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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03657745
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
Alzheimer's Light LLC

Brief Summary:
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.

Condition or disease Intervention/treatment
Alzheimer Disease Mild Cognitive Impairment Dementia Cognition Disorders in Old Age Cognitive Decline Cognitive Deterioration Device: Combination of 40Hz light and cognitive therapy (ALZLIFE)

Detailed Description:

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.

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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, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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.
Device: Combination of 40Hz light and cognitive therapy (ALZLIFE)
Combination of 40Hz light and cognitive therapy delivered by iPad application ALZLIFE




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Study Population
Alzheimer's disease and Cognitive Impairment
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Andrey Vyshedskiy, Ph.D. (617) 433-7724 vysha@bu.edu

Locations
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United States, Florida
Andrey Vyshedskiy Recruiting
Miami, Florida, United States, 33156
Contact: Andrey Vyshedskiy    617-433-8577    vysha@bu.edu   
Sponsors and Collaborators
Alzheimer's Light LLC

Additional Information:
Publications:
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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: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alzheimer's Light LLC:
Alzheimer Disease
Alzheimer's
Dementia
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Cognitive Dysfunction
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders