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

Pivotal Trial

Drug Has Already Been Approved

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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 study objectives

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

Mini-Mental State Examination (MMSE)

Physical Mobility Scale (PMS)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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.

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