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

NCT05573490 | Recruiting DMC FDA Device

• 3 other identifiers: 14594AARG-22-9269401K23AG080071-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease, Early Onset

Keywords

lifestyle intervention; cognitive training; exercise training; cognition

Outcome Measures

Primary Outcomes (4)

• 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.

  15-Week Post-Intervention Follow-up

• 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.

  15-Week Post-Intervention Follow-up

• 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.

  40-Week Post-Intervention Follow-up

• 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.

  40-Week Post-Intervention Follow-up

Secondary Outcomes (12)

• Benefit from Cognitive Training using Cognitive Self-Report Questionnaire immediately post-intervention, after controlling for baseline performance

  15-Week Post-Intervention Follow-up

• Benefit from Cognitive Training using Cognitive Self-Report Questionnaire 26 weeks after intervention, after controlling for baseline performance

  40-Week Post-Intervention Follow-up

• Performance on scales of functioning immediately post-intervention, after controlling for baseline performance

  15-Week Post-Intervention Follow-up

• Performance on scales of functioning 26 weeks after intervention, after controlling for baseline performance

  40-Week Post-Intervention Follow-up

• Self-reported depression immediately post-intervention, after controlling for baseline performance

  15-Week Post-Intervention Follow-up

Study Arms (2)

Experimental Cognitive Training and Tai Chi- Qi Gong Arm

EXPERIMENTAL

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

Device: Cognitive Training; Behavioral: Tai Chi- Qi Gong

Active Control Arm

ACTIVE COMPARATOR

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

Device: Brain Games; Behavioral: Stretching

Interventions

Cognitive Training DEVICE

Participants 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.

Also known as: BrainHQ

Experimental Cognitive Training and Tai Chi- Qi Gong Arm

Tai Chi- Qi Gong BEHAVIORAL

Participants will be asked to complete 14 hours of training total (in 30-minute sessions, 2 days per week for 14 weeks).

Experimental Cognitive Training and Tai Chi- Qi Gong Arm

Brain Games DEVICE

Participants 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.

Also known as: BrainHQ

Active Control Arm

Stretching BEHAVIORAL

Participants 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.

Active Control Arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• Alzheimer's Association: collaborator
• Tai Chi Foundation: collaborator
• Alzheimer's Therapeutic Research Institute: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Dustin B Hammers, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dustin B Hammers, PhD

CONTACT

3179638557; hammersd@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant and outcomes assessor (study coordinator) will be masked to intervention assignment. Principle investigator will not be masked given the size of the study team.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized into one of two conditions: (1) Computerized Cognitive Training + Tai Chi Exercise or (2) Active Control.

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 10, 2022
• Study Start: January 11, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)