer, PhD
- Recruiting
Clemson University
Seneca, South Carolina, 29672
Lesley A Ross, PhD
- Recruiting
Active Mind Study
Tampa, Florida, 33617
Active Mind Trial Coordinator, 813-644-9374, activemindstudy@gmail.com
About this study
Official title: ACTIVE MIND: An Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia
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.
Read the detailed description
An Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia: The ACTIVE MIND Trial.
In the U01 phase, the primary objective 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). The longitudinal endpoint goal is delaying dementia onset.
The secondary objectives of the U01 phase were:
- To pilot test a plan to recruit and enroll under-represented minorities with the goal of obtaining a sample representative of the USF population in race and ethnicity.
In the current R01 phase:
The primary objective is to conduct 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). The longitudinal endpoint goal is reducing dementia incidence.
Design: The design is an adaptive randomized trial to identify the best combination of CT exercises to improve IADL function and thereby delay dementia onset among persons with MCI. Four arms of CT will be compared to an active control condition.
Outcomes: incident dementia is the primary outcome. Secondary outcome is Everyday Function: measures include Timed Instrumental Activities of Daily Living and iFunction. A composite of performance (measured by time and accuracy) will be derived.
Interventions and Duration: Four combinations of computerized cognitive training and an active control computerized stimulation will be investigated. The five arms will be equivalent in terms of frequency and duration of each session (60 min/day, two-three days/wk, 16 weeks).
Sample size: The study team plans to enroll up to 1305 participants. Individuals with a clinical diagnosis of MCI will be included in the study.
- Being tested
- Cognitive Training, Computerized Cognitive Stimulation
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
Participants will be completing a total of 40 computerized sessions.
Computerized Cognitive StimulationBehavioural
Participants will be completing a total of 40 computerized cognitive stimulation sessions.
| Study group | Role | What they receive |
|---|---|---|
| CTa | Experimental | 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. Receives: Behavioral: Cognitive Training |
| CTab | Experimental | 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. Receives: Behavioral: Cognitive Training |
| CTac | Experimental | 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. Receives: Behavioral: Cognitive Training |
| CTabc | Experimental | 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. Receives: Behavioral: Cognitive Training |
| Computerized Cognitive Stimulation | Active comparator | 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. Receives: Behavioral: Computerized Cognitive Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dementia incidence
Clinical diagnosis of dementia
Measured: At follow-up visit between 6 months to 2 years
Secondary outcomes (5)
Useful Field of View Test performance overall score
Useful Field of View test (UFOV) score across three subtests measured in milliseconds (ms). Lower scores are better.
Measured: 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
The metrics of performance are target accuracy (in percent correct) and the variability of responses (standard deviation of response times to target images). Higher scores are better.
Measured: 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
The proprietary software calculates an overall executive function composite score using item response theory. Higher scores are better
Measured: 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
A composite z score is calculated that reflects the overall time and accuracy of performance on the Timed IADL subtests per standard, published procedures (SPSS syntax of scoring method can be provided). Lower scores are better.
Measured: 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
An overall score reflecting time and accuracy (i.e., efficiency index) is calculated to reflect performance across the ifunction subtests the proprietary software determines the score. Higher scores are better for efficiency index
Measured: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start3 Mar 2020
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,305 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, University of Minnesota, National Institute on Aging (NIA), Clemson University, University of California, San Francisco
- Responsible party
- Principal investigator, Jerri Edwards, University of Alabama at Birmingham
- Investigators
- Jerri Edwards, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171323
- Sponsor's protocol ID
- WIRB® Protocol #20192632
- Other IDs
- R01AG075014
- Status last verified
- Dec 2025
- First submitted
- 7 Nov 2019
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACTIVE MIND: An Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia
- ClinicalTrials.gov ID
- NCT04171323
- Acronym / sponsor ID
- WIRB® Protocol #20192632
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,305 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University of Florida, University of Minnesota, National Institute on Aging (NIA), Clemson University, University of California, San Francisco
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia: The ACTIVE MIND Trial.
In the U01 phase, the primary objective 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). The longitudinal endpoint goal is delaying dementia onset.
The secondary objectives of the U01 phase were:
- To pilot test a plan to recruit and enroll under-represented minorities with the goal of obtaining a sample representative of the USF population in race and ethnicity.
In the current R01 phase:
The primary objective is to conduct 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). The longitudinal endpoint goal is reducing dementia incidence.
Design: The design is an adaptive randomized trial to identify the best combination of CT exercises to improve IADL function and thereby delay dementia onset among persons with MCI. Four arms of CT will be compared to an active control condition.
Outcomes: incident dementia is the primary outcome. Secondary outcome is Everyday Function: measures include Timed Instrumental Activities of Daily Living and iFunction. A composite of performance (measured by time and accuracy) will be derived.
Interventions and Duration: Four combinations of computerized cognitive training and an active control computerized stimulation will be investigated. The five arms will be equivalent in terms of frequency and duration of each session (60 min/day, two-three days/wk, 16 weeks).
Sample size: The study team plans to enroll up to 1305 participants. Individuals with a clinical diagnosis of MCI will be included in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CTa | Experimental | Behavioral: Cognitive TrainingParticipants 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 | Experimental | Behavioral: Cognitive TrainingParticipants 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 | Experimental | Behavioral: Cognitive TrainingParticipants 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 | Experimental | Behavioral: Cognitive TrainingParticipants 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 comparator | Behavioral: Computerized Cognitive StimulationParticipants 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. |
Who may qualify
- Ages
- 55 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive TrainingParticipants will be completing a total of 40 computerized sessions. | Behavioural | CTa, CTab, CTabc, CTac |
| Computerized Cognitive StimulationParticipants will be completing a total of 40 computerized cognitive stimulation sessions. | Behavioural | Computerized Cognitive Stimulation |
Primary outcome
Dementia incidence
Time frame: At follow-up visit between 6 months to 2 years
Clinical diagnosis of dementia
5 secondary outcomes
Useful Field of View Test performance overall score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
Related trials for Age-related Cognitive Decline
RecruitingPhase 1
Acute Effects of THC in Older Adult
Age-related Cognitive Decline
Recruiting
Epigenetic Enhancement of Cognitive Training in Aging Mood and Schizophrenia Spectrum Disorder Populations
Bipolar Disorder (BD), Depression - Major Depressive Disorder
Active, not recruitingObservational study
The Dortmund Vital Study: Impact of Biological and Lifestyle Factors on Cognitive Performace and Work Ability
Age-related Cognitive Decline
RecruitingObservational study
Older Breast Cancer Patients: Risk for Cognitive Decline
Cancer, Breast, Age-related Cognitive Decline
Recruiting
Health Ahead Comparative Effectiveness Study
Health Services Accessibility, Rural Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jerri Edwards, PhD principal investigator
University of Alabama at Birmingham
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training and Computerized Cognitive Stimulation in people with Age-related Cognitive Decline and Mild Cognitive Impairment, run by University of Alabama at Birmingham at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jerri Edwards, PhD (864-916-6220, activemindcoordinator@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dementia incidence (time frame: At follow-up visit between 6 months to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.