Treatment of Subjects With Mild to Moderate Alzheimer's Disease and Sleep Treatment of Subjects Who Have Mild to Moderate Alzheimer's Disease and Sleep Disturbance With Rozerem™ - Full Text View

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00325728

Purpose

The purpose of the study is to determine if subjects with mild to moderate Alzheimer's Disease and sleep disturbance will benefit from treatment with Rozerem.

Condition	Intervention	Phase
Chronic Insomnia	Drug: Rozerem™ Drug: Placebo	Phase II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Sleep Disorders

Drug Information available for: Ramelteon

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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, Community Dwelling, Mild to Moderately Severe Alzheimer's Disease Subjects

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

To evaluate change in nighttime total sleep time with 8 mg of Rozerem™ or placebo every night at bedtime in sleep-disturbed, mild to moderately impaired AD subjects. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate changes from Baseline in 8mg of Rozerem™ compared with placebo on nighttime total sleep time, nighttime wake-time after sleep onset and number of nighttime awakenings. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
To evaluate changes from Baseline in 8mg of Rozerem™ compared with placebo on daytime total sleep time, ratio of daytime to nighttime sleep, number of daytime naps and sleep efficiency. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
To assess the safety and tolerability 8mg of Rozerem™ compared with placebo through laboratory tests, physical examinations, vital signs, electrocardiograms and monitoring of adverse events. [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]

Enrollment:	74
Study Start Date:	March 2006
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Rozerem™	Drug: Rozerem™ 8 mg Rozerem™ tablet, orally, once a night for 8 weeks.
2: Placebo Comparator Placebo	Drug: Placebo Placebo tablet, orally, once a night for 8 weeks.

Detailed Description:

The purpose of this study is to evaluate the efficacy, safety, and tolerability of 8 weeks treatment of Rozerem 8 mg (QHS) in sleep disturbed, community dwelling, mild to moderately severe Alzheimer's Disease subjects. The total duration of the study will be approximately 74 days, including 18 days of screening and 56 days of treatment. There will be initial subject screening, which will include medical history (including assessing severity of Alzheimer's Disease and sleep history), physical examination, laboratory tests, and an ECG recording for each subject. Subjects who meet the initial screening criteria will then undergo actigraphy monitoring for a period of 14 days to qualify for study participation. Screening will include administration of single-blind placebo medication.

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject has a clinical diagnosis of dementia of the Alzheimer's type (DSM-IV-TR) or probable Alzheimer's Disease by National Institute of Neurological and Communicative Disorders and Stroke/the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
The subject is aged 55 years or older.
The subject is residing in the same home with a primary caregiver.
The subject has a Mini-Mental State Examination score of 10 to 26, inclusive.
The subject has at Visit 1 a history of at least 2 sleep disorder behaviors, occurring at least once weekly over the past two weeks (as reported by the caregiver on the Sleep Disorder Inventory).
The subject qualifies for study participation based on actigraphy evidence collected during Screening.

Exclusion Criteria:

The subject is non-ambulatory, not community dwelling, wheel chair bound or confined to bed and is without a consistent caregiver present during the night who could function as the primary caregiver.
The subject has a history of significant stroke or vascular dementia.
The subject has at screening or randomization any clinically significant movement disorder.
The subject has co-morbid diagnosis of major depression as determined by the investigator or the subject's physician.
The subject has any pain syndrome affecting sleep in a clinically significant manner.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325728

Show 72 Study Locations

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

Sherry Weigand, MD, PhD

Takeda Global Research and Development

More Information

Responsible Party:	Takeda Global Research & Development Center, Inc. ( VP, Clinical Science )
Study ID Numbers:	01-05-TL-375-061
Study First Received:	May 11, 2006
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00325728
Health Authority:	United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:

Chronic Insomnia
Sleep Initiation and Maintenance Disorder
Drug Therapy
Alzheimer disease

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Alzheimer Disease
Sleep Disorders
Dyssomnias
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases

Cognition Disorders
Sleep Disorders, Intrinsic
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009