NCT03082755.

Study name	Nighttime agitation and restless legs syndrome in people with Alzheimer's disease
Methods	RCT, 2‐arm parallel assignment, placebo‐controlled, double‐blind
Participants	136 nursing home residents with night‐time agitation, RLS, and moderate‐to‐severe AD
Interventions	Gabapentin enacarbil or placebo; 8 weeks
Outcomes	Primary: night‐time agitation (CMAI – direct observation). Secondary: night‐time agitation (CMAI‐caregiver and mADCS‐CGIC); sleep disturbance (direct observation and BIT‐RL and actigraphy). Actigraphic measures to include TNST, WASO, sleep efficiency, sleep latency, awakenings); fall risk (GLORF); cognition (MMSE); adverse event checklist
Starting date	2017
Contact information	Janet D Morrison, PhD; 512‐471‐8061; jmorrison@mail.nur.utexas.edu
Notes	ClinicalTrials.gov record accessed 22 April 2020 Study entry last updated 25 October 2019 – status: recruiting Estimated primary completion date 31 March 2021

ADAS‐cog: Alzheimer's Disease Assessment Scale – Cognitive Subscale; AD: Alzheimer's disease; BIT‐RL: Behavioral Indicators Test – Restless Legs; CMAI: Cohen‐Mansfield Agitation Inventory; CR: controlled release; DLB: dementia with Lewy bodies; dTST: daytime total sleep time; GLORF: Global Rating of Fall Risk; MMSE: Mini‐Mental State Examination; mADCS‐CGIC: Modified Alzheimer's Disease Cooperative Study‐Clinical Global Impression of Change; n: number of participants; NINCDS‐ADRDA: National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association; NPI: Neuropsychiatric Inventory; TNST: total nocturnal sleep time; PDD: dementia in Parkinson's disease; PSQI: Pittsburgh Sleep Quality Index; RCT: randomised controlled trial; REM: rapid eye movement; RLS: restless leg syndrome; SDI: Sleep Disorders Inventory; TNST: total nocturnal sleep time; TST: total sleep time; WASO: wakenings after sleep onset.