RVT-101 in subjects with dementia with Lewy bodies (DLB)

• Research type

  Research Study

• Full title

  A Phase 2b, double-blind, randomized, placebo-controlled study of RVT-101 in subjects with dementia with Lewy bodies (DLB)

• IRAS ID

  202345

• Contact name

  Ian McKeith

• Contact email

  Ian.McKeith@newcastle.ac.uk

• Sponsor organisation

  Axovant Sciences, Inc.

• Eudract number

  2015-005495-19

• Clinicaltrials.gov Identifier

  NCT02669433

• Clinicaltrials.gov Identifier

  IND # , 127,379

• Duration of Study in the UK

  1 years, 5 months, 0 days

• Research summary

  This is a phase 2b clinical research study of an Investigational Product called RVT-101 in participants with dementia with Lewy bodies (DLB).

  DLB is a type of progressive dementia primarily affecting older adults. Currently there are no approved medical treatments for DLB in Europe.

  RVT-101 is being tested in this study to evaluate whether it can help cognition, overall function and to investigate the safety of RVT-101 in participants with dementia with Lewy bodies. RVT-101 is not approved for use in any country.

  This research study will include about 240 participants, from approximately 50 study sites globally. Participants will be randomly
  assigned to one of three groups: 70 mg RVT-101, 35 mg RVT-101 or placebo (dummy drug). UK participants will be assigned to the 70 mg group only after safety data from an initial group of study patients are reviewed. The participant, caregiver or study doctor will not know which treatment they are assigned to.

  Study participation will last approximately 32 weeks. If, after screening, participants qualify to take part, they will come to the study centre for 12 study visits. In addition to this, a study visit for safety follow-up tests will be performed 2 weeks after the final visit.
  The study involves procedures including: medical history, physical exams, temperature, blood pressure, heart rate, breathing rate, weight, height, neurological exams, questionnaires and tests to assess DLB, blood tests, urine tests, and recordings of the heart, questions about how the participant is feeling and about medications they are taking. Additionally, some patients may require an MRI scan of the brain.

  This study is sponsored by Axovant Sciences Ltd.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  16/NE/0191

• Date of REC Opinion

  2 Aug 2016

• REC opinion

  Further Information Favourable Opinion