The DAYBREAK - ALZ Study

Eligibility Criteria

To join the study you must:

  • Be between 55 and 85 years old
  • Have a close family friend, relative or partner who would be willing to be your study partner throughout the study
  • 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 

What does joining involve?

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 and 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 the study appointments, and who can help the study team to notice any changed in your mental functioning.

If you join the study, you and your study partner will be asked to attend around 29 appointments. During these appointments, we will assess your health, thinking and memory with some standard medical tests and questionnaires. We will also ask you about any side effects you may experience. These appointments will be every 3 weeks for the first few visits and then every 7 weeks until the end of the study.

What else should you know about the study?

If you are already receiving treatment for Alzheimer's disease, it may be possible to continue taking them. The study team will let you know.

There is no guarantee that the study drug will improve your symptoms. Your safety is our first priority. Throughout the study, your health will be carefully monitored at all appointments. The study drug will be stopped if you or the study doctor have any concerns, or if you change your mind about being in the study.

The study drug and all study-related care will be provided free of charge. You may be compensated for time and travel.

 

For more information please contact Nicole Gullotti at: ngullotti@bu.edu