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NCT03082755 · ClinicalTrials.gov registry record · Phase 4
Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
A Phase 4 study of Alzheimer Disease, sponsored by University of Texas at Austin.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 156
- Enrollment target
- 1
- Study location
NCT03082755: Recruiting Phase 4 study of Alzheimer Disease, sponsored by University of Texas at Austin.
NCT03082755 is a Phase 4 study of Alzheimer Disease that is actively recruiting participants, run by University of Texas at Austin. The registered enrollment target is 156 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03082755, a Phase 4 study of Alzheimer Disease, is actively recruiting participants, sponsored by University of Texas at Austin.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 156 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The CMAI, modified for direct nighttime observation, will be used to collect objective data on nighttime agitation. Research Assistants (RAs) continuously observe the persons with dementia and record agitation behaviors every 5 minutes. The measure requires that the RAs first note whether the participant is behaviorally awake or asleep. Sleep is defined as a quiet state with eyes closed. Nighttime agitation behaviors are scored during wake. The RA will directly observe the participant when he, o
Conditions Studied
Interventions
- DRUG Placebo Oral Tablet
- DRUG Gabapentin Enacarbil
Study Locations (1)
Texas
- The University of Texas at Austin - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 4 |
What NCT03082755 shows while recruiting
NCT03082755 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT03082755 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03082755 about?
NCT03082755 is a clinical study titled "Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease". 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 cl...
What is the current status of trial NCT03082755?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 156 participants. The study started on 2017-07-01. Estimated completion is 2023-03-31.
What conditions does trial NCT03082755 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT03082755?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Gabapentin Enacarbil (DRUG).
Who is sponsoring clinical trial NCT03082755?
This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03082755 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03082755's enrollment target sits among peer trials
156 128th of 306 higher than 179 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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