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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 18, 2022 (before its estimated August 31, 2022 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Mar 31, 2021 to Aug 31, 2022
    • Study completion date: Mar 31, 2022 to Mar 31, 2023
    • Site contact updated
    v10
  2. Eligibility criteria shortened, about 24 words
    • Secondary endpoints: details revised at 1 of 5 entries
    v9
  3. Enrollment target: 136 to 156
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study description expanded, about 398 words
    v8
  4. Re-verified, no change to tracked fieldsv7
  5. Eligibility criteria expanded, about 40 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site contact updated
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Secondary endpoints: details revised at 5 of 5 entries
    • Eligibility criteria expanded, about 3 words
    v5
  2. Eligibility criteria shortened, about 21 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Study description expanded, about 3 words
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 17, 2017 to Jul 1, 2017
    v3
  4. Start date: Jun 1, 2017 to Jul 17, 2017v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03082755
Lead Sponsor University of Texas at Austin
Collaborators: National Institute on Aging (NIA)
Conditions
(from sponsor)		 Alzheimer Disease
Related terms Alzheimer Disease
Enrollment 156 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov