You must be diagnosed with mild dementia due to Alzheimer’s disease and have experienced a cognitive decline over at least 6 months
You must not have an alternative cause for dementia other than Alzheimer’s disease
You must have a caregiver who is willing to attend all study visits
About the Study:
This study aims to investigate the safety and effectiveness of investigational drug (Piromelatine) for people diagnosed with mild Alzheimer’s. The trial consists of a 28 week study to compare Piromelatine to placebo.
Qualified participants will be seen by a doctor and receive all study-related exams, care and medications at no cost. Compensation for travel is available.
The purpose of this research study is to determine an effective dose of piromelatine, based on results of safety and efficacy on participants with mild dementia due to Alzheimer’s disease as compared to placebo.
What is Involved:
If you are determined to be eligible, and agree to participate, you will be randomly assigned (like the flip of a coin) to receive one of three doses (5 mg, 20 mg, or 50 mg) of the investigational drug-piromelatine, or placebo. Study participants have a greater chance of receiving the investigational drug than placebo.
The study will take place over 28 weeks. Participants will have 5-6 visits to the study clinic and weekly telephone calls in between each visit. Each study visit will last approximately 2-3 hours. For each visit, participants will need to come with partner/caregiver who knows them well and can accompany them to clinic visits.
Throughout the study, doctors and the study staff will evaluate the health and progress of all study participants through various tests and assessments during the clinic visits and weekly phone calls. Some of these include, but are not limited to: • Review of medical history (including past and current health, medications, or treatments) • Physical exams • Vital signs measurements • Reviews of current medications • Blood and urine sample collections • Tests that measure mental skills and memory
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