Alzheimer DiseaseNCT04055376
Daily Light and Sound Stimulation to Improve Brain Functions in Alzheimer's Disease
A study testing GENUS device (Active Settings) in people with Alzheimer Disease and Alzheimer Dementia, run by Massachusetts Institute of Technology at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Alzheimer Disease, Alzheimer Dementia
- What is being tested?
- GENUS device (Active Settings)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2019to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is between the ages of 50 - 100.
- Subject must have mild Alzheimer's disease with a Mini Mental State Exam (MMSE) score of 19 -26.
- Subject is willing to sign informed consent document.
- If subject is deemed to not have capacity to sign the informed consent, he/she will need a legally authorized representative to provide surrogate consent.
- Subjects whose primary residence is within 2 hours of Boston
- Able to complete the 1st month of at home stimulation at their primary residence; if subjects plan to spend more than 1 week away from their primary residence during the trial, their inclusion must be assessed by the research team.
Who cannot join
- Subjects who do not have healthcare.
- Subjects who are being treated with N-methyl-D-aspartate (NMDA) receptor antagonists (eg. Memantine).
- Subjects on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc.
- Subjects with history of seizure or epilepsy within the past 24 months.
- Subjects with clinically significant suicide risk and/or suicide attempt in the past 12 months.
- Subjects with behavioral problems such as aggression/agitation/impulsivity that might interfere with their ability to comply with protocol.
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- Active treatment with one or more anti-epileptic agent.
- Subjects who have had a stroke within the past 24 months.
- Subjects diagnosed with migraine headache.
- Active treatment with one or more psychiatric agent (e.g. antidepressants, antipsychotics, etc).
- Subjects who have an active implantable medical device including but not limited to implantable cardioverter defibrillator (ICD), deep brain stimulator (DBS), cardiac pacemaker, and/or sacral nerve stimulator.
- Subjects who have profound hearing or visual impairment.
- Subjects who have a life expectancy of less than 24 months.
- Subjects who are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139
About this study
Official title: Chronic Treatment of Alzheimer's Disease With Gamma Frequency Stimulation
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.
Read the detailed description
After screening for eligibility, subjects will be randomized into one of two study groups in a 1:1 ratio. Each subject will use a non-invasive light and sound device, called the GENUS device, at home for 1 hour per day for 6 or 9 months. The GENUS device, which is composed of a panel with light-emitting diode (LED) illumination and speakers for auditory stimulation, delivers light and sound at different frequencies.
Subjects in the first group will use the device with active settings, and subjects in the second group will use the device with sham settings. After 6 or 9 months of the daily usage of the device, all subjects will be given an option to continue the daily usage for additional 6 or 9 months. For these additional 6 or 9 months, the device will be set to active settings for all subjects who choose to remain in the study.
Over the first 6 or 9 months, cognitive, mental health and memory evaluations will be performed at baseline, after 1 month, after 3 months, and after 6 or 9 months of daily usage of the device. Blood draws as well as hearing and vision tests will be performed at baseline and after 6 or 9 months of daily usage of the device. Magnetic resonance imaging (MRI) and electroencephalogram (EEG) will also be performed at baseline, after 3 months, and after 6 or 9 months of daily usage of the device. For subjects who choose to continue the daily usage of the device for additional 6 or 9 months, MRI, EEG as well as cognitive, mental health and memory evaluations will be performed at the end of the 6 or 9 additional months of daily usage. One month after the completion of the daily usage, EEG as well as cognitive, mental health and memory evaluations will be performed (this will be 7 or 10 months after the start of the study for subjects who choose not to continue the daily usage of the device after the initial 6 or 9 months; this will be 13 or 19 months after the start of the study for subjects who choose to continue the daily usage of the device for additional 6 or 9 months after the initial 6 or 9 months).
Participants who complete the study protocol and finish the final study visit at Month 12 or 19 will be offered a long-term extension for a total of 36 months with yearly follow up evaluations.
- Conditions
- Alzheimer Disease, Alzheimer Dementia
- Being tested
- GENUS device (Active Settings), GENUS device (Sham Settings)
- Keywords
- Alzheimer Disease, Cognitive Impairment, Non-invasive Sensory Stimulation, Light and Sound Stimulation, Gamma
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GENUS device (Active Settings)Device
Also called Gamma frequency stimulation, Light and sound stimulation
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.
