Elucidating the Necessary Active Components of Training

Alzheimer Disease Clinical Trial

— ENACT  

Official title:

Elucidating the Necessary Components and Mechanisms of Cognitive Training

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05366023
• Other study ID #: U01AG062370
• Secondary ID: U01AG062370
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2022
• Est. completion date: February 2024

Study information

• Verified date: May 2022
• Source: Clemson University
• Contact: Lesley Ross, PhD
• Phone: 864-916-6220
• Email: Laross[@]clemson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Change
• Cognitive Impairment

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Clemson University Institute for Engaged Aging	Seneca	South Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Clemson University	National Institute on Aging (NIA), Penn State University, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protocol compliance	Participants complete laptop and phone activities as outlined in the study protocol	Baseline through 3 month follow-up visit
Secondary	Complex Instrumental Activities of Daily Living	Measures of everyday functioning as detailed in the study protocol	Baseline through 3 month follow-up visit