Summary:
Key Trial Details
• For the Sunrise Alzheimer’s Disease study, participants have a 50% chance of receiving
the study medication and a 50% chance of receiving a placebo. Neither the participant nor
the investigator will know whether the participant is on the active medication or a placebo.
• The placebo is a medication that doesn’t have any active medical ingredients. Neither the
study staff nor you will know which group you are in. However, in case of an emergency the
doctor can quickly find out.
• The investigational medication or placebo will be in the form of an oral medication, taken
once daily at bedtime over a 6-week treatment period.
Eligibility Requirements
An eligible participant for this study must:
• Be 55-85 years old
• Have been diagnosed with Alzheimer’s Disease by a doctor
• Have an available study partner who can be present for all study visits
• A study partner is someone who can join the patient at all study visits and remote visits,
can assist the patient with taking the investigational medication each night, and can
help complete daily medication logs.
• Have developed an increased frequency of symptoms of agitation after Alzheimer’s
Disease diagnosis. Agitation can include one or more of following behaviors:
• Resisting help from others (i.e., with daily activities), being uncooperative or stubborn
(insistence on having their own way), screaming or shouting, cursing angrily, hitting
self or others, kicking, pushing, throwing objects, or slamming doors
Additional eligibility criteria will be assessed by the study doctor or staff during the screening
process prior to being enrolled in the study and receiving any investigational medication. Not
all individuals will qualify to participate.
Qualified Participants May Receive:
Study Related Care
Investigational Medicine
Stipend for Caregiver and Patient for time and travel