GENUS device (Sham Settings)Device
Also called Gamma frequency stimulation, Light and sound stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| Daily exposure to active stimulation | Experimental | Subjects in this arm will receive daily exposure to active stimulation Receives: Device: GENUS device (Active Settings) |
| Daily exposure to control stimulation | Sham comparator | Subjects in this arm will receive daily exposure to control stimulation Receives: Device: GENUS device (Sham Settings) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of at-home light and sound stimulation: amount of time of device usage per day
Feasibility of daily at-home light and sound stimulation will be assessed by keeping track of the amount of time the GENUS device is used per day. The device will automatically log the start and end times of the device usage. The log data will be collected and assessed at the interim analysis time points (Month 1, Month 3) and later time points (Month 6 or 9 and Month 12 or 18).
Measured: Over 6 or 9 months (or over 12 or 18 months for subjects who choose to continue the daily device usage for 6 or 9 additional months)
Safety of daily at-home light and sound stimulation: questionnaire
Safety of daily at-home light and sound stimulation will be assessed by using a daily questionnaire that asks for any adverse effects of the stimulation. The daily questionnaires will be collected and assessed at the interim analysis time point (Month 1) and later time points (Month 6 or 9 and Month 12 or 18).
Measured: Over 6 or 9 months (or over 12 or 18 months for subjects who choose to continue the daily device usage for 6 or 9 additional months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start14 Aug 2019
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly assigned to one of two study groups. Subjects in the first group will use the GENUS device with active settings for 6 or 9 months, and subjects in the second group will use the GENUS device with sham settings for 6 or 9 months. At the end of the 6 or 9 month period, all subjects will be given an option to continue the usage of the GENUS device for additional 6 or 9 months. For these additional 6 or 9 months, the device will be set to active settings for all subjects who choose to remain in the study. A 36-month compassionate use extension will be offered at the completion of all of the study visits.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Huei Tsai, PhD, Principal investigator, Massachusetts Institute of TechnologyEdward S Boyden, PhD, Principal investigator, Massachusetts Institute of TechnologyEmery Brown, MD, PhD, Principal investigator, Massachusetts Institute of TechnologyDiane Chan, MD, PhD, Principal investigator, Massachusetts Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055376
- Sponsor's protocol ID
- 1903763319
- Status last verified
- May 2026
- First submitted
- 5 Aug 2019
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Iaccarino HF, Singer AC, Martorell AJ, Rudenko A, Gao F, Gillingham TZ, Mathys H, Seo J, Kritskiy O, Abdurrob F, Adaikkan C, Canter RG, Rueda R, Brown EN, Boyden ES, Tsai LH. Gamma frequency entrainment attenuates amyloid load and modifies microglia. Nature. 2016 Dec 7;540(7632):230-235. doi: 10.1038/nature20587.
PubMed 27929004Martorell AJ, Paulson AL, Suk HJ, Abdurrob F, Drummond GT, Guan W, Young JZ, Kim DN, Kritskiy O, Barker SJ, Mangena V, Prince SM, Brown EN, Chung K, Boyden ES, Singer AC, Tsai LH. Multi-sensory Gamma Stimulation Ameliorates Alzheimer's-Associated Pathology and Improves Cognition. Cell. 2019 Apr 4;177(2):256-271.e22. doi: 10.1016/j.cell.2019.02.014. Epub 2019 Mar 14.
PubMed 30879788Adaikkan C, Middleton SJ, Marco A, Pao PC, Mathys H, Kim DN, Gao F, Young JZ, Suk HJ, Boyden ES, McHugh TJ, Tsai LH. Gamma Entrainment Binds Higher-Order Brain Regions and Offers Neuroprotection. Neuron. 2019 Jun 5;102(5):929-943.e8. doi: 10.1016/j.neuron.2019.04.011. Epub 2019 May 7.
