Lifestyle Interventions for the Treatment of Early Onset Alzheimer's Disease Study (LITES)

Indiana University

Status: Enrolling

Conditions: Alzheimer Disease, Early Onset

Treatments: Behavioral: Tai Chi- Qi Gong; Device: Cognitive Training; Behavioral: Stretching; Device: Brain Games

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05573490

14594

AARG-22-926940 (Other Grant/Funding Number)

1K23AG080071-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups

Experimental Cognitive Training and Tai Chi- Qi Gong Arm

Experimental group

Description:

Participants receiving 14 weeks of Cognitive Training (BrainHQ) and Tai Chi- Qi Gong exercise training

Treatment:

Device: Cognitive Training

Behavioral: Tai Chi- Qi Gong

Active Control Arm

Active Comparator group

Description:

Participants receiving 14 weeks of Brain Games (BrainHQ) and stretching

Treatment:

Behavioral: Stretching

Device: Brain Games