Lifestyle Interventions for the Treatment of Early Onset Alzheimer's Disease Study
ConditionAlzheimer Disease, Early Onset
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorIndiana University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Training
DeviceParticipants will be asked to complete approximately 45 minutes of training, 4-5 sessions per week for 14 weeks (corresponding to approximately 40 hours of training total). Training will be completed via BrainHQ, a mobile application that, as used in this study, meets the FDA's definition of a medical device.
Tai Chi- Qi Gong
BehavioralParticipants will be asked to complete 14 hours of training total (in 30-minute sessions, 2 days per week for 14 weeks).
Brain Games
DeviceParticipants will be asked to complete 40 hours of training total (in 45-minute sessions, 4 to 5 days per week for 14 weeks). Training will be completed via BrainHQ, a mobile application that, as used in this study, meets the FDA's definition of a medical device.
Stretching
BehavioralParticipants will be asked to engage in stretching exercises twice per week, for approximately 20-30 minutes per session. This will total 14 hours over the course of 14 weeks.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Experimental Cognitive Training and Tai Chi- Qi Gong ArmExperimental treatment 2 interventions
Group B: Active Control ArmActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Performance on CANTAB Connect computerized Memory Composite immediately post-intervention, after controlling for baseline performance
CANTAB Connect computerized Memory Composite was selected for its remote assessment of memory, with validation in Alzheimer's Disease samples. This composite will be calculated from Paired Associates Learning, Pattern Recognition Memory, and Verbal Paired Associates subtests, with higher scores reflected better performance.
Time frame
15-Week Post-Intervention Follow-up2
Performance on CANTAB Connect computerized Executive Composite immediately post-intervention, after controlling for baseline performance
CANTAB Connect computerized Executive Composite was selected for its remote assessment of executive functioning, with validation in Alzheimer's Disease samples. This composite will be calculated from Stockings of Cambridge, Spatial Working Memory, Rapid Visual Processing, and Match To Sample subtests, with higher scores reflected better performance.
Time frame
15-Week Post-Intervention Follow-up3
Performance on CANTAB Connect computerized Memory Composite 26 weeks after intervention, after controlling for baseline performance
CANTAB Connect computerized Memory Composite was selected for its remote assessment of memory, with validation in Alzheimer's Disease samples. This composite will be calculated from Paired Associates Learning, Pattern Recognition Memory, and Verbal Paired Associates subtests, with higher scores reflected better performance.
Time frame
40-Week Post-Intervention Follow-up4
Performance on CANTAB Connect computerized Executive Composite 26 weeks after intervention, after controlling for baseline performance
CANTAB Connect computerized Executive Composite was selected for its remote assessment of executive functioning, with validation in Alzheimer's Disease samples. This composite will be calculated from Stockings of Cambridge, Spatial Working Memory, Rapid Visual Processing, and Match To Sample subtests, with higher scores reflected better performance.
Time frame
40-Week Post-Intervention Follow-upSecondary outcomes
1
Benefit from Cognitive Training using Cognitive Self-Report Questionnaire immediately post-intervention, after controlling for baseline performance
Cognitive Self-Report Questionnaire is a 25-item self-report questionnaire of subjective cognitive difficulties. Scores range from 0-125, with higher scores denoting greater cognitive symptoms. This measure has been used in a variety of studies examining benefit from cognitive training.
Time frame
15-Week Post-Intervention Follow-up2
Benefit from Cognitive Training using Cognitive Self-Report Questionnaire 26 weeks after intervention, after controlling for baseline performance
Cognitive Self-Report Questionnaire is a 25-item self-report questionnaire of subjective cognitive difficulties. Scores range from 0-125, with higher scores denoting greater cognitive symptoms. This measure has been used in a variety of studies examining benefit from cognitive training.
Time frame
40-Week Post-Intervention Follow-up3
Performance on scales of functioning immediately post-intervention, after controlling for baseline performance
The Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory is an informant-based rating scale that assesses the participant's ability to perform a variety of activities of daily living over the past four weeks, and has been shown to discriminate between healthy elderly controls and those with mild Alzheimer's disease. Scores range from 0-78, with higher scores denoting better functional ability.
Time frame
15-Week Post-Intervention Follow-up4
Performance on scales of functioning 26 weeks after intervention, after controlling for baseline performance
The Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory is an informant-based rating scale that assesses the participant's ability to perform a variety of activities of daily living over the past four weeks, and has been shown to discriminate between healthy elderly controls and those with mild Alzheimer's disease. Scores range from 0-78, with higher scores denoting better functional ability.
Time frame
40-Week Post-Intervention Follow-upSponsors and contacts
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Indiana University
Lead sponsor
Alzheimer's Association
Collaborator
Tai Chi Foundation
Collaborator
Alzheimer's Therapeutic Research Institute
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov