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

Launched by UNIVERSITY OF TEXAS AT AUSTIN · Mar 10, 2017

Keywords

ClinConnect Summary

This clinical trial is investigating nighttime agitation in people with Alzheimer's disease, which can cause distress for both patients and their caregivers. Researchers want to find out if a sleep disorder called restless legs syndrome might be causing some of this agitation. They will be testing a medication called gabapentin enacarbil (also known as Horizant®) to see if it can help reduce nighttime agitation, improve sleep, and lessen restless legs symptoms. The goal is also to see if this treatment can decrease the need for stronger medications, like antipsychotics, which can have harmful side effects.

To participate in the trial, individuals must be at least 55 years old and have a diagnosis of Alzheimer's disease along with moderate to severe nighttime agitation. They should also have signs of restless legs syndrome. Participants will need to be stable in their health and able to take medications by mouth. Those currently taking certain medications or with specific health conditions may not be eligible. If you or a loved one fits these criteria, this trial could offer an opportunity to explore a new treatment option for managing nighttime agitation and improving overall well-being.

Gender

ALL

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
• • Opinion of the participant's physician that medication for agitation is appropriate
• • RLS diagnosis by study advanced practice nurse (APN) or registered nurse (RN) (in consult with the participant's physician, and the investigators), using the Behavioral Indicators Test-Restless Legs
• • Medically stable, defined as unchanged medications within 14 days and the absence of fever or other signs and symptoms of acute illness or delirium (e.g. urinary tract infection, pneumonia) that may cause agitation or interfere with the study protocol
• • Able to swallow medication
• • Ambulatory, with and without assistance
• • If currently being treated for RLS, may be included if still having RLS symptoms/signs and confirmed as appropriate for inclusion by medical review
• Exclusion Criteria:
• • Received \>= 50 morphine milligram equivalents per day (MME/d) in the 14 days prior to the randomization decision, because morphine and GEn taken together have a higher incidence of sedation and dizziness than either drug alone
• • Currently being treated for RLS with gabapentin or GEn
• • Diagnosis of Parkinson's disease (PD) or any other disorder causing tremor because extrapyramidal symptoms may confound RLS diagnosis and actigraphy
• • Receiving gabapentin
• • Severe psychosis
• • Alcohol consumption because combining alcohol and GEn may increase sedation and other adverse events
• • Treatment with GEn is contraindicated, such as when a potential participant is receiving multiple antiepileptic drugs, in the opinion of the study APN or RN, participant's physician, or study medical team
• • Failure of past treatment with gabapentin or GEn
• • Compromised renal function as indicated by creatinine clearance \<15 or on hemodialysis
• • Current participation in a clinical trial or in any study that may affect study outcomes
• • Determined to be at risk for suicide by the study APN, RN, or participant's physician
• • Any condition, that in the opinion of the study APN or RN, participant's physician, or study medical team, makes it medically inappropriate for the patient to enroll in the trial
• • Persons living independently in the community without a live-in caregiver (family or hired)