Quetiapine for the Treatment of Insomnia in Alzheimer's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University of Vermont.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
AstraZeneca
Information provided by:
University of Vermont
ClinicalTrials.gov Identifier:
NCT00232570
First received: September 30, 2005
Last updated: May 4, 2009
Last verified: May 2009
  Purpose

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 Intervention
Alzheimer's Disease
Insomnia
Drug: quetiapine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Quetiapine for the Treatment of Insomnia Associated With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by University of Vermont:

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

Estimated Enrollment: 18
Study Start Date: November 2005
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232570

Contacts
Contact: Sally Ross-Nolan, M.S. 802-847-9488 sally.nolan@vtmednet.org
Contact: Francine Nanda, M.S. 802-847-8436 francine.nanda@vtmednet.org

Locations
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    sally.nolan@vtmednet.org   
Contact: Francine Nanda, M.S.    802-847-8436    francine.nanda@vtmednet.org   
Principal Investigator: Clifford Singer, M.D.         
Sponsors and Collaborators
University of Vermont
AstraZeneca
Investigators
Principal Investigator: Clifford Singer, M.D. University of Vermont
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00232570     History of Changes
Other Study ID Numbers: 05-234
Study First Received: September 30, 2005
Last Updated: May 4, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Vermont:
sleep disturbance
dementia

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014