Elucidating the Necessary Active Components of Training

Study Overview
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Brief Summary
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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.

Official Title
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Elucidating the Necessary Components and Mechanisms of Cognitive Training

Conditions
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Alzheimer Disease, Cognitive Change, Cognitive Impairment

Intervention / Treatment
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* Behavioral: BUD1
* Behavioral: BUD2
* Behavioral: TDD1
* Behavioral: TDD2
* Behavioral: CSA10
* Behavioral: CSA20
* Behavioral: CSA30
* Behavioral: CSA40


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No contact<br>0 hours of activities during intervention period of study | |
| Experimental: TDD1<br>10 hours of top-down driven cognitive training games | Behavioral: TDD1<br>* 10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking<br>|
| Experimental: TDD2<br>10 hours of top-down driven cognitive training games | Behavioral: TDD2<br>* 10 hours of top-down driven computerized cognitive training designed to improve executive function<br>|
| Experimental: TDD1 + TDD2<br>20 hours of top-down driven cognitive training games | Behavioral: TDD1<br>* 10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking<br>Behavioral: TDD2<br>* 10 hours of top-down driven computerized cognitive training designed to improve executive function<br>|
| Experimental: BUD1<br>10 hours of bottom-up driven cognitive training games | Behavioral: BUD1<br>* 10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention<br>|
| Experimental: BUD2<br>10 hours of bottom-up driven cognitive training games | Behavioral: BUD2<br>* 10 hours of bottom-up driven computerized cognitive training designed to improve divided attention<br>|
| Experimental: BUD1 + BUD2<br>20 hours of bottom-up driven cognitive training games | Behavioral: BUD1<br>* 10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention<br>Behavioral: BUD2<br>* 10 hours of bottom-up driven computerized cognitive training designed to improve divided attention<br>|
| Experimental: BUD2 + TDD2<br>10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games | Behavioral: BUD2<br>* 10 hours of bottom-up driven computerized cognitive training designed to improve divided attention<br>Behavioral: TDD2<br>* 10 hours of top-down driven computerized cognitive training designed to improve executive function<br>|
| Experimental: BUD1 + TDD1<br>10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games | Behavioral: BUD1<br>* 10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention<br>Behavioral: TDD1<br>* 10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking<br>|
| Experimental: BUD2 + TDD1<br>10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games | Behavioral: BUD2<br>* 10 hours of bottom-up driven computerized cognitive training designed to improve divided attention<br>Behavioral: TDD1<br>* 10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking<br>|
| Experimental: BUD2 + TDD1 + TDD2<br>10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games | Behavioral: BUD2<br>* 10 hours of bottom-up driven computerized cognitive training designed to improve divided attention<br>Behavioral: TDD1<br>* 10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking<br>Behavioral: TDD2<br>* 10 hours of top-down driven computerized cognitive training designed to improve executive function<br>|
| Experimental: BUD1 + TDD2<br>10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games | Behavioral: BUD1<br>* 10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention<br>Behavioral: TDD2<br>* 10 hours of top-down driven computerized cognitive training designed to improve executive function<br>|
| Experimental: BUD1 + TDD1 + TDD2<br>10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games | Behavioral: BUD1<br>* 10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention<br>Behavioral: TDD1<br>* 10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking<br>Behavioral: TDD2<br>* 10 hours of top-down driven computerized cognitive training designed to improve executive function<br>|
| Experimental: BUD1 + BUD2 + TDD2<br>20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games | Behavioral: BUD1<br>* 10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention<br>Behavioral: BUD2<br>* 10 hours of bottom-up driven computerized cognitive training designed to improve divided attention<br>Behavioral: TDD2<br>* 10 hours of top-down driven computerized cognitive training designed to improve executive function<br>|
| Experimental: BUD1 + BUD2 + TDD1<br>20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games | Behavioral: BUD1<br>* 10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention<br>Behavioral: BUD2<br>* 10 hours of bottom-up driven computerized cognitive training designed to improve divided attention<br>Behavioral: TDD1<br>* 10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking<br>|
| Experimental: BUD1 + BUD2 + TDD1 + TDD2<br>20 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games | Behavioral: BUD1<br>* 10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention<br>Behavioral: BUD2<br>* 10 hours of bottom-up driven computerized cognitive training designed to improve divided attention<br>Behavioral: TDD1<br>* 10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking<br>Behavioral: TDD2<br>* 10 hours of top-down driven computerized cognitive training designed to improve executive function<br>|
| Active Comparator: CSA10<br>10 hours of cognitive stimulating activities | Behavioral: CSA10<br>* 10 hours of computerized games<br>|
| Active Comparator: CSA20<br>20 hours of cognitive stimulating activities | Behavioral: CSA20<br>* 20 hours of computerized games<br>|
| Active Comparator: CSA30<br>30 hours of cognitive stimulating activities | Behavioral: CSA30<br>* 30 hours of computerized games<br>|
| Active Comparator: CSA40<br>40 hours of cognitive stimulating activities | Behavioral: CSA40<br>* 40 hours of computerized games<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protocol compliance | Participants complete laptop and phone activities as outlined in the study protocol | Baseline through 3 month follow-up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complex Instrumental Activities of Daily Living | Measures of everyday functioning as detailed in the study protocol | Baseline through 3 month follow-up visit |