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Chronic InsomniaPhase 2NCT00325728

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

A Phase 2 study testing Ramelteon in people with Chronic Insomnia, run by Takeda at 72 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Chronic Insomnia
What is being tested?
Ramelteon
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
72 sitesUnited States
Study dates
21 Mar 2006to 20 Aug 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • History of severe renal dysfunction or disease.
  • History of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study drug. (This criterion does not include those subjects with basal cell or Stage 1 squamous cell carcinoma of the skin.)
  • Any clinically significant movement disorder including but not limited to: akinesia, periodic limb movement disorder, restless leg syndrome, epilepsy, uncontrolled Parkinson's disease, or severe benign prostatic hyperplasia, cardiac asthma, chronic obstructive pulmonary disease.
  • Rapid eye movement behavior disorder or sleep apnea.
  • Any pain syndrome affecting sleep.
  • Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
  • Fluvoxamine
  • Melatonin
  • Rifampicin

Trial locations and contacts

72 sites in 1 country.

72 sites in 1 country

United States72 sites

  • Study site

    Alabaster, Alabama

  • Study site

    Albuquerque, New Mexico

  • Study site

    Atlanta, Georgia

  • Study site

    Beaufort, South Carolina

  • Study site

    Bellaire, Texas

  • Study site

    Bennington, Vermont

  • Study site

    Boston, Massachusetts

  • Study site

    Boynton Beach, Florida

  • Study site

    Bradenton, Florida

  • Study site

    Brooklyn, New York

  • Study site

    Brooksville, Florida

  • Study site

    Burlington, Vermont

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Columbus, Ohio

  • Study site

    Costa Mesa, California

  • Study site

    Darien, Connecticut

  • Study site

    Deerfield Beach, Florida

  • Study site

    Dover, New Hampshire

  • Study site

    Eugene, Oregon

  • Study site

    Fort Myers, Florida

  • Study site

    Fresno, California

  • Study site

    Grand Rapids, Michigan

  • Study site

    Greer, South Carolina

  • Study site

    Hallandale, Florida

  • Study site

    Havertown, Pennsylvania

  • Study site

    Hialeah, Florida

  • Study site

    Hollywood, Florida

  • Study site

    Honolulu, Hawaii

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Indianapolis, Indiana

  • Study site

    Irvine, California

  • Study site

    Jenkintown, Pennsylvania

  • Study site

    Largo, Florida

  • Study site

    Las Vegas, Nevada

  • Study site

    Lexington, Kentucky

  • Study site

    Los Angeles, California

  • Study site

    Miami, Florida

  • Study site

    Middleton, Wisconsin

  • Study site

    Moon Township, Pennsylvania

  • Study site

    Naples, Florida

  • Study site

    National City, California

  • Study site

    New Hyde Park, New York

  • Study site

    New York, New York

  • Study site

    North Charleston, South Carolina

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange City, Florida

  • Study site

    Oxnard, California

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Piscataway, New Jersey

  • Study site

    Pompano Beach, Florida

  • Study site

    Port Charlotte, Florida

  • Study site

    Princeton, New Jersey

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    Sarasota, Florida

  • Study site

    Savannah, Georgia

  • Study site

    St Louis, Missouri

  • Study site

    Stratford, New Jersey

  • Study site

    Sun City, Arizona

  • Study site

    Sunrise, Florida

  • Study site

    Tampa, Florida

  • Study site

    Toms River, New Jersey

  • Study site

    Tucson, Arizona

  • Study site

    Waterbury, Connecticut

  • Study site

    West Palm Beach, Florida

  • Study site

    West Yarmouth, Massachusetts

  • Study site

    Whiting, New Jersey

  • Study site

    Wichita Falls, Texas

Other trials in United States

About this 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, Mild to Moderately Severe Alzheimer's Disease Subjects

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

Read the 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).

Being tested
Ramelteon, Placebo
Keywords
Chronic Insomnia, Sleep Initiation and Maintenance Disorder, Drug Therapy, Alzheimer disease
Medical subject headings
Sleep Initiation and Maintenance Disorders, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RamelteonDrug

    Also called TAK-375, Rozerem

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

  • PlaceboDrug

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

Study groups in NCT00325728
Study groupRoleWhat they receive
Ramelteon 8 mg QDExperimentalNot described
Receives: Drug: Ramelteon
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Nighttime Total Sleep Time as determined by actigraphy.

    Measured: Week 1

Secondary outcomes (8)

  1. Change from Baseline in Nighttime Total Sleep Time

    Measured: Weeks 2, 4, 6, and 8 or Final Visit

  2. Change from Baseline in Nighttime Wake After Sleep Onset per Actigraphy

    Measured: Weeks 2, 4, 6, and 8 or Final Visit

  3. Change from Baseline in Nighttime Number Of Awakenings per Actigraphy

    Measured: Weeks 2, 4, 6, and 8 or Final Visit

  4. Change from Baseline in Daytime Total Sleep Time

    Measured: Weeks 2, 4, 6, and 8 or Final Visit

  5. Change from Baseline in the ratio of Daytime Total Sleep Time to Nighttime Total Sleep Time.

    Measured: Weeks 2, 4, 6, and 8 or Final Visit

  6. Change from Baseline in Sleep Efficiency.

    Measured: Weeks 2, 4, 6, and 8 or Final Visit

  7. Percentage of subjects who experience Increase in Nighttime Total Sleep Time of 30 minutes.

    Measured: Weeks 2, 4, 6, and 8 or Final Visit

  8. Number of Daytime Naps.

    Measured: Weeks 2, 4, 6, and 8 or Final Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2006 (estimated)
  2. Study start21 Mar 2006
  3. Primary completion1 Aug 2007
  4. Study completion20 Aug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00325728
Sponsor's protocol ID
01-05-TL-375-061
Other IDs
U1111-1115-1644
Status last verified
Aug 2017
First submitted
11 May 2006
Last updated
14 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33189083

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ramelteon in people with Chronic Insomnia, run by Takeda at 72 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Nighttime Total Sleep Time as determined by actigraphy. (time frame: Week 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00325728, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.

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