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

NCT00325728 | Completed Phase 2

• 2 other identifiers: 01-05-TL-375-061U1111-1115-1644
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 72

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

Conditions

Chronic Insomnia

Keywords

Chronic Insomnia; Sleep Initiation and Maintenance Disorder; Drug Therapy; Alzheimer disease

Outcome Measures

Primary Outcomes (1)

• Mean Nighttime Total Sleep Time as determined by actigraphy.

  Week 1

Secondary Outcomes (8)

• 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

Study Arms (2)

Ramelteon 8 mg QD

EXPERIMENTAL

Drug: Ramelteon

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ramelteon DRUG

Ramelteon 8mg, tablets, orally, once nightly for up to 8 weeks.

Also known as: TAK-375, Rozerem

Ramelteon 8 mg QD

Placebo DRUG

Ramelteon placebo matching tablets, orally, once nightly for up to 8 weeks.

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of dementia of the Alzheimer's type (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised) or probable Alzheimer's disease by National Institute of Neurological and Communicative Disorders and Stroke/the Alzheimer's Disease and Related
• Disorders Association criteria.
• Female subjects must be post-menopausal.
• Stable residence with no planned move during the entire investigation period.
• Residing in the same residence with a responsible spouse, family member, or a professional caregiver who is present during the night who would agree to assume the role of the principal caregiver for the duration of the protocol period.
• Able to ingest oral medication and participate in all scheduled evaluations.
• Clinical laboratory evaluations (including clinical chemistry, hematology, and urinalysis) within the reference range as tested by the designated laboratory unless the results are deemed not clinically significant by the investigator or sponsor.
• Treatment medications for any non-excluded medications or concurrent medical conditions are stable for 30 days prior to the screening visit and medication(s) can in the investigator's judgment, remain stable throughout the duration of the study.
• Mini-Mental State Examination score of 8 to 28, inclusive.
• History of greater than or equal to 2 sleep disorder behaviors, occurring at least once weekly over the two weeks before screening.
• Actigraphy evidence shows a nighttime total sleep time of less than 7 hours per night based on at least 4 out of 7 nights of complete actigraphy data collected over the single-blind, placebo run-in period.
• Habitual bedtime of between 8 PM and 12 AM.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (72)

Unknown Facility

Alabaster, Alabama, United States

Location

Unknown Facility

Huntsville, Alabama, United States

Location

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Sun City, Arizona, United States

Location

Unknown Facility

Tucson, Arizona, United States

Location

Unknown Facility

Costa Mesa, California, United States

Location

Unknown Facility

Fresno, California, United States

Location

Unknown Facility

Irvine, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

National City, California, United States

Location

Unknown Facility

Oxnard, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Darien, Connecticut, United States

Location

Unknown Facility

Waterbury, Connecticut, United States

Location

Unknown Facility

Boynton Beach, Florida, United States

Location

Unknown Facility

Bradenton, Florida, United States

Location

Unknown Facility

Brooksville, Florida, United States

Location

Unknown Facility

Deerfield Beach, Florida, United States

Location

Unknown Facility

Fort Myers, Florida, United States

Location

Unknown Facility

Hallandale, Florida, United States

Location

Unknown Facility

Hialeah, Florida, United States

Location

Unknown Facility

Hollywood, Florida, United States

Location

Unknown Facility

Largo, Florida, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Naples, Florida, United States

Location

Unknown Facility

Orange City, Florida, United States

Location

Unknown Facility

Pompano Beach, Florida, United States

Location

Unknown Facility

Port Charlotte, Florida, United States

Location

Unknown Facility

Sarasota, Florida, United States

Location

Unknown Facility

Sunrise, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

West Palm Beach, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Savannah, Georgia, United States

Location

Unknown Facility

Honolulu, Hawaii, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

West Yarmouth, Massachusetts, United States

Location

Unknown Facility

Grand Rapids, Michigan, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

Dover, New Hampshire, United States

Location

Unknown Facility

Piscataway, New Jersey, United States

Location

Unknown Facility

Princeton, New Jersey, United States

Location

Unknown Facility

Stratford, New Jersey, United States

Location

Unknown Facility

Toms River, New Jersey, United States

Location

Unknown Facility

Whiting, New Jersey, United States

Location

Unknown Facility

Albuquerque, New Mexico, United States

Location

Unknown Facility

Brooklyn, New York, United States

Location

Unknown Facility

New Hyde Park, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Eugene, Oregon, United States

Location

Unknown Facility

Havertown, Pennsylvania, United States

Location

Unknown Facility

Jenkintown, Pennsylvania, United States

Location

Unknown Facility

Moon Township, Pennsylvania, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Beaufort, South Carolina, United States

Location

Unknown Facility

Greer, South Carolina, United States

Location

Unknown Facility

North Charleston, South Carolina, United States

Location

Unknown Facility

Bellaire, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Wichita Falls, Texas, United States

Location

Unknown Facility

Bennington, Vermont, United States

Location

Unknown Facility

Burlington, Vermont, United States

Location

Unknown Facility

Middleton, Wisconsin, United States

Location

Related Publications (1)

• McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.

  PMID: 33189083 DERIVED

Related Links

• Rozerem Package Insert

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Alzheimer Disease

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Officials

• Medical Director Clinical Science

  Takeda Global Research and Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2006
• First Posted: May 15, 2006
• Study Start: March 21, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 20, 2007
• Last Updated: August 14, 2017

Record last verified: 2017-08

Locations

US (72)