NCT04732182

Telerehabilitation Alzheimer's Disease Feasibility (TADF)

Telerehabilitation Combining Virtual Reality Adaptable Games and Drug Therapy for Early Alzheimer's Disease - Feasibility

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Bright Cloud International Corp · Industry
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is a pilot RCT with equal arms: experimental arm and (wait list) control arm. All participants will be in the early stage of Alzheimer's disease and on stable medication. They will all continue with this medication for their 6 months participation. Experimental group will add weekly training on the experimental device, 5 days a week for 8 weeks. Training will involve therapeutic games aimed primarily at the memory cognitive domain. All participants will receive weekly calls from clinical coordinator and report on medication and overall health. Caregivers will also be enrolled so they support the trials.

Detailed description

Participants will be randomized equally into an experimental group and a wait list control group. Experimental training will occur in the home, and will last 8 weeks, each week having 5 sessions of therapeutic game play. Each session will start with vitals being measured and logged followed by motor and biosensor baselines. Subsequently, participants will play an increasing number of games, targeted at the major cognitive domains of memory (primarily), attention and executive functions. Since sessions will increase in length, researchers expect that more than 10 short games may eventually be played in each session. This will be an ABAA protocol for the experimental group, and a AABA protocol for the wait-list control group. Data will be sampled at baseline (A), during each rehabilitation session (B), mid-way through the study (at 2 months from baseline) and at the end of the study, at 4 months from baseline (A). At the end of every 4 weeks of BrightGo training, the participant and caregiver will each fill a custom subjective evaluation questionnaire. Before crossover to the experimental protocol, participants in the wait-list group will continue with their daily routine and prescribed medication (which will be logged). After crossing over, they will add the BrightGo intervention to their daily routine. Participants initially randomized to the experimental group will continue with daily routine and medication, and add the 5 sessions per week of experimental therapy. Once they cross over to the control arm after 8 weeks from start, they will continue with their daily routine and prescribed medication (which will again be logged) for another 8 weeks. All participants will receive a weekly call from the Clinical Coordinator so to report on any health concerns and system issues, as well as medication use. Caregivers will also be enrolled so they support the trials.

Conditions

• Alzheimer Disease
• Healthy Aging

Interventions

Type	Name	Description
DEVICE	BrightGo cognitive training	Training on the BrightGo experimental device in the home
DRUG	Standard of Care medication for early Alzheimer's Disease	Participant takes 10 mg of Aricept daily or wears an Exelon 9.5 mg patch and is stable on one of these medications that were prescribed for diagnostic of early Alzheimer's Disease

Timeline

• Start date: 2022-02-16
• Primary completion: 2022-12-31
• Completion: 2023-02-28
• First posted: 2021-02-01
• Last updated: 2022-05-02

Locations

2 sites across 1 country: United States