Alzheimer's Disease | Quetiapine for the Treatment of Insomnia in Alzheimer's Disease
Alzheimer's Disease research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: November 2005
Completed Date: January 2010
Primary Outcome: 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: Dose-response relationship of quetiapine and sleep in AD patients?
Study sponsors, principal investigator, and references
Principal Investigator: Clifford Singer, M.D.
Lead Sponsor: University of Vermont