Summary
The purpose of this research study is to determine an effective dose of Piromelatine, based on results of safety and efficacy on patients with mild dementia due to Alzheimer’s disease. The potential sleep enhancing capacities of Piromelatine may also be important to the study. Recent clinical and biochemical evidence has identified an interesting link between sleep, cognitive dysfunction and Alzheimer’s disease.
The study will take place over 28 weeks. You will have 5 visits to the study clinic and weekly telephone calls in between each visit. Each study visit will last approximately 2-3 hours. Additional unscheduled visits may be needed if the study doctor believes it is in your best interest.
Total # of Subjects Needed:
This study will involve about 575 subjects at about 90 different centers in the United States.
Study Details
Patients with a documented history of mild dementia due to AD for at least 6 months and who have been on stable doses of AD medication for at least 3 months, will be screened for eligibility. Caregiver commitment for the study is also necessary (defined as someone who is not expected to change during the course of the study, stays overnight with the patient at least 3 nights a week at the patient’s home, and is responsible for the overall care of the patient at home).
Patients will undergo neuropsychiatric assessments, psychometric testing and general medical assessments (including medical history, pre-existing conditions, physical examination, vital signs, and ECG). A computed tomography (CT) or magnetic resonance imaging (MRI) scan will be obtained to rule out clinically significant comorbid pathologies for patients who did not have this scan in the last 12 months before Screening (CT or MRI scan is performed free of charge for the patient).
Piromelatine will be administered orally, once daily, after a meal, before habitual bedtime, preferably between 2100h and 2300h. Patients will be required to spend at least 2 hours a day exposed to daylight.
Apply for study
If you would like to learn more about the different study opportunities you may call 1-800-530-0998 or for local callers please call 801-356-5555. To apply for this study you may also fill out the online application here: Alzheimer’s Disease (Mild) - Currently Taking AD Medication.