Clinical trial NCT05573490: Lifestyle Interventions for the Treatment of Early Onset Alzheimer's Disease Study
Official title: Lifestyle Interventions for the Treatment of Early Onset Alzheimer's Disease Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease, Early Onset
Keywords: lifestyle intervention
cognitive training
exercise training
cognition
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
name: Tai Chi Foundation
name: Alzheimer's Therapeutic Research Institute
name: National Institute on Aging (NIA)
First posted: 2022-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into one of two conditions: (1) Computerized Cognitive Training + Tai Chi Exercise or (2) Active Control.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to generate preliminary data on the benefit of computerized cognitive training and Tai Chi- Qi Gong training in participants with Early-Onset Alzheimer's Disease. It is hypothesized that participants in the experimental training condition will perform better on outcomes related to cognition, functioning, and mood at follow-up compared to participants assigned to the active control condition.

Detailed description: This study aims to generate preliminary data regarding the efficacy of a combined cognitive-training and Tai Chi- Qi Gong exercise lifestyle intervention in participants diagnosed with Early-Onset Alzheimer's Disease (EOAD). Participants will complete a series of cognitive, functional, and mood assessments at a remotely-assessed baseline visit, and then be randomized into one of two conditions: (1) Computerized Cognitive Training + Tai Chi Exercise or (2) Active Control. Outcome measures will be repeated immediately Post-Treatment and at 6-months post-treatment Follow-Up. Specific Aim 1 will examine the feasibility of this lifestyle intervention and outcome assessments when applied to participants with EOAD. Specific Aim 2 will investigate if this lifestyle intervention improves short- and long-term cognition, functioning, and mood. Specific Aim 3 will be exploratory to assess whether individual differences in training or clinical/ demographic characteristics moderate the degree of benefit from this intervention; owing to sample size limitations in this feasibility study, focus of this latter aim will be on determining effect sizes and sample-size magnitude needed for future work.

Eligibility criteria: Inclusion Criteria:

* Enrolled in the Longitudinal Early-Onset AD Study (LEADS) parent study, and being classified via LEADS consensus criteria as having amyloid-positive Early Onset Alzheimer's Disease
* Aged 40-64 years at the time of enrollment into LEADS
* Fluent in English
* In good general health and absent another neurological disorder
* Have a knowledgeable informant.
* Have had a Clinical Dementia Rating scale of 0.5 to 1.0 at the time of enrollment into LEADS
* Have sufficient vision, hearing, comprehension, and manual dexterity to participate in the testing and training program

Exclusion Criteria:

• Have access to the internet (e.g., home, family, public library, etc.) for less than 4 hours per week

Primary outcomes:
measure: Performance on CANTAB Connect computerized Memory Composite immediately post-intervention, after controlling for baseline performance
timeFrame: 15-Week Post-Intervention Follow-up
measure: Performance on CANTAB Connect computerized Executive Composite immediately post-intervention, after controlling for baseline performance
timeFrame: 15-Week Post-Intervention Follow-up
measure: Performance on CANTAB Connect computerized Memory Composite 26 weeks after intervention, after controlling for baseline performance
timeFrame: 40-Week Post-Intervention Follow-up
measure: Performance on CANTAB Connect computerized Executive Composite 26 weeks after intervention, after controlling for baseline performance
timeFrame: 40-Week Post-Intervention Follow-up
Secondary outcomes:
measure: Benefit from Cognitive Training using Cognitive Self-Report Questionnaire immediately post-intervention, after controlling for baseline performance
timeFrame: 15-Week Post-Intervention Follow-up
measure: Benefit from Cognitive Training using Cognitive Self-Report Questionnaire 26 weeks after intervention, after controlling for baseline performance
timeFrame: 40-Week Post-Intervention Follow-up
measure: Performance on scales of functioning immediately post-intervention, after controlling for baseline performance
timeFrame: 15-Week Post-Intervention Follow-up
measure: Performance on scales of functioning 26 weeks after intervention, after controlling for baseline performance
timeFrame: 40-Week Post-Intervention Follow-up
measure: Self-reported depression immediately post-intervention, after controlling for baseline performance
timeFrame: 15-Week Post-Intervention Follow-up
measure: Self-reported depression 26 weeks after intervention, after controlling for baseline performance
timeFrame: 40-Week Post-Intervention Follow-up
measure: Self-reported quality of life immediately post-intervention, after controlling for baseline performance
timeFrame: 15-Week Post-Intervention Follow-up
measure: Self-reported quality of life 26 weeks after intervention, after controlling for baseline performance
timeFrame: 40-Week Post-Intervention Follow-up
measure: Self-reported stress immediately post-intervention, after controlling for baseline performance
timeFrame: 15-Week Post-Intervention Follow-up
measure: Self-reported stress 26 weeks after intervention, after controlling for baseline performance
timeFrame: 40-Week Post-Intervention Follow-up
measure: Self-reported perceived social support immediately post-intervention, after controlling for baseline performance
timeFrame: 15-Week Post-Intervention Follow-up
measure: Self-reported perceived social support 26 weeks after intervention, after controlling for baseline performance
timeFrame: 40-Week Post-Intervention Follow-up
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Dustin B Hammers, PhD
role: PRINCIPAL_INVESTIGATOR
References: