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

Alzheimer Disease Clinical Trial

— AlzLife  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03657745
• Other study ID #: AlzLife001
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2023
• Source: Alzheimer's Light LLC
• Contact: Andrey Vyshedskiy, Ph.D.
• Phone: (617) 433-7724
• Email: vysha[@]bu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Combination of 40Hz light and cognitive therapy (ALZLIFE)
Combination of 40Hz light and cognitive therapy delivered by iPad application ALZLIFE

Locations

Country	Name	City	State
United States	Andrey Vyshedskiy	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alzheimer's Light LLC

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Erratum In: Nature. 2018 Oct;562(7725):E1. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-app cognitive test	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.	through study completion, an average of 1 year
Secondary	Alzheimer's Disease Cooperative Study-activities of daily living (ADCS-ADL)	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.	through study completion, an average of 1 year

External Links

•   ALZLIFE application in the App Store
•   ALZLIFE website