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Cognitive Training for Alzheimer's Disease (ENACT Trial)

N/A
Recruiting
Research Sponsored by Clemson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Phase 1: Age 55-85 community-dwelling adults
Phase 1: No reported evidence of or diagnosis of dementia/Alzheimer's Disease; score of 5 or greater on the MIS-t administered during phone screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 3 month follow-up visit
Awards & highlights

ENACT Trial Summary

This trial will explore the effects of two forms of cognitive training on older adults, including cognitive, psychosocial, and lifestyle measures, as well as biomarkers. The study will also examine how cognitive and psychosocial factors within daily life account for the transfer of cognitive training to everyday function.

Who is the study for?
Adults aged 55-85 who live in the community, can communicate in English, and are willing to commit up to 9 months. They must not have dementia or Alzheimer's Disease, use video games more than 2 hours a week recently, or be engaged in other cognitive programs. For Phase 2, they also need to provide blood samples.Check my eligibility
What is being tested?
The trial is testing different amounts of cognitive training (0,10,20,30 or 40 hours) on maintaining cognition and daily function among older adults. It uses a factorial design for randomization and includes follow-up assessments using laptops and smartphones provided by the study.See study design
What are the potential side effects?
Since this is a noninvasive cognitive training intervention rather than medication-based treatment there may not be traditional side effects; however participants might experience fatigue or frustration during the exercises.

ENACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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People who are 55 to 85 years old and live independently in the community.
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You do not have dementia or Alzheimer's disease, and you scored 5 or higher on a phone screening test for memory issues.

ENACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 3 month follow-up visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 3 month follow-up visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Protocol compliance
Secondary outcome measures
Complex Instrumental Activities of Daily Living

ENACT Trial Design

20Treatment groups
Experimental Treatment
Active Control
Group I: TDD2Experimental Treatment1 Intervention
10 hours of top-down driven cognitive training games
Group II: TDD1 + TDD2Experimental Treatment2 Interventions
20 hours of top-down driven cognitive training games
Group III: TDD1Experimental Treatment1 Intervention
10 hours of top-down driven cognitive training games
Group IV: BUD2 + TDD2Experimental Treatment2 Interventions
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Group V: BUD2 + TDD1 + TDD2Experimental Treatment3 Interventions
10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
Group VI: BUD2 + TDD1Experimental Treatment2 Interventions
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Group VII: BUD2Experimental Treatment1 Intervention
10 hours of bottom-up driven cognitive training games
Group VIII: BUD1 + TDD2Experimental Treatment2 Interventions
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Group IX: BUD1 + TDD1 + TDD2Experimental Treatment3 Interventions
10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
Group X: BUD1 + TDD1Experimental Treatment2 Interventions
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Group XI: BUD1 + BUD2 + TDD2Experimental Treatment3 Interventions
20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Group XII: BUD1 + BUD2 + TDD1 + TDD2Experimental Treatment4 Interventions
20 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
Group XIII: BUD1 + BUD2 + TDD1Experimental Treatment3 Interventions
20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Group XIV: BUD1 + BUD2Experimental Treatment2 Interventions
20 hours of bottom-up driven cognitive training games
Group XV: BUD1Experimental Treatment1 Intervention
10 hours of bottom-up driven cognitive training games
Group XVI: CSA40Active Control1 Intervention
40 hours of cognitive stimulating activities
Group XVII: CSA10Active Control1 Intervention
10 hours of cognitive stimulating activities
Group XVIII: CSA20Active Control1 Intervention
20 hours of cognitive stimulating activities
Group XIX: CSA30Active Control1 Intervention
30 hours of cognitive stimulating activities
Group XX: No contactActive Control1 Intervention
0 hours of activities during intervention period of study

Find a Location

Who is running the clinical trial?

Clemson UniversityLead Sponsor
33 Previous Clinical Trials
5,613 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,655 Previous Clinical Trials
28,003,890 Total Patients Enrolled
Penn State UniversityOTHER
353 Previous Clinical Trials
125,444 Total Patients Enrolled

Media Library

BUD1 Clinical Trial Eligibility Overview. Trial Name: NCT05366023 — N/A
Cognitive Impairment Research Study Groups: BUD1, BUD2, BUD1 + TDD1, CSA40, TDD1, BUD1 + TDD2, BUD1 + BUD2 + TDD2, CSA10, BUD1 + BUD2 + TDD1, BUD1 + TDD1 + TDD2, BUD1 + BUD2 + TDD1 + TDD2, BUD2 + TDD1, BUD2 + TDD1 + TDD2, CSA20, CSA30, TDD1 + TDD2, BUD2 + TDD2, No contact, BUD1 + BUD2, TDD2
Cognitive Impairment Clinical Trial 2023: BUD1 Highlights & Side Effects. Trial Name: NCT05366023 — N/A
BUD1 2023 Treatment Timeline for Medical Study. Trial Name: NCT05366023 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the enrollment criteria for this clinical trial encompass individuals beyond 60 years of age?

"This clinical trial is admitting participants aged between 55 and 85 years old."

Answered by AI

What qualifications must prospective participants have to enroll in this medical experiment?

"This clinical trial seeks 280 elderly individuals, aged 55 to 85 years old, who are currently diagnosed with Alzheimer's disease. Eligible participants must also demonstrate written comprehension and oral fluency in English; have obtained consent forms; scored 5 or higher on an MIS-t administered during phone screening; and be willing to provide two blood samples at baseline and posttest over the course of nine months."

Answered by AI

What is the ceiling on patient participation for this investigative endeavor?

"Affirmative. According to clinicaltrials.gov, this study is currently accepting enrolment applications; its initial post date was February 21st 2022 and it was last updated on May 4th 2022. The medical trial requires 280 participants at a single research centre."

Answered by AI

Are there any opportunities to enroll in this trial at present?

"The clinical data available on clinicialtrials.gov confirms that this research project is actively recruiting participants. It was first made public on February 21st 2022 and has since been updated as of May 4th 2022."

Answered by AI
~91 spots leftby Mar 2025