Quetiapine for the Treatment of Insomnia in Alzheimer's Disease

NCT00232570 | Unknown

• 1 other identifier: 05-234
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease; Insomnia

Keywords

sleep disturbance; dementia

Outcome Measures

Primary Outcomes (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 Outcomes (5)

• 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?

Interventions

quetiapine DRUG

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55-90 years.
• Diagnosis of possible or probable AD as defined by NINCDS-ADRD criteria.
• Sleep disturbance defined by mean score of 3 on first six items of the SDI.
• Family member able to provide surrogate informed consent.
• Live-in caregiver able to monitor medication and serve as informant on questionnaires.
• Caregiver who is fluent in English.
• Be able to ingest oral tablets.
• Be able to avoid caffeinated and alcoholic beverages during the study period.
• 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.

You may not qualify if:

• Medical disorders that may account for sleep disturbance, especially delirium, Major Depressive Disorder (DSMIV) and severe or significant acute or chronic pain.
• 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.
• 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.
• Sleep disturbance symptoms that suggest a parasomnia. Parasomnias may include behavioral manifestations of epileptiform activity or REM Behavior Disorder (RBD).
• Previous treatment failure with quetiapine of AD-associated sleep disturbances, or intolerance of quetiapine in a previous treatment trial.
• Concomitant treatment with another antipsychotic or sedative-hypnotic medication, including trazodone.
• Evidence of a major mental disorder other than dementia, such as major depression or schizophrenia.
• 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.
• Benzodiazepines within 2 weeks of study entry will not be allowed.

Sponsors & Collaborators

• University of Vermont: lead
• AstraZeneca: collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Fletcher Allen Health Care-Clinical Neuroscience Research Unit

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Sleep Initiation and Maintenance Disorders; Parasomnias; Dementia

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clifford Singer, M.D.

  University of Vermont

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sally Ross-Nolan, M.S.

CONTACT

802-847-9488; sally.nolan@vtmednet.org

Francine Nanda, M.S.

CONTACT

802-847-8436; francine.nanda@vtmednet.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: November 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: May 5, 2009

Record last verified: 2009-05

Locations

US (1)