AlzLife Clinical Trial Consent Form

Title of the trial: Alzheimer’s Disease Treatment With Combination of 40Hz Light, Sound and Cognitive Therapy (AlzLife)

Principal investigator:  Andrey Vyshedskiy, PhD

Phone number:  (617) 433-8577

Clinicaltrials.gov identifier: NCT03657745

 

What is the purpose of this trial?

The main goal of this trial is to activate the brain’s natural protective mechanisms that can remove the harmful protein groupings. The combination of 40Hz light, sound and cognitive therapy used in AlzLife has the potential to slow down or reverse the cognitive decline associated with Alzheimer’s disease.

Who can enroll into the study?

You can enroll, if you do not have any history epileptic seizures, including febrile seizures and do not have any significant disease of the eye, such as macular degeneration. Since the 40Hz light therapy is delivered via eye stimulation, healthy eyes are required.

What happens in the trial?

You are encouraged to purchase iPad Pro 2017 or newer (or another device with the screen refresh rate of 80Hz or greater, such as Samsung S20) and to exercise with AlzLife app at home for one hour a day. On the device you will play any cognitive games of your choosing, such as Sudoku, Tic-Tac-Toe, and various memory games. You will start the cognitive games at an easy level and progressively advance to a higher difficulty level that is still challenging but not uncomfortable. You may or may not notice the flickering of the background due to light stimulation. Most people will get used to the flicker after short period of time.

What are the possible benefits and drawbacks of participation?

The therapy can potentially slow down or reverse the cognitive decline associated with Alzheimer’s disease. There is minimal risk of experiencing an epileptic seizure in a very small fraction of participants. Please report to your physician if you ever had seizures in the past or febrile seizure as a child. If you feel dizzy or uncomfortable at any time using AlzLife, please stop using the app and report to your physician.

Do I have to take part?

You DO NOT have to consent. It is your free decision whether or not to participate.

What if I enroll in the trial, but change my mind later?

Participation in the trial is completely voluntary. Even after you have agreed to participate, you can withdraw your consent at any time. The information collected up until the time of your withdrawal may still be used. This is important for the integrity of the trial. You can withdraw your consent at any time.

Who will have access to mine or my child’s study and/or medical information?

During registration, we collect the year of birth. To avoid privacy concerns, we do not collect the exact date of birth or your name. Analyzed cumulative data across all participants may be published in research journal papers or conference proceedings. All published data is completely anonymous such that no individual may be directly or indirectly identified.

 

Who do I contact if I have questions about the study?

– Andrey Vyshedskiy, Ph.D., email: [email protected] or phone: (617) 433-8577.