Alzheimer DiseaseENACTNCT05366023
Elucidating the Necessary Active Components of Training
A study testing BUD1, BUD2 and TDD1 in people with Alzheimer Disease and Cognitive Change, run by Clemson University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Cognitive Change, Cognitive Impairment
- What is being tested?
- BUD1, BUD2 and TDD1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2022to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Clemson University Institute for Engaged Aging
Seneca, South Carolina, 29672
Jeremy Shields, MS, 864-916-6220, jnshiel@clemson.edu
About this study
Official title: Elucidating the Necessary Components and Mechanisms of Cognitive Training
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).
Read more
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
- Being tested
- BUD1, BUD2, TDD1, TDD2, CSA10
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BUD1Behavioural
10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention
BUD2Behavioural
10 hours of bottom-up driven computerized cognitive training designed to improve divided attention
TDD1Behavioural
10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking
TDD2Behavioural
10 hours of top-down driven computerized cognitive training designed to improve executive function
CSA10Behavioural
10 hours of computerized games
CSA20Behavioural
20 hours of computerized games
CSA30Behavioural
30 hours of computerized games
CSA40Behavioural
40 hours of computerized games
| Study group | Role | What they receive |
|---|---|---|
| No contact | No intervention | 0 hours of activities during intervention period of study |
| TDD1 | Experimental | 10 hours of top-down driven cognitive training games Receives: Behavioral: TDD1 |
| TDD2 | Experimental | 10 hours of top-down driven cognitive training games Receives: Behavioral: TDD2 |
| TDD1 + TDD2 | Experimental | 20 hours of top-down driven cognitive training games Receives: Behavioral: TDD1; Behavioral: TDD2 |
| BUD1 | Experimental | 10 hours of bottom-up driven cognitive training games Receives: Behavioral: BUD1 |
| BUD2 | Experimental | 10 hours of bottom-up driven cognitive training games Receives: Behavioral: BUD2 |
| BUD1 + BUD2 | Experimental | 20 hours of bottom-up driven cognitive training games Receives: Behavioral: BUD1; Behavioral: BUD2 |
| BUD2 + TDD2 | Experimental | 10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games Receives: Behavioral: BUD2; Behavioral: TDD2 |
| BUD1 + TDD1 | Experimental | 10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games Receives: Behavioral: BUD1; Behavioral: TDD1 |
| BUD2 + TDD1 | Experimental | 10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games Receives: Behavioral: BUD2; Behavioral: TDD1 |
| BUD2 + TDD1 + TDD2 | Experimental | 10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games Receives: Behavioral: BUD2; Behavioral: TDD1; Behavioral: TDD2 |
| BUD1 + TDD2 | Experimental | 10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games Receives: Behavioral: BUD1; Behavioral: TDD2 |
| BUD1 + TDD1 + TDD2 | Experimental | 10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games Receives: Behavioral: BUD1; Behavioral: TDD1; Behavioral: TDD2 |
| BUD1 + BUD2 + TDD2 | Experimental | 20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games Receives: Behavioral: BUD1; Behavioral: BUD2; Behavioral: TDD2 |
| BUD1 + BUD2 + TDD1 | Experimental | 20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games Receives: Behavioral: BUD1; Behavioral: BUD2; Behavioral: TDD1 |
| BUD1 + BUD2 + TDD1 + TDD2 | Experimental | 20 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games Receives: Behavioral: BUD1; Behavioral: BUD2; Behavioral: TDD1; Behavioral: TDD2 |
| CSA10 | Active comparator | 10 hours of cognitive stimulating activities Receives: Behavioral: CSA10 |
| CSA20 | Active comparator | 20 hours of cognitive stimulating activities Receives: Behavioral: CSA20 |
| CSA30 | Active comparator | 30 hours of cognitive stimulating activities Receives: Behavioral: CSA30 |
| CSA40 | Active comparator | 40 hours of cognitive stimulating activities Receives: Behavioral: CSA40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol compliance
Participants complete laptop and phone activities as outlined in the study protocol
Measured: Baseline through 3 month follow-up visit
Secondary outcomes (1)
Complex Instrumental Activities of Daily Living
Measures of everyday functioning as detailed in the study protocol
Measured: Baseline through 3 month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start21 Feb 2022
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clemson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Penn State University, University of Alabama at Birmingham
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366023
- Sponsor's protocol ID
- U01AG062370
- Other IDs
- U01AG062370
- Acronym
- ENACT
- Status last verified
- May 2022
- First submitted
- 4 May 2022
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Necessary Components and Mechanisms of Cognitive Training
