RightFit
RecruitingPhase 4

Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Phone or video check-ins, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Social and physical activities may be restricted to television and phone calls, and exposure to bright outdoor light is likely infrequent or absent."
  • "A sample of 30 family caregivers will be recruited for qualitative phone interviews to explore the impact of social distancing on the well-being of older adults with Alzheimer's disease related dementia."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for people age 55 or older with Alzheimer's dementia, nighttime agitation, and restless legs syndrome, a sleep disorder that causes restless legs. It tests whether gabapentin enacarbil (Horizant) reduces nighttime agitation and restless leg behaviors, improves sleep, and lowers the use of antipsychotic medicines.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 55 or older, with Alzheimer's dementia diagnosed by a doctor.
  • Very mild to severe dementia, with a Clinical Dementia Rating score of 0.5–3.
  • Nighttime agitation, with a score of at least 35 on the study's agitation test.
  • Your doctor thinks medicine for agitation is appropriate.
  • A study nurse confirms restless legs syndrome using the study's test and input from the medical team.
  • Medicines have not changed for 14 days, and there is no fever, sudden illness, or sudden confusion that could affect the study.
  • Able to swallow medicine and walk, with or without help.
  • If already treated for restless legs syndrome, you still have symptoms and pass a medical review.

Who can't join

  • Took opioid pain medicines totaling at least 50 morphine milligram equivalents per day in the 14 days before the study group decision. This is a measure of opioid dose.
  • Currently taking gabapentin or gabapentin enacarbil, or either medicine failed to help in the past.
  • Parkinson's disease or another condition that causes shaking.
  • Severe psychosis, which can involve losing touch with reality, or a risk of suicide found by a nurse or doctor.
  • Drinking alcohol, which may increase sleepiness and other side effects with the study medicine.
  • Very poor kidney function, with creatinine clearance below 15, or receiving hemodialysis, a treatment that filters the blood.
  • Taking part in another clinical trial or a study that could affect the results, or having any condition or medicine use that the medical team considers unsafe for this trial.
  • Living independently without a family member or hired caregiver who lives with you.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (1)

TX