Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Active Mind Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04171323
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : January 6, 2020
Sponsor:
Collaborators:
University of Florida
University of California, San Francisco
University of Minnesota
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Jerri D. Edwards, University of South Florida

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 is 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 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 the effects of CT on neuroimaging and novel blood-based biomarker outcomes.

Condition or disease Intervention/treatment Phase
Age-related Cognitive Decline Mild Cognitive Impairment Dementia Behavioral: Cognitive Training Behavioral: Computerized Cognitive Stimulation Not Applicable

Detailed Description:

Planning an Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia: The ACTIVE MIND Trial.

The primary objective is 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 are:

  • 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.
  • To explore blood-based biomarkers as outcomes of CT
  • To explore change in the Alzheimer's Disease Neuroimaging Initiative 3 (ADNI-3) MRI protocol for neuroimaging to quantify brain structure, white matter hyperintensities (WMH), hippocampal size, cerebral microbleed and perfusion, white matter integrity, and resting state function as an effect of CT interventions.

With additional funding and extension of the study:

  • To examine the efficacy of promising combinations of CT exercises to modify functional trajectories in MCI
  • To examine the efficacy of promising combinations of CT to delay dementia onset

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: Determine which combinations of CT are efficacious to improve IADL performance, and thereby most likely to delay dementia onset.

Everyday Function measures will include: Timed Instrumental Activities of Daily Living and iFunction. A composite of performance (measured by time and accuracy) will be derived from principal component analyses.

Cognition measures will include: Useful Field of View test (UFOV), Graduated Continuous Performance Test (gradCPT), and Examiner. A composite will be derived from principal component analyses.

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: In-person screening of 100 potential study participants are planned to enroll up to 60 participants. The goal is to have at least 60 participants complete the study. Individuals with a clinical diagnosis of MCI will be included in the study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Planning an Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia: The ACTIVE MIND Trial
Actual Study Start Date : January 2, 2020
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

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.
Behavioral: Cognitive Training
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.
Behavioral: Cognitive Training
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.
Behavioral: Cognitive Training
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.
Behavioral: Cognitive Training
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.
Behavioral: Computerized Cognitive Stimulation
Participants will be completing a total of 40 computerized cognitive stimulation sessions.




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Other Outcome Measures:
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171323


Contacts
Layout table for location contacts
Contact: Jerri Edwards, PhD 813.974.6703 usfcognitiveagelab@gmail.com
Contact: Jade Sutfin 813.974.6703 usfcognitiveagelab@gmail.com

Locations
Layout table for location information
United States, California
University of California San Francisco Not yet recruiting
San Francisco, California, United States, 94158
Contact: Michelle You         
Principal Investigator: Joel Kramer, PhD         
United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Andrew O'Shea         
Principal Investigator: Adam Woods, PhD         
Sub-Investigator: Sam Wu, PhD         
Sub-Investigator: Glenn Smith, PhD         
Sub-Investigator: Steve DeKosky, MD         
University of South Florida Recruiting
Tampa, Florida, United States, 33620
Contact: Cognitive Aging Lab    813-974-6703      
Principal Investigator: Jerri Edwards, PhD         
United States, Minnesota
University of Minnesota Active, not recruiting
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of South Florida
University of Florida
University of California, San Francisco
University of Minnesota
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Jerri Edwards, PhD University of South Florida
Layout table for additonal information
Responsible Party: Jerri D. Edwards, Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT04171323    
Other Study ID Numbers: WIRB® Protocol #20192632
U01AG062368 ( U.S. NIH Grant/Contract )
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders