The LUCIDITY Study

• Research type

  Research Study

• Full title

  Randomised, Double-Blind, Placebo-Controlled, Three-Arm, 12-Month, Safety and Efficacy Study of Hydromethylthionine Mesylate (LMTM) Monotherapy in Subjects with Alzheimer’s Disease Followed by a 12 Month Open-Label Treatment

• IRAS ID

  237139

• Contact name

  Catherine Carter

• Contact email

  catherine.carter@parexel.com

• Sponsor organisation

  TauRx Therapeutics Ltd

• Eudract number

  2017-003558-17

• ISRCTN Number

  ISRCTN00000000

• Clinicaltrials.gov Identifier

  NCT03446001

• Duration of Study in the UK

  1 years, 0 months, 13 days

• Research summary

  Leuco-methylthioninium bis(hydromethanesulfonate) (also known as LMTM) is an experimental drug that is being tested to see if it will work for the treatment of Alzheimer’s disease. LMTM is experimental because it is not currently approved for treatment of Alzheimer’s disease and can only be used in clinical research studies.
  The purpose of the study is to find out what effects, good or bad, LMTM has on participants and their Alzheimer’s disease. Participants are being asked to take part in this study because they have mild Alzheimer’s disease and are not taking any other medicines for this.

  Participants will be randomly placed into one of the following two groups:

  • If they are in group 1 (about 90 participants): they will be given one 4 mg LMTM tablet two times a day (a total of 8 mg of LMTM per day).
  • If they are in group 2 (about 90 participants): they will be given one placebo tablet two times a day.

  The treatment will be “blinded”. This means the participant, their study doctor, and their caregiver will not know which group they are in. Participants are expected to be in the study for up to 36 weeks (for a total of up to 9 months). This includes up to 6 weeks of screening, 26 weeks of taking study drug and a follow-up period 4 weeks after the last dose. However, if there are scheduling changes or extensions of time between visits, this could be longer than 36 weeks (9 months). During the course of this study participants will undergo various tests, questionnaires and brain scans.

  About 180 participants will take part in this study at hospitals and private clinics in North America and Europe.

  This study is being sponsored by TauRx Therapeutics Ltd.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  18/LO/0040

• Date of REC Opinion

  25 Feb 2018

• REC opinion

  Further Information Favourable Opinion