NCT03082755 Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
| NCT ID | NCT03082755 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Texas at Austin |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 156 participants |
| Start Date | 2017-07-01 |
| Primary Completion | 2022-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 156 participants in total. It began in 2017-07-01 with a primary completion date of 2022-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Kathy Richards, PhD
PRINCIPAL INVESTIGATOR
The University of Texas at Austin
Frequently Asked Questions
Who can join the NCT03082755 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03082755 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03082755 currently recruiting?
Yes, NCT03082755 is actively recruiting participants. Contact the research team at kricha@autexas.edu for enrollment information.
Where is the NCT03082755 trial being conducted?
This trial is being conducted at Austin, United States.
Who is sponsoring the NCT03082755 clinical trial?
NCT03082755 is sponsored by University of Texas at Austin. The principal investigator is Kathy Richards, PhD at The University of Texas at Austin. The trial plans to enroll 156 participants.
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