NCT05366023

Elucidating the Necessary Active Components of Training

Elucidating the Necessary Components and Mechanisms of Cognitive Training

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Clemson University · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Loss of independence, cognitive decline, and difficulties in everyday function are areas of great concern for older adults and their families. Cognitive training is one low cost, noninvasive training intervention that has repeatedly demonstrated reliable transfer effects to maintained cognition, everyday function, health, and most recently, a 29% reduction in incident dementia. Importantly, many of these everyday function effects are maintained across five to ten years including: maintained driving mobility, 50% reduction in at-fault vehicle crashes, and maintained Instrumental Activities of Daily Living (IADL). Although clearly an important and effective intervention, the moderators and mechanisms underlying this program are unknown. The overall objective in this planning grant is to lay the conceptual and methodological foundation to explore cognitive, psychosocial, lifestyle behaviors, and biomarker mechanisms and moderators of two forms of conceptually driven cognitive training. Additionally, this study will examine how cognitive and psychosocial factors within daily life account for the transfer of cognitive training to everyday function. We will use a factorial design to randomize adults ages 55-85 to 0, 10, 20, 30, or 40 hours of two forms of cognitive training, a combined training, or an active comparison condition (Phase 1). An additional sample of participants will complete 20 hours of two forms of cognitive training or the active comparison group as well as provide blood samples (Phase 2). Across the study period, participants will complete cognitive, health, lifestyle, and psychosocial assessments at baseline, posttest, and approximately three month follow-up assessments in person or remotely using a study-provided laptop. Additionally, all participants will be asked to complete daily cognitive, health, lifestyle, and psychosocial measures daily using study-provided smartphones. This study will allow us to test the feasibility of our enrollment, assessment and training protocols for a future multisite clinical trial. This exploratory study is the first of its kind and will be used to provide important data relevant to a future larger randomized controlled trial examining mediators of cognitive training in a representative sample of adults. This information will assist in the future development of more effective home- and community-based interventions that maintain everyday function.

Conditions

• Alzheimer Disease
• Cognitive Change
• Cognitive Impairment

Interventions

Type	Name	Description
BEHAVIORAL	BUD1	10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention
BEHAVIORAL	BUD2	10 hours of bottom-up driven computerized cognitive training designed to improve divided attention
BEHAVIORAL	TDD1	10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking
BEHAVIORAL	TDD2	10 hours of top-down driven computerized cognitive training designed to improve executive function
BEHAVIORAL	CSA10	10 hours of computerized games
BEHAVIORAL	CSA20	20 hours of computerized games
BEHAVIORAL	CSA30	30 hours of computerized games
BEHAVIORAL	CSA40	40 hours of computerized games

Timeline

• Start date: 2022-02-21
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2022-05-09
• Last updated: 2022-05-09

Locations

1 site across 1 country: United States