PubMed 31076275Chan D, de Weck G, Jackson BL, Suk HJ, Milman NP, Kitchener E, Avalos VSF, Quay MJ, Aoki K, Ruiz E, Becker A, Zheng M, Philips R, Firenze R, Geigenmuller U, Hammerschlag B, Arnold S, Kivisakk P, Brickhouse M, Touroutoglou A, Brown EN, Boyden ES, Dickerson BC, Klerman EB, Tsai LH. Gamma sensory stimulation in mild Alzheimer's dementia: An open-label extension study. Alzheimers Dement. 2025 Oct;21(10):e70792. doi: 10.1002/alz.70792.
PubMed 41137616
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Treatment of Alzheimer's Disease With Gamma Frequency Stimulation
- ClinicalTrials.gov ID
- NCT04055376
- Acronym / sponsor ID
- 1903763319
- Conditions
- Alzheimer Disease, Alzheimer Dementia
- Keywords
- Alzheimer Disease, Cognitive Impairment, Non-invasive Sensory Stimulation, Light and Sound Stimulation, Gamma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Massachusetts Institute of TechnologyUniversity, hospital or other
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After screening for eligibility, subjects will be randomized into one of two study groups in a 1:1 ratio. Each subject will use a non-invasive light and sound device, called the GENUS device, at home for 1 hour per day for 6 or 9 months. The GENUS device, which is composed of a panel with light-emitting diode (LED) illumination and speakers for auditory stimulation, delivers light and sound at different frequencies.
Subjects in the first group will use the device with active settings, and subjects in the second group will use the device with sham settings. After 6 or 9 months of the daily usage of the device, all subjects will be given an option to continue the daily usage for additional 6 or 9 months. For these additional 6 or 9 months, the device will be set to active settings for all subjects who choose to remain in the study.
Over the first 6 or 9 months, cognitive, mental health and memory evaluations will be performed at baseline, after 1 month, after 3 months, and after 6 or 9 months of daily usage of the device. Blood draws as well as hearing and vision tests will be performed at baseline and after 6 or 9 months of daily usage of the device. Magnetic resonance imaging (MRI) and electroencephalogram (EEG) will also be performed at baseline, after 3 months, and after 6 or 9 months of daily usage of the device. For subjects who choose to continue the daily usage of the device for additional 6 or 9 months, MRI, EEG as well as cognitive, mental health and memory evaluations will be performed at the end of the 6 or 9 additional months of daily usage. One month after the completion of the daily usage, EEG as well as cognitive, mental health and memory evaluations will be performed (this will be 7 or 10 months after the start of the study for subjects who choose not to continue the daily usage of the device after the initial 6 or 9 months; this will be 13 or 19 months after the start of the study for subjects who choose to continue the daily usage of the device for additional 6 or 9 months after the initial 6 or 9 months).
Participants who complete the study protocol and finish the final study visit at Month 12 or 19 will be offered a long-term extension for a total of 36 months with yearly follow up evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to one of two study groups. Subjects in the first group will use the GENUS device with active settings for 6 or 9 months, and subjects in the second group will use the GENUS device with sham settings for 6 or 9 months. At the end of the 6 or 9 month period, all subjects will be given an option to continue the usage of the GENUS device for additional 6 or 9 months. For these additional 6 or 9 months, the device will be set to active settings for all subjects who choose to remain in the study. A 36-month compassionate use extension will be offered at the completion of all of the study visits.
| Arm | Type | Receives |
|---|---|---|
| Daily exposure to active stimulation | Experimental | Device: GENUS device (Active Settings)Subjects in this arm will receive daily exposure to active stimulation |
| Daily exposure to control stimulation | Sham comparator | Device: GENUS device (Sham Settings)Subjects in this arm will receive daily exposure to control stimulation |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is between the ages of 50 - 100.
- Subject must have mild Alzheimer's disease with a Mini Mental State Exam (MMSE) score of 19 -26.
- Subject is willing to sign informed consent document.
- If subject is deemed to not have capacity to sign the informed consent, he/she will need a legally authorized representative to provide surrogate consent.
- Subjects whose primary residence is within 2 hours of Boston
Key exclusion criteria (14 listed)
- Subjects who do not have healthcare.
- Subjects who are being treated with N-methyl-D-aspartate (NMDA) receptor antagonists (eg. Memantine).
