Investigating restless legs syndrome treatment for nighttime agitation in Alzheimer's patients
Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
This study is testing if a medication for restless legs syndrome can help reduce nighttime agitation and improve sleep in people with Alzheimer's disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | University of Texas at Austin Academic / other |
| Locations | 1 site (Austin, Texas) |
| Trial ID | NCT03082755 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55 and older with a physician-confirmed diagnosis of Alzheimer's disease and experiencing significant nighttime agitation.
Not a fit: Patients who do not have a diagnosis of restless legs syndrome or those with acute illnesses that may cause agitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective treatments for nighttime agitation in Alzheimer's patients, improving their quality of life.
How similar studies have performed: Previous studies have indicated a link between restless legs syndrome and nighttime agitation in dementia patients, suggesting that this approach may hold promise.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Austin, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.