Testing gabapentin enacarbil for nighttime agitation in Alzheimer's disease
Tests gabapentin enacarbil against a placebo tablet in people with Alzheimer's disease.
Key facts
- Who runs it
- University of Texas at Austin
- Where
- Austin, United StatesSee the site
- Trial code
- Registry title
- Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 156 people, planned
- Started
- 1 Jul 2017
- Planned end
- 31 Mar 2023
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Gabapentin Enacarbil
- Placebo Oral Tablet
- Record updated
- 18 May 2022
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 55 or older with Alzheimer's disease who are agitated at night and have restless legs syndrome. It tests gabapentin enacarbil against a placebo.
- Age
- 55 years or older
- Sex
- All sexes can join
- Disease stage
- Alzheimer's dementia, very mild to severe (Clinical Dementia Rating 0.5-3), with nighttime agitation (Cohen Mansfield Agitation Inventory, Direct Observation total score >=35) and restless legs syndrome. Must be able to walk, with or without help.
- Earlier treatment
- People now treated for restless legs syndrome can join only if they still have symptoms. People taking gabapentin or gabapentin enacarbil cannot join. Medications must be unchanged for 14 days.
Main reasons for not taking part
- Parkinson's disease or another disorder that causes tremor
- Currently taking gabapentin, or past treatment with gabapentin or gabapentin enacarbil that failed
- Kidney function too low (creatinine clearance <15) or on hemodialysis
- Severe psychosis, alcohol use, or risk of suicide
- Living alone in the community without a live-in caregiver
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Receiving gabapentin
- 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
- Diagnosis of Parkinson's disease (PD) or any other disorder causing tremor because extrapyramidal symptoms may confound RLS diagnosis and actigraphy
- 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
- Compromised renal function as indicated by creatinine clearance <15 or on hemodialysis
- Currently being treated for RLS with gabapentin or GEn
- Severe psychosis
- Alcohol consumption because combining alcohol and GEn may increase sedation and other adverse events
- 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
- Persons living independently in the community without a live-in caregiver (family or hired)
Where in United States
- The University of Texas at AustinAustin, United StatesContact: Kathy Richards, PhDTaking people
About the trial
What the trial wants to find out
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 mechanism for nighttime agitation, and if treatment with gabapentin enacarbil (Horizant®) reduces nighttime agitation, improves sleep, reduces restless legs syndrome behaviors, and reduces antipsychotic medications.
The 2 groups in the trial
- Gabapentin Enacarbil (GEn)Treatment being tested
1 to 2 GEn tablets (300 mg) will be administered by mouth (PO) once a day in the evening (about 5 pm) for 8 weeks then tapered for 1 week. The study drug will be adjusted up to a maximum dosage of 600 mg as tolerated.
Treatment: Gabapentin Enacarbil
- PlaceboPlacebo, for comparison
1 to 2 Placebo Oral Tablet(s) will be administered once a day in the evening (about 5 pm) for 8 weeks then tapered for 1 week. The placebo drug will be adjusted up to a maximum dosage of 2 tablets as tolerated.
Treatment: Placebo Oral Tablet
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
- Plain-language title
- Testing gabapentin enacarbil for nighttime agitation in Alzheimer's diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 18 May 2022