Recruiting

Observational Study

Sponsor:

University of Texas at Austin

Code:

NCT03082755

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Gabapentin Enacarbil

Placebo Oral Tablet

Study Details

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.

Conditions

Alzheimer Disease

Study ID

NCT03082755

Start date

Jul 1, 2017

Status verified date

May, 2022

Completion date

Mar 31, 2023

Anticipated

Primary completion date

Aug 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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 Design

Enrollment

156 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Gabapentin Enacarbil (GEn)

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.

placebo comparator: Placebo

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.

Interventions

Gabapentin Enacarbil

1 to 2 GEn tablets (300 milligrams per tablet) will be administered once a day in the evening (about 5pm) for 8 weeks.

Placebo Oral Tablet

1 to 2 Placebo Oral Tablets will be administered once a day in the evening (about 5pm) for 8 weeks.

Primary outcome measure

  • Nighttime Agitation - Cohen Mansfield Agitation Inventory (CMAI) - Direct Observation [ Time Frame: Change from baseline at 2 and 8 weeks ]

Central Contacts and Locations

Central contacts

Kathy Richards, PhD

7039463725kricha@autexas.edu

Locations

The University of Texas at Austin

Recruiting

Austin, Texas, United States, 78701

Contacts

Kathy Richards, PhD

512-232-1131kricha@utexas.edu

Kathy Richards, PhD

703-946-3725kricha@utexas.edu

More Information

Sponsor

University of Texas at Austin

Last update posted

May 18, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2022-05-18.