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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorAlzheimer's Light LLC

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Combination of 40Hz light and cognitive therapy (ALZLIFE)

    Device

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

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Participants who adhere to the protocol1 intervention
Group B: Participants who do not adhere to the protocol1 intervention

Trial outcomes

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.

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

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.

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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