RECRUITING

The Active Mind Trial: An Adaptive Randomized Trial to Improve Function and Delay Dementia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

ACTIVE MIND: An Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia

Quick Facts

Study Start:2020-03-03

Study Completion:2027-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04171323

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Jerri Edwards, PhD

CONTACT

864-916-6220

activemindcoordinator@gmail.com

Jade Sutfin

CONTACT

864-916-6220

activemindcoordinator@gmail.com

Principal Investigator

Jerri Edwards, PhD

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Study Locations (Sites)

University of California San Francisco

San Francisco, California, 94158

United States

University of Florida

Gainesville, Florida, 32611

United States

University of Minnesota

Minneapolis, Minnesota, 55455

United States

Clemson University

Seneca, South Carolina, 29672

United States

Collaborators and Investigators

Sponsor: University of South Florida

Jerri Edwards, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-03

Study Completion Date2027-08-31

Study Record Updates

Study Start Date2020-03-03

Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

Age-related Cognitive Decline
Mild Cognitive Impairment
Dementia