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Gabapentin Enacarbil for Alzheimer's Disease

The University of Texas at Austin, Austin, TX
Alzheimer's DiseaseGabapentin Enacarbil - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Similar Trials

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1
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AXS-05

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Change from baseline at 2 and 8 weeks

Week 8
Fall Risk and Cognition - Global Rating of Fall Risk (GLORF)
Mini-Mental State Examination (MMSE)
Nighttime Agitation - Cohen Mansfield Agitation Inventory (CMAI) - Caregiver Version.
Nighttime Agitation - Cohen Mansfield Agitation Inventory (CMAI) - Direct Observation
Nighttime Agitation - Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC).
Physical Mobility Scale (PMS)
Sleep Disturbance - Behavioral Indicators Test - Restless Legs (BIT-RL)
Sleep Disturbance - Direct Observation
Sleep Disturbance - Micro-Mini Motionlogger® Actigraph

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
Seltorexant
2
Active
3
AXS-05

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2 Treatment Groups

Gabapentin Enacarbil (GEn)
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

156 Total Participants · 2 Treatment Groups

Primary Treatment: Gabapentin Enacarbil · Has Placebo Group · Phase 4

Gabapentin Enacarbil (GEn)
Drug
Experimental Group · 1 Intervention: Gabapentin Enacarbil · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo Oral Tablet · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline at 2 and 8 weeks

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,487 Previous Clinical Trials
5,129,592 Total Patients Enrolled
University of Texas at AustinLead Sponsor
305 Previous Clinical Trials
69,451 Total Patients Enrolled
Kathy Richards, PhDPrincipal InvestigatorThe University of Texas at Austin
1 Previous Clinical Trials
327 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can swallow pills or tablets.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
65+100.0%
What site did they apply to?
The University of Texas at Austin100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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