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™

Condition(s) targeted: Chronic Insomnia

Intervention: Rozerem™ (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Takeda Global Research & Development Center, Inc.

Official(s) and/or principal investigator(s):
Sherry Weigand, MD, PhD, Study Director, Affiliation: Takeda Global Research and Development

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome:

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.

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.

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.

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.

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Both.

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.

Alabaster, Alabama, United States

Huntsville, Alabama, United States

Phoenix, Arizona, United States

Sun City, Arizona, United States

Tuscon, Arizona, United States

Costa Mesa, California, United States

Fresno, California, United States

Irvine, California, United States

Los Angeles, California, United States

National City, California, United States

Oxnard, California, United States

San Diego, California, United States

San Francisco, California, United States

Darien, Connecticut, United States

Waterbury, Connecticut, United States

Boynton Beach, Florida, United States

Bradenton, Florida, United States

Brooksville, Florida, United States

Deerfield Beach, Florida, United States

Fort Myers, Florida, United States

Hallandale Beach, Florida, United States

Hialeah, Florida, United States

Hollywood, Florida, United States

Largo, Florida, United States

Miami, Florida, United States

Naples, Florida, United States

Orange City, Florida, United States

Pompano Beach, Florida, United States

Port Charlotte, Florida, United States

Sarasota, Florida, United States

Sunrise, Florida, United States

Tampa, Florida, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Savannah, Georgia, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Lexington, Kentucky, United States

Boston, Massachusetts, United States

West Yarmouth, Massachusetts, United States

Grand Rapids, Michigan, United States

St. Louis, Missouri, United States

Las Vegas, Nevada, United States

Dover, New Hampshire, United States

Manchester, New Jersey, United States

Piscataway, New Jersey, United States

Princeton, New Jersey, United States

Stratford, New Jersey, United States

Toms River, New Jersey, United States

Albuquerque, New Mexico, United States

Brooklyn, New York, United States

New Hyde Park, New York, United States

New York, New York, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Oklahoma City, Oklahoma, United States

Eugene, Oregon, United States

Havertown, Pennsylvania, United States

Jenkintown, Pennsylvania, United States

Moon Twp., Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Beaufort, South Carolina, United States

Greer, South Carolina, United States

N. Charleston, South Carolina, United States

Bellaire, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Wichita Falls, Texas, United States

Bennington, Vermont, United States

Burlington, Vermont, United States

Middleton, Wisconsin, United States

Starting date: March 2006
Ending date: August 2007
Last updated: June 10, 2008