Clinical Trial Details

NCT ID: NCT00232570
Date Last Changed: May 4, 2009


Research Study Summary

Patients are needed to participate in a clinical research study evaluating quetiapine for the treatment of Alzheimer's Disease or Insomnia

Research Study Title

Quetiapine for the Treatment of Insomnia Associated With Alzheimer's Disease


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.

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Recruitment Details

Both Male and Female
55 to 90 Years
Overall Status
Lead Sponsor
University of Vermont
49 Months
Facility Type


Both Male and Female ages 55 Years to 90 Years

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.

Site Locations (1)

Country State City Zip Facility and Contact
United States Vermont Burlington 05401 Fletcher Allen Health Care-Clinical Neuroscience Research Unit
Sally R. Nolan, M.S.

Clifford Singer, M.D.
Principal Investigator


Sally Ross-Nolan, M.S.

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