Investigating restless legs syndrome treatment for nighttime agitation in Alzheimer's patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to explore the relationship between restless legs syndrome (RLS) and nighttime agitation in individuals with Alzheimer's disease. The study will assess whether treating RLS with gabapentin enacarbil can reduce nighttime agitation, improve sleep quality, and decrease reliance on antipsychotic medications. Participants will undergo an 8-week intervention where they will receive either the medication or a placebo, with their agitation and sleep patterns closely monitored. The trial seeks to provide evidence on the effectiveness of targeting RLS as a potential cause of agitation in this population.

Why it matters

Who can join: the full rules

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)

Where it's running

• The University of Texas at Austin
  Austin, Texas, United States Recruiting

Study contacts

• Principal investigator: Kathy Richards, PhD — The University of Texas at Austin
• Study coordinator: Kathy Richards, PhD
• Email: kricha@autexas.edu
• Phone: 7039463725

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.