Alzheimer DiseasePhase 3NCT00000171
Study of Melatonin: Sleep Problems in Alzheimer's Disease
A Phase 3 study testing Melatonin in people with Alzheimer Disease and Dyssomnias, run by National Institute on Aging (NIA) at 31 sites in United States.
Trial summary
This protocol is a multicenter clinical trial of melatonin for sleep disturbances associated with Alzheimer's disease (AD). Frequent nocturnal awakening is a common behavioral symptom of AD. Nighttime wandering and agitated behavior may result in injuries and sleep disruption for caregivers. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer Disease, Dyssomnias
- What is being tested?
- Melatonin
- How many people
- Not given
- Where
- 31 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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
- Patients must meet NINCDS-ADRDA criteria for probable Alzheimer's disease (AD). Patients must have disrupted sleep, documented by clinical history and by 1 to 2 weeks of recording using wrist activity monitors.
- A diagnosis of probable AD.
- MMSE score 0-26.
- Hachinski Ischemia Scale score less than or equal to 4.
- A 2-week history of two or more sleep disorder behaviors, occurring at least once weekly, as reported by the caregiver on the Sleep Disorder Inventory.
- CT or MRI since the onset of memory problems showing no more than one lacunar infarct in a non-strategic area and no clinical events suggestive of stroke or other intracranial disease since the CT or MRI.
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- Physically acceptable for study as confirmed by medical history and exam, clinical laboratory results, and EKG.
- Actigraph evidence of a mean nocturnal sleep time of less than 7 hours per night (at least 5 nights of complete actigraph data must be collected over a single week.
- Stable home situation with no planned move during the 13-week investigational period.
- Residing with responsible spouse, family member, or professional caregiver who is present during the night and will agree to assume the role of the principal caregiver for the 13-week protocol, including arranging transport for the patient to and from the investigators' clinic, answering questions regarding the patient's condition, and assuming responsibility for medication and actigraph procedures.
- Ability to ingest oral medication and participate in all scheduled evaluations.
- Six grades of education or work history sufficient to exclude mental retardation.
- 55 years of age or older.
- Hamilton Depression Rating Scale score of 15 or less.
- Stable medication (dose and type) for non-excluded concurrent medical conditions for 4 weeks prior to the screening visit.
Who cannot join
- Sleep disturbance is acute (within the last 2 weeks).
- Sleep disturbance is associated with an acute illness with delirium.
- Clinically significant movement disorder that would interfere with the actigraph readings.
- Not having a mobile upper extremity to which to attach an actigraph.
- Severe agitation.
- Pain syndrome affecting sleep.
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- Unstable medical condition.
- Use of investigational or unapproved medications within 4 weeks of the screening visit.
- Patient unwilling to maintain caffeine abstinence after 2:00 pm for the duration of the protocol.
- Patient unwilling 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.
- Use of melatonin within 2 weeks of screening visit.
- Clinically significant abnormal laboratory findings that have not been approved by the Project Director.
- Residing in a facility without a consistent caregiver present during the night who can function as the primary informant.
- Caregiver deemed too unreliable to supervise the wearing of the actigraph, to maintain the sleep diary, or to bring the patient to the scheduled visits.
- Autoimmune disease, such as rheumatoid arthritis and polymyalgia rheumatica.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30329
Augusta VA Medical Center
Augusta, Georgia, 30904
Johns Hopkins University
Baltimore, Maryland, 21224
University Hospitals of Cleveland
Cleveland, Ohio, 44120
University of Texas
Dallas, Texas, 75235
Baylor College of Medicine
Houston, Texas, 77030
University of California Irvine Institute for Brain Aging and Dementia
Irvine, California, 92697-4285
Mayo Clinic Jacksonville
Jacksonville, Florida, 32225
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of California, San Diego
La Jolla, California, 92037
University of Kentucky
Lexington, Kentucky, 40536-0230
University of Southern California
Los Angeles, California, 90033-1039
University of California, Los Angeles
Los Angeles, California, 90095-1769
Mount Sinai (Miami)
Miami, Florida, 33140
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-8646
Yale University, Alzheimer's Disease ResearchUnit
New Haven, Connecticut, 06520-8037
New York University Medical Center
New York, New York, 10016
Columbia University
New York, New York, 11032
Brown University
Pawtucket, Rhode Island, 02860
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Health Sciences University
Portland, Oregon, 97201-3098
Mayo Clinic at Rochester
Rochester, Minnesota, 14620
University of Rochester Medical Center
Rochester, New York, 14620
University of Washington
Seattle, Washington, 98108
Southern Illinois University
Springfield, Illinois, 62702
Washington University
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida
University of Arizona
Tucson, Arizona, 85724-5023
About this study
This protocol is a multicenter clinical trial of melatonin for sleep disturbances associated with Alzheimer's disease (AD). Frequent nocturnal awakening is a common behavioral symptom of AD. Nighttime wandering and agitated behavior may result in injuries and sleep disruption for caregivers. Alternatives are sorely needed to the currently available sleep medications that have marginal efficacy and serious side effects. Melatonin is a naturally occurring hormone secreted by the pineal gland. It has soporific effects with oral administration and is well tolerated. It enhances sleep in normal older people. Melatonin also may help sleep disturbances associated with AD; however, this remains to be proven.
