A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer’s Disease Dementia (The DAYBREAK Study)
The DAYBREAK study is a clinical research study in mild Alzheimer’s disease. We are looking for people who would like to participate. The study will examine an oral investigational drug called LY3314814. The drug may have some effect on the brain changes associated with Alzheimer’s disease. The study is designed to find out whether this investigational drug (or “study drug”) can slow down the decline in memory and mental functioning. Investigational means that the drug is still being evaluated in clinical studies, and has not yet been approved for use by doctors in their everyday practices. The DAYBREAK study will include approximately 1900 participants from around the globe.
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You may be eligible for the study if you:
• are between 55 and 85 years old
• Have experienced a gradual loss of memory over the last 6 months (the study team will assess whether this is due to Alzheimer’s disease)
OR Have been diagnosed with mild Alzheimer’s disease
• Have a close friend, relative or partner who would be willing to be your study partner throughout the study
What happens during the study?
A telephone screening will be conducted to determine if you are eligible to come in for an in-person screening visit. This screening visit will determine if you are eligible to participate in the study. As part of the screening procedures, you will have an MRI and a PET scan using Amyvid, an FDA-approved compound to determine the presence or absence of amyloid deposits in the brain.
The study will last for around three years – 8 weeks to see if you qualify, plus 3 years of treatment, then 4 weeks of follow-up.
The study drug is a tablet, to be taken once a day. The tablet will contain either a lower dose of the study drug, a higher dose of the study drug, or a placebo, depending on which group you are assigned to. A placebo tablet is one that contains no active ingredients.
You will be assigned at random to one of the study groups. Neither you nor the study doctor will know which group you’ve been assigned to. There is a 2 in 3 chance that you will receive the study drug. If it is necessary to find out which group you’ve been assigned to, the study doctor can do so quickly.
You will need a study partner. This person needs to be someone who you are in regular contact with, who will go with you to study appointments, and who can help the study team to notice any changes in your mental functioning
Where is this study taking place?
Boston University Medical Center
Meet the team
Robert A. Stern, PhD – Principal Investigator
Wendy Qiu, MD, PhD – Study Physician
Jesse Mez, MD – Study Physician
Jane Mwicigi, MPH – Study Coordinator
Dawn Jacobs, MPH – Clinical Research Coordinator
Please call 617-414-1077 or email JoinADC@bu.edu for more information about participating.