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NCT Number: NCT03657745

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Andrey Vyshedskiy

Miami, Florida, 33156, United States

Location status: Recruiting

Location contact

Andrey Vyshedskiy

CONTACT

[email protected]

617-433-8577

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combination of 40Hz light and cognitive therapy (ALZLIFE)

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrey Vyshedskiy, Ph.D.

CONTACT

[email protected]

(617) 433-7724

Sponsors and collaborators

Lead sponsor

Alzheimer's Light LLC

Industry

Registry information

Official study title

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

Acronym: AlzLife

Important dates

Study start
2018
Primary completion
2029
Study completion
2029
First posted
Sep 5, 2018
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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