Alzheimer's Disease Treatment With Combination of 40Hz Light and Cognitive Therapy (AlzLife)
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ClinicalTrials.gov Identifier: NCT03657745 |
Recruitment Status :
Recruiting
First Posted : September 5, 2018
Last Update Posted : February 1, 2023
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Condition or disease | Intervention/treatment |
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Alzheimer Disease Mild Cognitive Impairment Dementia Cognition Disorders in Old Age Cognitive Decline Cognitive Deterioration | Device: Combination of 40Hz light and cognitive therapy (ALZLIFE) |
New research suggests that exposure to a light flickering at 40Hz may promote gamma brain wave activity through the photic entrainment phenomenon. These waves have the potential to activate critical cleaning cells in the brain that could eliminate beta amyloid plaques. The most recent research on light therapy for Alzheimer's disease appeared in the journal Nature in 2017, entitled "How flashing lights and pink noise might banish Alzheimer's, improve memory and more" (the full article can be freely accessed at: https://www.nature.com/articles/d41586-018-02391-6) and in 2016, entitled "Gamma frequency entrainment attenuates amyloid load and modifies microglia" (the article abstract can be accessed at: https://www.nature.com/articles/nature20587). Researchers from MIT found that shining a strobe light into the eyes of mice with a rodent version of Alzheimer's disease encouraged protective cells to phagocytize the harmful proteins that accumulate in the brain. The perfect rate of flashes was determined to be 40 per second. Exposure to the flashing light for an hour (light therapy) led to a noticeable reduction in beta amyloid levels the next day in regions of the neocortex and hippocampus. When done every day for a week, beta amyloid levels were greatly reduced.
In addition, there is a significant body of evidence that computerized brain training (cognitive therapy) improves the memory of patients with Alzheimer's and dementia, which could help avert some symptoms of cognitive decline.
The synergistic combination of light and cognitive therapy utilized in AlzLife has the potential to improve the brain's function better than either of these therapies alone. This project will test the ability of a novel iPad App ("ALZLIFE") that delivers light therapy at 40 Hz combined with cognitive therapy to improve cognition, function, and quality of life in Alzheimer's disease.
Study Type : | Observational |
Estimated Enrollment : | 2000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | An Observational Trial of Alzheimer's Disease Treatment With Combination of 40Hz Light and Cognitive Therapy |
Actual Study Start Date : | January 1, 2018 |
Estimated Primary Completion Date : | December 31, 2025 |
Estimated Study Completion Date : | December 31, 2025 |

Group/Cohort | Intervention/treatment |
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Participants who adhere to the protocol
All participants are encouraged to exercise with AlzLife daily for 30 minutes a day. The actual duration is to be measured through participant's interactions with ALZLIFE. Participants adhere to the protocol if they exercise with AlzLife the minimum of 1hour/week.
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Device: Combination of 40Hz light and cognitive therapy (ALZLIFE)
Combination of 40Hz light and cognitive therapy delivered by iPad application ALZLIFE |
Participants who do not adhere to the protocol
All participants are encouraged to exercise with AlzLife daily for 30 minutes a day. The actual duration is to be measured through participant's interactions with ALZLIFE. Participants do not adhere to the protocol if they exercise with AlzLife less than 1hour/week.
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Device: Combination of 40Hz light and cognitive therapy (ALZLIFE)
Combination of 40Hz light and cognitive therapy delivered by iPad application ALZLIFE |
- In-app cognitive test [ Time Frame: through study completion, an average of 1 year ]
The cognitive therapy delivered by ALZLIFE consist of cognitive games: Sudoku, Tic-Tac-Toe, Analog clock comparison, etc. The changes in performance score in these cognitive games are used to calculate the participant's Cognitive Index.
Cognitive Index maximum score = 100. The lower score indicates worse performance.
- Alzheimer's Disease Cooperative Study-activities of daily living (ADCS-ADL) [ Time Frame: through study completion, an average of 1 year ]The ADCS-ADL assesses the competence of patients with Alzheimer's Disease (AD) in basic and instrumental activities of daily living (ADLs). ADCS-ADL is assessed by an in-app evaluation completed by a caregiver every month. All responses relate to the 4 weeks prior to the time of rating. The six basic ADL items each take an ADL (e.g., eating) and provide descriptions of level of competence, with the rater selecting the most appropriate option (e.g., ate without physical help and used a knife; used a fork or spoon but not a knife; used fingers to eat; was usually fed by someone else). ADCS-ADL maximum score = 30. The lower score indicates worse outcome.

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Alzheimer's disease
- Cognitive Impairment
Exclusion Criteria:
- any previously noted epileptic seizures, including febrile seizures.
- any significant disease of the eye, such as macular degeneration. Since the 40Hz light therapy is delivered via eye stimulation, healthy eyes are required.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657745
Contact: Andrey Vyshedskiy, Ph.D. | (617) 433-7724 | vysha@bu.edu |
United States, Florida | |
Andrey Vyshedskiy | Recruiting |
Miami, Florida, United States, 33156 | |
Contact: Andrey Vyshedskiy 617-433-8577 vysha@bu.edu |
Publications:
Responsible Party: | Alzheimer's Light LLC |
ClinicalTrials.gov Identifier: | NCT03657745 |
Other Study ID Numbers: |
AlzLife001 |
First Posted: | September 5, 2018 Key Record Dates |
Last Update Posted: | February 1, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Alzheimer Disease Alzheimer's Dementia |
Alzheimer Disease Dementia Cognitive Dysfunction Cognition Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |