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Gamma-Aminobutyric Acid (GABA) Analog

Gabapentin Enacarbil for Alzheimer's Disease

Phase 4

Recruiting

Led By Kathy Richards, PhD

Research Sponsored by University of Texas at Austin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at 2 and 8 weeks

Awards & highlights

Study Summary

This trial is to study whether a sleep disorder, restless legs syndrome, may be a mechanism for nighttime agitation in Alzheimer's patients, and if treatment with gabapentin enacarbil (Horizant®) reduces nighttime agitation, improves sleep, reduces restless legs syndrome behaviors, and reduces antipsychotic medications.

Eligible Conditions

Alzheimer's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at 2 and 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at 2 and 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 2 and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Nighttime Agitation - Cohen Mansfield Agitation Inventory (CMAI) - Direct Observation

Secondary outcome measures

Nighttime Agitation - Cohen Mansfield Agitation Inventory (CMAI) - Caregiver Version.

Nighttime Agitation - Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC).

Sleep Disturbance - Behavioral Indicators Test - Restless Legs (BIT-RL)

+2 more

Other outcome measures

Fall Risk and Cognition - Global Rating of Fall Risk (GLORF)

Mini-Mental State Examination (MMSE)

Physical Mobility Scale (PMS)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Gabapentin Enacarbil (GEn)Experimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor

350 Previous Clinical Trials

80,828 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,669 Previous Clinical Trials

28,004,958 Total Patients Enrolled

Kathy Richards, PhDPrincipal InvestigatorThe University of Texas at Austin

1 Previous Clinical Trials

327 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any negative side effects to Gabapentin Enacarbil?

"Since this is a Phase 4 trial, meaning Gabapentin Enacarbil is an approved treatment, we estimate its safety to be a 3."

Answered by AI

Are there other examples of Gabapentin Enacarbil's medical efficacy?

"Currently, there are three clinical trials underway for the use of gabapentin enacarbil. None of these trials are in phase three. However, there are many studies based in Austin, Texas. In total, 24 locations are running trials for this treatment."

Answered by AI

Does this type of testing happen often?

"Research into Gabapentin Enacarbil began in 2016 with a study sponsored by XenoPort, Inc. This initial Phase 1 trial involved 144 people. After this first study in 2016, Gabapentin Enacarbil was approved for Phase 4 drugs. Currently, there are 3 ongoing trials across 14 cities and 1 country."

Answered by AI