Recruiting

Observational Study

Sponsor:

Clemson University

Code:

NCT05366023

Conditions

Alzheimer Disease

Cognitive Change

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

Interventions

BUD1

BUD2

TDD1

TDD2

CSA10

Study Details

Brief 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

Study ID

NCT05366023

Start date

Feb 21, 2022

Status verified date

May, 2022

Completion date

Feb, 2024

Anticipated

Primary completion date

Feb, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Phase 1:

  • Age 55-85 community-dwelling adults
  • Written informed consent obtained
  • No reported evidence of or diagnosis of dementia/Alzheimer's Disease; score of 5 or greater on the MIS-t administered during phone screening
  • Willing and able to participate in the up to 9 months of the study duration
  • Is proficient in written and spoken English
  • Phase 2:

  • All Phase 1 criteria plus willingness and ability to provide two blood samples at baseline and posttest

Exclusion Criteria:

  • Phase 1 exclusions:

  • Failure to meet any of the above eligibility criteria
  • Use of video games for more than 2 hours/week over the previous 2 years
  • Currently engaged in a cognitive program such as Brain HQ or Lumosity
  • Phase 2 exclusion:

In addition to Phase 1 exclusion, also criteria below:

• Inability or unwillingness to travel to Clemson to provide two in-person blood samples at baseline and posttest

Study Design

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: No contact

0 hours of activities during intervention period of study

experimental: TDD1

10 hours of top-down driven cognitive training games

experimental: TDD2

10 hours of top-down driven cognitive training games

experimental: TDD1 + TDD2

20 hours of top-down driven cognitive training games

experimental: BUD1

10 hours of bottom-up driven cognitive training games

experimental: BUD2

10 hours of bottom-up driven cognitive training games

experimental: BUD1 + BUD2

20 hours of bottom-up driven cognitive training games

experimental: BUD2 + TDD2

10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games

experimental: BUD1 + TDD1

10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games

experimental: BUD2 + TDD1

10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games

experimental: BUD2 + TDD1 + TDD2

10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games

experimental: BUD1 + TDD2

10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games

experimental: BUD1 + TDD1 + TDD2

10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games

experimental: BUD1 + BUD2 + TDD2

20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games

experimental: BUD1 + BUD2 + TDD1

20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games

experimental: BUD1 + BUD2 + TDD1 + TDD2

20 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games

active comparator: CSA10

10 hours of cognitive stimulating activities

active comparator: CSA20

20 hours of cognitive stimulating activities

active comparator: CSA30

30 hours of cognitive stimulating activities

active comparator: CSA40

40 hours of cognitive stimulating activities

Interventions

BUD1

10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention

BUD2

10 hours of bottom-up driven computerized cognitive training designed to improve divided attention

TDD1

10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking

TDD2

10 hours of top-down driven computerized cognitive training designed to improve executive function

CSA10

10 hours of computerized games

CSA20

20 hours of computerized games

CSA30

30 hours of computerized games

CSA40

40 hours of computerized games

Primary outcome measure

  • Protocol compliance [ Time Frame: Baseline through 3 month follow-up visit ]

Central Contacts and Locations

Central contacts

Locations

Clemson University Institute for Engaged Aging

Recruiting

Seneca, South Carolina, United States, 29672

Contacts

More Information

Sponsor

Clemson University

Last update posted

May 9, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Clemson University on 2022-05-09.