Working… Menu

Quetiapine for the Treatment of Insomnia in Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00232570
Recruitment Status : Unknown
Verified May 2009 by University of Vermont.
Recruitment status was:  Recruiting
First Posted : October 4, 2005
Last Update Posted : May 5, 2009
National Center for Research Resources (NCRR)
Information provided by:
University of Vermont

Brief Summary:
The primary hypothesis is that quetiapine will improve sleep in persons with Alzheimer's Disease (AD), with higher doses producing greater total sleep time and sleep efficiency.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Insomnia Drug: quetiapine Not Applicable

Detailed Description:

Quetiapine is frequently used to treat psychosis in patients with Alzheimer's disease (AD) and other dementias. These patients commonly have sleep disturbances that include nighttime awakenings with confused, agitated behaviors. These awakenings impose a great challenge for caregivers, especially family caregivers whose own sleep is disrupted as a result of the patient's awakenings. Sleep disturbance can lead to nursing home placement3 and may add to cognitive impairment of patients.

There is no medication proven to be safe and effective in the treatment of sleep disorders in patients with dementia. Antipsychotic medications are often prescribed at bedtime in the hopes that they will aid sleep and reduce agitation and psychosis associated with these awakenings. Sleep disturbance is more common in AD patients with moderate to severe disease, and these patients are more likely to have psychosis and to be recruited from long-term care facilities. We recently conducted the only multicenter clinical trial of a drug for sleep disturbance in AD. The study, completed under the auspices of the NIA's Alzheimer's Disease Cooperative Study, investigated melatonin as a sedative-hypnotic agent for AD patients. We found melatonin to be of no benefit on objective measures, although there were positive trends in the data and a significant improvement on subjective measures (caregiver ratings of patients' sleep) in one of the melatonin groups relative to placebo. No other large trial in AD subjects has been reported in the literature for drugs with potential benefit for AD patients with sleep disturbances. There are several reasons why this population needs to be specifically studied. Patients with AD tend to have highly fragmented sleep, with many nocturnal awakenings. They have significant daytime sleepiness that might affect daytime cognitive function and behavior. These patients tend to be older, with sensitivity to drug side effects.

People with neurodegenerative diseases such as AD may respond differently to CNS-active medications. Finally, this population represents a large and growing cohort of patients that deserve individual study of their unique problems.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Quetiapine for the Treatment of Insomnia Associated With Alzheimer's Disease
Study Start Date : November 2005
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Quetiapine

Primary Outcome Measures :
  1. The primary objective is to determine whether quetiapine can increase total sleep time and reduce time awake in patients with AD and sleep disturbance.

Secondary Outcome Measures :
  1. Dose-response relationship of quetiapine and sleep in AD patients?
  2. Are there sleep architecture changes from quetiapine?
  3. Do the primary sleep variables change relative to placebo at any weekly time or dose point?
  4. Are caregivers, blind to treatment status, able to detect changes in sleep quality in the patients for quetiapine relative to placebo?
  5. Does quetiapine used at single bedtime dosing for potential nighttime soporific effect have a measurable impact on neuropsychiatric symptoms other than insomnia?

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 55-90 years.
  2. Diagnosis of possible or probable AD as defined by NINCDS-ADRD criteria.
  3. Sleep disturbance defined by mean score of 3 on first six items of the SDI.
  4. Family member able to provide surrogate informed consent.
  5. Live-in caregiver able to monitor medication and serve as informant on questionnaires.
  6. Caregiver who is fluent in English.
  7. Be able to ingest oral tablets.
  8. Be able to avoid caffeinated and alcoholic beverages during the study period.
  9. A neuroimaging study at the time of initial diagnosis, or any time since that is consistent with AD and effectively rules out dementia related only to stroke, hydrocephalus or other neurological condition.

Exclusion Criteria:

  1. Medical disorders that may account for sleep disturbance, especially delirium, Major Depressive Disorder (DSMIV) and severe or significant acute or chronic pain.
  2. Have acute or unstable medical conditions including renal failure, abnormal liver function, cardiac arrhythmia, sitting blood pressure below 110/70 or above 140/100 or postural blood drop 20 mm Hg.
  3. Symptoms suggesting other sleep disorders (e.g., periodic limb movement disorder, restless legs syndrome, obstructive sleep apnea syndrome), may be present but in the opinion of the PI, do not account for the primary symptoms of insomnia.
  4. Sleep disturbance symptoms that suggest a parasomnia. Parasomnias may include behavioral manifestations of epileptiform activity or REM Behavior Disorder (RBD).
  5. Previous treatment failure with quetiapine of AD-associated sleep disturbances, or intolerance of quetiapine in a previous treatment trial.
  6. Concomitant treatment with another antipsychotic or sedative-hypnotic medication, including trazodone.
  7. Evidence of a major mental disorder other than dementia, such as major depression or schizophrenia.
  8. Stable doses (for 4 weeks prior to study entry) of antidepressant, antiepileptic mood stabilizer, or acetylcholinesterase inhibitor medication will be allowed, but initiation or recent changes in the dose of such medications will be prohibited.
  9. Benzodiazepines within 2 weeks of study entry will not be allowed.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00232570

Layout table for location contacts
Contact: Sally Ross-Nolan, M.S. 802-847-9488
Contact: Francine Nanda, M.S. 802-847-8436

Layout table for location information
United States, Vermont
Fletcher Allen Health Care-Clinical Neuroscience Research Unit Recruiting
Burlington, Vermont, United States, 05401
Contact: Sally R. Nolan, M.S.    802-847-9488   
Contact: Francine Nanda, M.S.    802-847-8436   
Principal Investigator: Clifford Singer, M.D.         
Sponsors and Collaborators
University of Vermont
National Center for Research Resources (NCRR)
Layout table for investigator information
Principal Investigator: Clifford Singer, M.D. University of Vermont
Layout table for additonal information Identifier: NCT00232570    
Other Study ID Numbers: 05-234
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: May 5, 2009
Last Verified: May 2009
Keywords provided by University of Vermont:
sleep disturbance
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Sleep Initiation and Maintenance Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs