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

Part of paid clinical trials in Austin, Texas.

Sponsor
University of Texas at Austin
Study ID
NCT03082755
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 1, 2017
Status verified
May 2022
Primary completion
Aug 31, 2022
Completion
Mar 31, 2023

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas at AustinAustinTexas78701
Kathy Richards, PhD
[email protected]
512-232-1131
Kathy Richards, PhD
[email protected]
703-946-3725

Find similar trials in Austin, TX

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
The University of Texas at Austin· Austin, TX

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