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
Overview
- Phase
- Phase 2
- Intervention
- Ramelteon
- Conditions
- Chronic Insomnia
- Sponsor
- Takeda
- Enrollment
- 74
- Primary Endpoint
- Mean Nighttime Total Sleep Time as determined by actigraphy.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to determine the efficacy of ramelteon, once daily (QD), in subjects with mild to moderate Alzheimer's Disease and sleep disturbance
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ramelteon 8 mg QD
Intervention: Ramelteon
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Mean Nighttime Total Sleep Time as determined by actigraphy.
Time Frame: Week 1
Secondary Outcomes
- Change from Baseline in Nighttime Total Sleep Time(Weeks 2, 4, 6, and 8 or Final Visit)
- Change from Baseline in Nighttime Wake After Sleep Onset per Actigraphy(Weeks 2, 4, 6, and 8 or Final Visit)
- Change from Baseline in Nighttime Number Of Awakenings per Actigraphy(Weeks 2, 4, 6, and 8 or Final Visit)
- Change from Baseline in Daytime Total Sleep Time(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.(Weeks 2, 4, 6, and 8 or Final Visit)
- Change from Baseline in Sleep Efficiency.(Weeks 2, 4, 6, and 8 or Final Visit)
- Percentage of subjects who experience Increase in Nighttime Total Sleep Time of 30 minutes.(Weeks 2, 4, 6, and 8 or Final Visit)
- Number of Daytime Naps.(Weeks 2, 4, 6, and 8 or Final Visit)