Read the detailed description
In Alzheimer's disease , sleep disruption is one of the most common behavioral problems, occurring in 45 percent of patients. These nocturnal awakenings and agitation lead to considerable burden for caregivers and frequently lead families to the decision of nursing home placement. The proposed study is a randomized, double blind, parallel group, placebo controlled, clinical trial. Placebo will be compared with two doses of melatonin: a 2.5 mg, slow- release preparation and a 10 mg immediate release preparation. One hundred and fifty community-residing AD patients with disrupted sleep will be recruited. Included subjects will meet NINCDS-ADRDA criteria for probable AD. Prior to study entry, disrupted sleep will be documented by clinical history and by 1 to 2 weeks of recording using wrist activity monitors. The treatment period will last 8 weeks. Rest/activity patterns will be recorded by wrist activity monitors. The primary outcome measure will be the change in nocturnal sleep time from baseline to the end of the treatment phase.
Other outcomes also will be examined, including the time awake after sleep onset, sleep latency, sleep efficiency, daytime agitation, and changes in cognition. The relative effectiveness of high and low dose melatonin will be assessed. Adverse events and side effects will be compared by treatment. This study should provide the data necessary to determine whether melatonin is a safe and effective treatment for disrupted sleep associated with AD.
- Conditions
- Alzheimer Disease, Dyssomnias
- Being tested
- Melatonin
- Keywords
- Alzheimer's disease, Sleep disorders, Melatonin
- Medical subject headings
- Alzheimer Disease, Dyssomnias, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 1999 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Cliff Singer, M.D., Study director, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000171
- Sponsor's protocol ID
- IA0006
- Other IDs
- 3U01AG010483-08S2
- Status last verified
- Mar 2005
- First submitted
- 29 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Singer C, Tractenberg RE, Kaye J, Schafer K, Gamst A, Grundman M, Thomas R, Thal LJ; Alzheimer's Disease Cooperative Study. A multicenter, placebo-controlled trial of melatonin for sleep disturbance in Alzheimer's disease. Sleep. 2003 Nov 1;26(7):893-901. doi: 10.1093/sleep/26.7.893.
PubMed 14655926McCleery 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Melatonin: Sleep Problems in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00000171
- Acronym / sponsor ID
- IA0006
- Conditions
- Alzheimer Disease, Dyssomnias
- Keywords
- Alzheimer's disease, Sleep disorders, Melatonin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- First posted
- 1 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol is a multicenter clinical trial of melatonin for sleep disturbances associated with Alzheimer's disease (AD). Frequent nocturnal awakening is a common behavioral symptom of AD. Nighttime wandering and agitated behavior may result in injuries and sleep disruption for caregivers. Alternatives are sorely needed to the currently available sleep medications that have marginal efficacy and serious side effects. Melatonin is a naturally occurring hormone secreted by the pineal gland. It has soporific effects with oral administration and is well tolerated. It enhances sleep in normal older people. Melatonin also may help sleep disturbances associated with AD; however, this remains to be proven.
Detailed description
In Alzheimer's disease , sleep disruption is one of the most common behavioral problems, occurring in 45 percent of patients. These nocturnal awakenings and agitation lead to considerable burden for caregivers and frequently lead families to the decision of nursing home placement. The proposed study is a randomized, double blind, parallel group, placebo controlled, clinical trial. Placebo will be compared with two doses of melatonin: a 2.5 mg, slow- release preparation and a 10 mg immediate release preparation. One hundred and fifty community-residing AD patients with disrupted sleep will be recruited. Included subjects will meet NINCDS-ADRDA criteria for probable AD. Prior to study entry, disrupted sleep will be documented by clinical history and by 1 to 2 weeks of recording using wrist activity monitors. The treatment period will last 8 weeks. Rest/activity patterns will be recorded by wrist activity monitors. The primary outcome measure will be the change in nocturnal sleep time from baseline to the end of the treatment phase.
Other outcomes also will be examined, including the time awake after sleep onset, sleep latency, sleep efficiency, daytime agitation, and changes in cognition. The relative effectiveness of high and low dose melatonin will be assessed. Adverse events and side effects will be compared by treatment. This study should provide the data necessary to determine whether melatonin is a safe and effective treatment for disrupted sleep associated with AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must meet NINCDS-ADRDA criteria for probable Alzheimer's disease (AD). Patients must have disrupted sleep, documented by clinical history and by 1 to 2 weeks of recording using wrist activity monitors.
- A diagnosis of probable AD.
- MMSE score 0-26.
- Hachinski Ischemia Scale score less than or equal to 4.
- A 2-week history of two or more sleep disorder behaviors, occurring at least once weekly, as reported by the caregiver on the Sleep Disorder Inventory.
Key exclusion criteria (15 listed)
- Sleep disturbance is acute (within the last 2 weeks).
- Sleep disturbance is associated with an acute illness with delirium.
- Clinically significant movement disorder that would interfere with the actigraph readings.
- Not having a mobile upper extremity to which to attach an actigraph.
- Severe agitation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 14655926Singer C, Tractenberg RE, Kaye J, Schafer K, Gamst A, Grundman M, Thomas R, Thal LJ; Alzheimer's Disease Cooperative Study. A multicenter, placebo-controlled trial of melatonin for sleep disturbance in Alzheimer's disease. Sleep. 2003 Nov 1;26(7):893-901. doi: 10.1093/sleep/26.7.893.
- Derived from this study: PubMed 33189083McCleery 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.
- The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA).Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cliff Singer, M.D. study director
Oregon Health and Science University
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Melatonin in people with Alzheimer Disease and Dyssomnias, run by National Institute on Aging (NIA) at 31 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 15 inclusion and 15 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000171, which also lists 2 linked publications.
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 24 Jun 2005.