Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease

Recruiting Phase 4 Interventional Study
Alzheimer Disease
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
55 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
156 (estimated)
Sponsor
University of Texas at Austin · Other
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About This Trial
Nighttime agitation in persons with Alzheimer's disease causes patient suffering, distresses caregivers, and often results in prescriptions for harmful antipsychotics. Effective treatments are lacking because of limited knowledge of the etiology of nighttime agitation. The investigators propose a clinical trial to better elucidate whether a sleep disorder, restless legs syndrome, may be a mechanis…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Aged \>=55 years * Clinical Dementia Rating (CDR) score of 0.5-3, indicating very mild to severe dementia * Physician diagnosis of dementia of the Alzheimer's type * Nighttime agitation, defined as Cohen Mansfield Agitation Inventory, Direct Observation total score \>=35 * Opi…
Contacts

Kathy Richards, PhD

7039463725

kricha@autexas.edu

CONTACT