Efficacy and Safety of Ramelteon in Subjects With Mild to Moderate Alzheimer's Disease
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of 8 Week Treatment of Rozerem 8 mg (QHS) in Sleep Disturbed, Mild to Moderately Severe Alzheimer's Disease Subjects|
- Mean Nighttime Total Sleep Time as determined by actigraphy. [ Time Frame: Week 1 ]
- Change from Baseline in Nighttime Total Sleep Time [ Time Frame: Weeks 2, 4, 6, and 8 or Final Visit ]
- Change from Baseline in Nighttime Wake After Sleep Onset per Actigraphy [ Time Frame: Weeks 2, 4, 6, and 8 or Final Visit ]
- Change from Baseline in Nighttime Number Of Awakenings per Actigraphy [ Time Frame: Weeks 2, 4, 6, and 8 or Final Visit ]
- Change from Baseline in Daytime Total Sleep Time [ Time Frame: Weeks 2, 4, 6, and 8 or Final Visit ]
- Change from Baseline in the ratio of Daytime Total Sleep Time to Nighttime Total Sleep Time. [ Time Frame: Weeks 2, 4, 6, and 8 or Final Visit ]
- Change from Baseline in Sleep Efficiency. [ Time Frame: Weeks 2, 4, 6, and 8 or Final Visit ]
- Percentage of subjects who experience Increase in Nighttime Total Sleep Time of 30 minutes. [ Time Frame: Weeks 2, 4, 6, and 8 or Final Visit ]
- Number of Daytime Naps. [ Time Frame: Weeks 2, 4, 6, and 8 or Final Visit ]
|Actual Study Start Date:||March 21, 2006|
|Study Completion Date:||August 20, 2007|
|Primary Completion Date:||August 1, 2007 (Final data collection date for primary outcome measure)|
|Experimental: Ramelteon 8 mg QD||
Ramelteon 8mg, tablets, orally, once nightly for up to 8 weeks.
|Placebo Comparator: Placebo||
Ramelteon placebo matching tablets, orally, once nightly for up to 8 weeks.
Epidemiological data for 2005 show that an estimated 4.2 million people in the US suffer from Alzheimer's disease, often necessitating caregiver assistance, which can in many cases progress to institutionalization. Subjects with Alzheimer's disease dementia frequently experience disturbed sleep patterns characterized by insufficient nocturnal sleep and excessive daytime napping, which has been associated with both cognitive and behavioral pathology such as impaired daytime functioning, agitation, and nocturnal wandering.
Although the causality of sleep disturbances in Alzheimer's disease remains unclear; some research suggests that the fragmented sleep and associated behavioral disturbances could be related to the degeneration of the serotonergic and noradrenergic innervation of suprachiasmatic nucleus andsubsequent disruption in melatonin secretion patterns. Additionally, research suggests that melatonin levels are decreased in patients with Alzheimer's disease
In the United States, ramelteon is marketed for the treatment of insomnia characterized by difficulty with sleep onset and is under global development for the treatment of transient, chronic insomnia and circadian rhythm sleep disorders. It is believed that ramelteon works by binding melatonin to MT1/MT2 receptors in the suprachiasmatic nucleus which inhibits firing of specific neurons, which is thought to attenuate the alerting signal and allows the homeostatic mechanism to express itself and promote sleep.
Study participation is anticipated to be about 11 weeks (approximately 3 months).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325728
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|Study Director:||Medical Director Clinical Science||Takeda Global Research and Development|