- Subjects on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc.
- Subjects with history of seizure or epilepsy within the past 24 months.
- Subjects with clinically significant suicide risk and/or suicide attempt in the past 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GENUS device (Active Settings)Also: Gamma frequency stimulation, Light and sound stimulationParticipants 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 | Daily exposure to active stimulation |
| GENUS device (Sham Settings)Also: Gamma frequency stimulation, Light and sound stimulationParticipants 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. | Device | Daily exposure to control stimulation |
Primary outcome
Feasibility of at-home light and sound stimulation: amount of time of device usage per day
Time frame: Over 6 or 9 months (or over 12 or 18 months for subjects who choose to continue the daily device usage for 6 or 9 additional months)
Feasibility of daily at-home light and sound stimulation will be assessed by keeping track of the amount of time the GENUS device is used per day. The device will automatically log the start and end times of the device usage. The log data will be collected and assessed at the interim analysis time points (Month 1, Month 3) and later time points (Month 6 or 9 and Month 12 or 18).
Safety of daily at-home light and sound stimulation: questionnaire
Time frame: Over 6 or 9 months (or over 12 or 18 months for subjects who choose to continue the daily device usage for 6 or 9 additional months)
Safety of daily at-home light and sound stimulation will be assessed by using a daily questionnaire that asks for any adverse effects of the stimulation. The daily questionnaires will be collected and assessed at the interim analysis time point (Month 1) and later time points (Month 6 or 9 and Month 12 or 18).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 27929004Iaccarino HF, Singer AC, Martorell AJ, Rudenko A, Gao F, Gillingham TZ, Mathys H, Seo J, Kritskiy O, Abdurrob F, Adaikkan C, Canter RG, Rueda R, Brown EN, Boyden ES, Tsai LH. Gamma frequency entrainment attenuates amyloid load and modifies microglia. Nature. 2016 Dec 7;540(7632):230-235. doi: 10.1038/nature20587.
- Background: PubMed 30879788Martorell AJ, Paulson AL, Suk HJ, Abdurrob F, Drummond GT, Guan W, Young JZ, Kim DN, Kritskiy O, Barker SJ, Mangena V, Prince SM, Brown EN, Chung K, Boyden ES, Singer AC, Tsai LH. Multi-sensory Gamma Stimulation Ameliorates Alzheimer's-Associated Pathology and Improves Cognition. Cell. 2019 Apr 4;177(2):256-271.e22. doi: 10.1016/j.cell.2019.02.014. Epub 2019 Mar 14.
- Background: PubMed 31076275Adaikkan C, Middleton SJ, Marco A, Pao PC, Mathys H, Kim DN, Gao F, Young JZ, Suk HJ, Boyden ES, McHugh TJ, Tsai LH. Gamma Entrainment Binds Higher-Order Brain Regions and Offers Neuroprotection. Neuron. 2019 Jun 5;102(5):929-943.e8. doi: 10.1016/j.neuron.2019.04.011. Epub 2019 May 7.
- Derived from this study: PubMed 41137616Chan D, de Weck G, Jackson BL, Suk HJ, Milman NP, Kitchener E, Avalos VSF, Quay MJ, Aoki K, Ruiz E, Becker A, Zheng M, Philips R, Firenze R, Geigenmuller U, Hammerschlag B, Arnold S, Kivisakk P, Brickhouse M, Touroutoglou A, Brown EN, Boyden ES, Dickerson BC, Klerman EB, Tsai LH. Gamma sensory stimulation in mild Alzheimer's dementia: An open-label extension study. Alzheimers Dement. 2025 Oct;21(10):e70792. doi: 10.1002/alz.70792.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Huei Tsai, PhD principal investigator
Massachusetts Institute of Technology
Edward S Boyden, PhD principal investigator
Massachusetts Institute of Technology
Emery Brown, MD, PhD principal investigator
Massachusetts Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GENUS device (Active Settings) in people with Alzheimer Disease and Alzheimer Dementia, run by Massachusetts Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of at-home light and sound stimulation: amount of time of device usage per day (time frame: Over 6 or 9 months (or over 12 or 18 months for subjects who choose to continue the daily device usage for 6 or 9 additional months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04055376, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.