Alzheimer's Disease Treatment With Combination of 40Hz Light and Cognitive Therapy
AlzLife
An Observational Trial of Alzheimer's Disease Treatment With Combination of 40Hz Light and Cognitive Therapy
1 other identifier
observational
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 16, 2018
CompletedFirst Posted
Study publicly available on registry
September 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
August 1, 2024
July 1, 2024
12 years
August 16, 2018
July 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Alzheimer's Disease Cooperative Study-activities of daily living (ADCS-ADL)
through study completion, an average of 1 year
Study Arms (2)
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.
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.
Interventions
Combination of 40Hz light and cognitive therapy delivered by iPad application ALZLIFE
Eligibility Criteria
Alzheimer's disease and Cognitive Impairment
You may qualify if:
- Alzheimer's disease
- Cognitive Impairment
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Andrey Vyshedskiy
Miami, Florida, 33156, United States
Related 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.
PMID: 27929004BACKGROUNDThomson 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.
PMID: 29493598BACKGROUNDMartorell 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.
PMID: 30879788BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2018
First Posted
September 5, 2018
Study Start
January 1, 2018
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
August 1, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share