Efficacy and Safety of Ramelteon in Subjects With Mild to Moderate Alzheimer's Disease

Exclusion Criteria

• •Non-ambulatory, wheel chair bound or confined to bed and is without a consistent caregiver who is present during the night who could function as the primary caregiver.
• •Caregiver is deemed by the investigator to be unreliable to supervise the wearing of the actigraphy, to complete the sleep log, to administer medication at the proper time, to bring the subject to the scheduled visits or to answer questions regarding the subject's condition or medication use.
• •Lacks a mobile upper extremity to which to attach an actigraphy.
• •Currently participating or has participated in another clinical study within the past 30 days.
• •Demonstrates an unwillingness to abstain from caffeine after 2:00 PM for the duration of the clinical trial participation.
• •Demonstrates an unwillingness to comply with the maximum limit of two alcoholic drinks per day and only one alcoholic drink after 6:00 PM for the duration of the protocol.
• •Uses tobacco products or any other products during nightly awakenings that may interfere with the sleep wake cycle.
• •History of drug abuse or tests positive for the presence of illicit drugs.
• •Donated more than 400 mL of blood within the 90 days preceding the beginning of the study.
• •Diastolic blood pressure greater than 95 mm Hg or a systolic pressure of greater than 160 mm Hg.
• •Body mass index of greater than 36.
• •Alanine transaminase level of greater than two times the upper limit of normal, active liver disease, jaundice or any clinically significant abnormal laboratory findings as determined by the investigator.
• •History of a hypersensitivity or allergies to Ramelteon or melatonin.
• •History of contraindications as noted in the Ramelteon label
• •History of significant stroke or vascular dementia.
• •History of severe renal dysfunction or disease.
• •History of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study drug. (This criterion does not include those subjects with basal cell or Stage 1 squamous cell carcinoma of the skin.)
• •Any clinically significant movement disorder including but not limited to: akinesia, periodic limb movement disorder, restless leg syndrome, epilepsy, uncontrolled Parkinson's disease, or severe benign prostatic hyperplasia, cardiac asthma, chronic obstructive pulmonary disease.
• •Rapid eye movement behavior disorder or sleep apnea.
• •Any pain syndrome affecting sleep.
• •Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
• •* Fluvoxamine
• •* Melatonin
• •* Rifampicin