Daily Light and Sound Stimulation to Improve Brain Functions in Alzheimer's Disease

Summary

In this trial, the safety and effect of daily exposure to light and sound stimulation on people with mild Alzheimer's Disease (AD) will be studied.

COVID-19 Amendment: Due to the ongoing suspension of all in-person humans subject research across MIT in response to the COVID-19 pandemic, all enrolled participants who have not completed their 6-month visit will have their visit postponed to 9 months with a follow up at 18 months. Subjects who have completed their 6-month visit will still be instructed to continue and return at Month 12 for an evaluation.

OPTIONAL: If the subject would like to come in for an evaluation between Month 9 and 18, we will invite participants to come on Month 12 to complete cognitive testing and EEG.

Conditions

• Alzheimer Disease
• Alzheimer Dementia

Interventions

DEVICE

GENUS device (Active Settings)

Participants in the experimental group will use the GENUS device configured to active settings for 60 minutes daily over 6 or 9 months. After 6 or 9 months, each participant will be given an option to continue the daily usage of the GENUS device configured to active settings for additional 6 or 9 months. Note: Due to the COVID-19 pandemic, participants who have not yet reached the 6-month mark will have their 6 month visit postponed to 9 months.

DEVICE

GENUS device (Sham Settings)

Participants in the control group will use the GENUS device configured to sham settings for 60 minutes daily over 6 or 9 months. After 6 or 9 months, each participant will be given an option to continue the daily usage of the GENUS device configured to active settings for additional 6 or 9 months. Note: Due to the COVID-19 pandemic, participants who have not yet reached the 6-month mark will have their 6 month visit postponed to 9 months.

Sponsors & Collaborators

• Massachusetts Institute of Technology

  lead OTHER

Principal Investigators

• Li-Huei Tsai, PhD · Massachusetts Institute of Technology

• Edward S Boyden, PhD · Massachusetts Institute of Technology

• Emery Brown, MD, PhD · Massachusetts Institute of Technology

• Diane Chan, MD, PhD · Massachusetts Institute of Technology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-14

Primary Completion

2025-04-30

Completion

2025-04-30

FDA Device

Yes

Countries

• United States

Study Locations