Lemborexant in subjects with ISWRD and Alzheimer’s

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects with Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer’s Disease Dementia

• IRAS ID

  234487

• Contact name

  Craig Ritchie

• Contact email

  craig.ritchie@ed.ac.uk

• Sponsor organisation

  Eisai Ltd.

• Eudract number

  2017-003306-40

• Clinicaltrials.gov Identifier

  NCT03001557

• Duration of Study in the UK

  0 years, 7 months, 31 days

• Research summary

  Sleepiness can substantially impact quality of life for a patient with dementia. Sleep-wake disturbances are a very common and often disabling feature of Alzheimer’s Disease - Dementia (AD-D).
  
  There are currently no treatments approved for Irregular Sleep-Wake Rhythm Disorder (ISWRD). Benzodiazepine and non-benzodiazepine can cause confusion, slow reaction, and worsen balance, leading to falls.
  
  There have been 9 clinical trials with approximately 350 subjects who have taken lemborexant. Overall, data from the studies to date have shown an acceptable safety and tolerability profile of lemborexant, efficacy on both objective and subjective measures of sleep onset and sleep maintenance.
  
  This study will evaluate the effects of daily lemborexant doses for 4weeks in subjects with mild / moderate AD-D who complain of disrupted sleep or multiple awakenings. In addition to actigraphy (non-invasive method of monitoring human rest/activity cycles), psychometric assessments will be administered to evaluate effects on well-being of both the subject and the caregiver. Recruitment will predominantly be patients with mild to moderate form of the disease and the initial contact will be performed by the clinical care team.
  
  There are 2 phases:
  1. The Prerandomisation Phase will comprise 2 periods that will last up to a maximum of 42days: a Screening and Baseline Period. The screening procedures will include assessment of the subject’s medical history, symptoms of their disease, laboratory tests, ECG, heart rate, and blood pressure. Subjects will be required to wear a device registering their activity.
  2. The Randomisation Phase will comprise a Treatment Period during which subjects will be treated for 4week and a minimum 14-day Follow-Up Period before an End of Study visit. A polysomnogram will be performed at baseline. Throughout both phases subjects will undergo routine safety assessments, including questioning regarding AEs; suicidality; 12-lead electrocardiograms; vital signs, weight; clinical haematology and chemistry analysis; and urinalysis.

• REC name

  Scotland A: Adults with Incapacity only

• REC reference

  18/SS/0002

• Date of REC Opinion

  27 Feb 2018

• REC opinion

  Further Information Favourable Opinion