RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-07-01

Study Completion:2023-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03082755

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Kathy Richards, PhD

CONTACT

7039463725

kricha@autexas.edu

Principal Investigator

Kathy Richards, PhD

PRINCIPAL_INVESTIGATOR

The University of Texas at Austin

Study Locations (Sites)

The University of Texas at Austin

Austin, Texas, 78701

United States

Collaborators and Investigators

Sponsor: University of Texas at Austin

Kathy Richards, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas at Austin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-07-01

Study Completion Date2023-03-31

Study Record Updates

Study Start Date2017-07-01

Study Completion Date2023-03-31

Terms related to this study

Additional Relevant MeSH Terms

Alzheimer Disease