Elucidating the Necessary Active Components of Training
NCT ID: NCT05366023
Last Updated: 2022-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
280 participants
INTERVENTIONAL
2022-02-21
2024-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI
NCT02864069
The Active Mind Trial: An Adaptive Randomized Trial to Improve Function and Delay Dementia
NCT04171323
Effects of Exercise and Cognitive Training on Cognitive Function in Older Adults
NCT01038726
Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment
NCT01061489
The Effectiveness of Dual Task Training in Elderly With Cognitive Decline
NCT04689776
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
No contact
0 hours of activities during intervention period of study
No interventions assigned to this group
TDD1
10 hours of top-down driven cognitive training games
TDD1
10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking
TDD2
10 hours of top-down driven cognitive training games
TDD2
10 hours of top-down driven computerized cognitive training designed to improve executive function
TDD1 + TDD2
20 hours of top-down driven cognitive training games
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
BUD1
10 hours of bottom-up driven cognitive training games
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 cognitive training games
BUD2
10 hours of bottom-up driven computerized cognitive training designed to improve divided attention
BUD1 + BUD2
20 hours of bottom-up driven cognitive training games
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
BUD2 + TDD2
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
BUD2
10 hours of bottom-up driven computerized cognitive training designed to improve divided attention
TDD2
10 hours of top-down driven computerized cognitive training designed to improve executive function
BUD1 + TDD1
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
BUD1
10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention
TDD1
10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking
BUD2 + TDD1
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
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
BUD2 + TDD1 + TDD2
10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
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
BUD1 + TDD2
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
BUD1
10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention
TDD2
10 hours of top-down driven computerized cognitive training designed to improve executive function
BUD1 + TDD1 + TDD2
10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
BUD1
10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and 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
BUD1 + BUD2 + TDD2
20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
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
TDD2
10 hours of top-down driven computerized cognitive training designed to improve executive function
BUD1 + BUD2 + TDD1
20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
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
BUD1 + BUD2 + TDD1 + TDD2
20 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
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 cognitive stimulating activities
CSA10
10 hours of computerized games
CSA20
20 hours of cognitive stimulating activities
CSA20
20 hours of computerized games
CSA30
30 hours of cognitive stimulating activities
CSA30
30 hours of computerized games
CSA40
40 hours of cognitive stimulating activities
CSA40
40 hours of computerized games
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
55 Years
85 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Aging (NIA)
NIH
Penn State University
OTHER
University of Alabama at Birmingham
OTHER
Clemson University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clemson University Institute for Engaged Aging
Seneca, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.