NCT03082755RecruitingPhase 4
Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 18 May 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- First submitted
- 6 Mar 2017
- Start date
- 1 Jul 2017
- Primary completion date
- 31 Aug 2022
- Lead sponsor
- University of Texas at Austin
- Diseases
- Alzheimer disease
- NCT number
- NCT03082755
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 156
- From 1 Jul 2017 to the primary completion date, 31 Aug 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Compromised renal function as indicated by creatinine clearance \<15 or on hemodialysis
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Texas at Austin Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.