About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Alzheimer's disease
Cognitive Impairment
Disqualifiers
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.
Trial population
Alzheimer's disease and Cognitive Impairment
Trial design
Cohort
Prospective
Treatments tested in this trial
Combination of 40Hz light and cognitive therapy (ALZLIFE)
DeviceCombination of 40Hz light and cognitive therapy delivered by iPad application ALZLIFE
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Sponsors and contacts
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