Elucidating the Necessary Active Components of Training

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

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

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• Penn State University

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Clemson University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-02-21

Primary Completion

2024-02-29

Completion

2024-02-29

Countries

• United States

Study Locations