- ClinicalTrials.gov ID
- NCT05366023
- Acronym / sponsor ID
- ENACT / U01AG062370
- Conditions
- Alzheimer Disease, Cognitive Change, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Clemson UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Penn State University, University of Alabama at Birmingham
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 20
| Arm | Type | Receives |
|---|---|---|
| No contact | No intervention | –0 hours of activities during intervention period of study |
| TDD1 | Experimental | Behavioral: TDD110 hours of top-down driven cognitive training games |
| TDD2 | Experimental | Behavioral: TDD210 hours of top-down driven cognitive training games |
| TDD1 + TDD2 | Experimental | Behavioral: TDD1, Behavioral: TDD220 hours of top-down driven cognitive training games |
| BUD1 | Experimental | Behavioral: BUD110 hours of bottom-up driven cognitive training games |
| BUD2 | Experimental | Behavioral: BUD210 hours of bottom-up driven cognitive training games |
| BUD1 + BUD2 | Experimental | Behavioral: BUD1, Behavioral: BUD220 hours of bottom-up driven cognitive training games |
| BUD2 + TDD2 | Experimental | Behavioral: BUD2, Behavioral: TDD210 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games |
| BUD1 + TDD1 | Experimental | Behavioral: BUD1, Behavioral: TDD110 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games |
| BUD2 + TDD1 | Experimental | Behavioral: BUD2, Behavioral: TDD110 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games |
| BUD2 + TDD1 + TDD2 | Experimental | Behavioral: BUD2, Behavioral: TDD1, Behavioral: TDD210 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games |
| BUD1 + TDD2 | Experimental | Behavioral: BUD1, Behavioral: TDD210 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games |
| BUD1 + TDD1 + TDD2 | Experimental | Behavioral: BUD1, Behavioral: TDD1, Behavioral: TDD210 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games |
| BUD1 + BUD2 + TDD2 | Experimental | Behavioral: BUD1, Behavioral: BUD2, Behavioral: TDD220 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games |
| BUD1 + BUD2 + TDD1 | Experimental | Behavioral: BUD1, Behavioral: BUD2, Behavioral: TDD120 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games |
| BUD1 + BUD2 + TDD1 + TDD2 | Experimental | Behavioral: BUD1, Behavioral: BUD2, Behavioral: TDD1, Behavioral: TDD220 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games |
| CSA10 | Active comparator | Behavioral: CSA1010 hours of cognitive stimulating activities |
| CSA20 | Active comparator | Behavioral: CSA2020 hours of cognitive stimulating activities |
| CSA30 | Active comparator | Behavioral: CSA3030 hours of cognitive stimulating activities |
| CSA40 | Active comparator | Behavioral: CSA4040 hours of cognitive stimulating activities |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Phase 1:
- Phase 2:
Key exclusion criteria (7 listed)
- Phase 1 exclusions:
- Phase 2 exclusion:
- Inability or unwillingness to travel to Clemson to provide two in-person blood samples at baseline and posttest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BUD110 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention | Behavioural | BUD1, BUD1 + BUD2, BUD1 + BUD2 + TDD1, BUD1 + BUD2 + TDD1 + TDD2, BUD1 + BUD2 + TDD2, BUD1 + TDD1, BUD1 + TDD1 + TDD2, BUD1 + TDD2 |
| BUD210 hours of bottom-up driven computerized cognitive training designed to improve divided attention | Behavioural | BUD1 + BUD2, BUD1 + BUD2 + TDD1, BUD1 + BUD2 + TDD1 + TDD2, BUD1 + BUD2 + TDD2, BUD2, BUD2 + TDD1, BUD2 + TDD1 + TDD2, BUD2 + TDD2 |
| TDD110 hours of top-down driven computerized cognitive training designed to improve multiple object tracking | Behavioural | BUD1 + BUD2 + TDD1, BUD1 + BUD2 + TDD1 + TDD2, BUD1 + TDD1, BUD1 + TDD1 + TDD2, BUD2 + TDD1, BUD2 + TDD1 + TDD2, TDD1, TDD1 + TDD2 |
| TDD210 hours of top-down driven computerized cognitive training designed to improve executive function | Behavioural | BUD1 + BUD2 + TDD1 + TDD2, BUD1 + BUD2 + TDD2, BUD1 + TDD1 + TDD2, BUD1 + TDD2, BUD2 + TDD1 + TDD2, BUD2 + TDD2, TDD1 + TDD2, TDD2 |
| CSA1010 hours of computerized games | Behavioural | CSA10 |
| CSA2020 hours of computerized games | Behavioural | CSA20 |
| CSA3030 hours of computerized games | Behavioural | CSA30 |
| CSA4040 hours of computerized games | Behavioural | CSA40 |
Primary outcome
Protocol compliance
Time frame: Baseline through 3 month follow-up visit
Participants complete laptop and phone activities as outlined in the study protocol
1 secondary outcome
Complex Instrumental Activities of Daily Living
Time frame: Baseline through 3 month follow-up visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BUD1, BUD2 and TDD1 in people with Alzheimer Disease and Cognitive Change, run by Clemson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lesley Ross, PhD (864-916-6220, Laross@clemson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protocol compliance (time frame: Baseline through 3 month follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.