- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04171323
The Active Mind Trial: An Adaptive Randomized Trial to Improve Function and Delay Dementia
An Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia: The ACTIVE MIND Trial
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jerri Edwards, PhD
- Phone Number: 813.974.6703
- Email: usfcognitiveagelab@gmail.com
Study Contact Backup
- Name: Jade Sutfin
- Phone Number: 813.974.6703
- Email: usfcognitiveagelab@gmail.com
Study Locations
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California
-
San Francisco, California, United States, 94158
- Recruiting
- University of California San Francisco
-
Principal Investigator:
- Joel Kramer, PhD
-
Contact:
- Lana Callies
- Email: activemind@ucsf.edu
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-
Florida
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Gainesville, Florida, United States, 32611
- Recruiting
- University of Florida
-
Contact:
- Andrew O'Shea
-
Principal Investigator:
- Adam Woods, PhD
-
Sub-Investigator:
- Sam Wu, PhD
-
Sub-Investigator:
- Glenn Smith, PhD
-
Sub-Investigator:
- Steve DeKosky, MD
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Tampa, Florida, United States, 33620
- Recruiting
- University of South Florida
-
Principal Investigator:
- Jerri Edwards, PhD
-
Contact:
- Cognitive Aging Lab
- Phone Number: 813-974-6703
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Active, not recruiting
- University of Minnesota
-
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South Carolina
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Seneca, South Carolina, United States, 29672
- Recruiting
- Clemson University
-
Principal Investigator:
- Lesley A Ross, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Participants will be completing a total of 40 computerized 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.
|
Participants will be completing a total of 40 computerized 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.
|
Participants will be completing a total of 40 computerized 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.
|
Participants will be completing a total of 40 computerized 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.
|
Participants will be completing a total of 40 computerized cognitive stimulation sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dementia incidence
Time Frame: At follow-up visit between 6 months to 2 years
|
Clinical diagnosis of dementia
|
At follow-up visit between 6 months to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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
|
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
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
|
Useful Field of View test (UFOV) score across three subtests measured in milliseconds (ms).
Lower scores are better.
|
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
|
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.
|
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
|
The proprietary software calculates an overall executive function composite score using item response theory.
Higher scores are better
|
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood based biomarker Neurofilament light (Nfl)
Time Frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Effect sizes of between group differences will be calculated using linear contrasts.
|
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
Time Frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Effect sizes of between group differences will be calculated using linear contrast
|
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
Time Frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Effect sizes of between group differences will be calculated using linear contrasts.
|
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
blood based biomarker brain derived neurotropic factor (BDNF)
Time Frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Effect sizes of between group differences will be calculated using linear contrasts.
|
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
blood based biomarker insulin growth factor-1 (IGF-1), IGF binding protein-1 (IGFBP1) and IGFBP-2
Time Frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Effect sizes of between group differences will be calculated using linear contrasts.
|
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
blood based vascular biomarkers of asymmetric dimethylarginine [ADMA]; aspartic avid; acetyl-L-cartinine [C2]; butenyl-L-cartinine [C4:1]
Time Frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Effect sizes of between group differences will be calculated using linear contrasts.
|
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Neuroimaging MRI whole brain and regional volume
Time Frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Effect sizes of between group differences will be calculated using linear contrasts.
|
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Neuroimaging MRI surface area cortical thickness metrics from T1 weighted images
Time Frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Effect sizes of between group differences will be calculated using linear contrasts.
|
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Neuroimaging MRI whole brain and regional white matter hyper-intensity volume from FLAIR
Time Frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Effect sizes of between group differences will be calculated using linear contrasts.
|
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Neuroimaging MRI hippocampal subfield volume from high resolution hippocampal images
Time Frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Effect sizes of between group differences will be calculated using linear contrasts.
|
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Neuroimaging MRI regional and white matter metrics of fractional anisotropy from diffusion weighted imaging
Time Frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Effect sizes of between group differences will be calculated using linear contrasts.
|
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Neuroimaging MRI regional and white matter metrics of median diffusivity from diffusion weighted imaging
Time Frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Effect sizes of between group differences will be calculated using linear contrasts.
|
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Neuroimaging MRI regional and white matter metrics of radial diffusivity from diffusion weighted imaging
Time Frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Effect sizes of between group differences will be calculated using linear contrasts.
|
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Neuroimaging MRI regional and whole brain measures of cerebral perfusion from arterial spin labeling
Time Frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Effect sizes of between group differences will be calculated using linear contrasts.
|
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Neuroimaging MRI regional and whole brain cerebral microbleed volume from T2*GRE images
Time Frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Effect sizes of between group differences will be calculated using linear contrasts.
|
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Neuroimaging regional and network measures of functional connectivity for resting state fMRI
Time Frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Effect sizes of between group differences will be calculated using linear contrasts.
|
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Virtual Reality Functional Assessment Tool performance
Time Frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Measures may include Virtual Reality Functional Assessment Tool (VRFCAT) Effect sizes of between group differences will be calculated using linear contrasts.
|
change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jerri Edwards, PhD, University of South Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WIRB® Protocol #20192632
- R01AG075014 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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