ACTIVE MIND: An Adaptive Clinical Trial of Cognitive Training to Improve Function and Delay Dementia
University of Alabama at Birmingham
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.
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 o…
Eligibility
- Age range
- 55–89 years
- Sex
- All
- Healthy volunteers
- No
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 day…
Interventions
- BehavioralCognitive Training
Participants will be completing a total of 40 computerized sessions.
- BehavioralComputerized Cognitive Stimulation
Participants will be completing a total of 40 computerized cognitive stimulation sessions.
Locations (6)
- University of California San FranciscoSan Francisco, California
- University of FloridaGainesville, Florida
- Active Mind StudyTampa, Florida
- University of MinnesotaMinneapolis, Minnesota
- Clemson UniversityGreenville, South Carolina
- Clemson UniversitySeneca, South Carolina