Alzheimer's Disease Treatment With Combination of 40Hz Light and Cognitive Therapy

NCT ID: NCT03657745

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2029-12-31

Brief Summary

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Electrical activity in the brain known as "gamma" brainwaves help connect and process information throughout the brain. These gamma waves are diminished in Alzheimer's disease. New research in Alzheimer's disease mouse models shows that exposure to light flickering at the rate of 40 flashes per second or 40Hz increased gamma brainwaves and led to clearing of beta amyloid plaques in the brain, a key abnormality in Alzheimer's disease. This project will test the ability of a novel iPad App (AlzLife https://www.alz.life/) that delivers light therapy at 40 Hz combined with cognitive therapy to improve cognition, function, and quality of life in Alzheimer's disease.

Detailed Description

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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.

Conditions

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Alzheimer Disease Mild Cognitive Impairment Dementia Cognition Disorders in Old Age Cognitive Decline Cognitive Deterioration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Combination of 40Hz light and cognitive therapy (ALZLIFE)

Intervention Type DEVICE

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.

Combination of 40Hz light and cognitive therapy (ALZLIFE)

Intervention Type DEVICE

Combination of 40Hz light and cognitive therapy delivered by iPad application ALZLIFE

Interventions

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Combination of 40Hz light and cognitive therapy (ALZLIFE)

Combination of 40Hz light and cognitive therapy delivered by iPad application ALZLIFE

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alzheimer's Light LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Andrey Vyshedskiy

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andrey Vyshedskiy, Ph.D.

Role: CONTACT

(617) 433-7724

Facility Contacts

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Andrey Vyshedskiy

Role: primary

617-433-8577

References

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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.

Reference Type BACKGROUND
PMID: 27929004 (View on PubMed)

Thomson H. How flashing lights and pink noise might banish Alzheimer's, improve memory and more. Nature. 2018 Mar 1;555(7694):20-22. doi: 10.1038/d41586-018-02391-6. No abstract available.

Reference Type BACKGROUND
PMID: 29493598 (View on PubMed)

Martorell 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.

Reference Type BACKGROUND
PMID: 30879788 (View on PubMed)

Related Links

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Other Identifiers

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AlzLife001

Identifier Type: -

Identifier Source: org_study_id

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