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

NCT03082755 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2022-05-18

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

Placebo Oral Tablet

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

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Kathy Richards, PhD · The University of Texas at Austin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2022-08-31
Completion
2023-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03082755 on ClinicalTrials.gov