CANBiS-AD

• Research type

  Research Study

• Full title

  CANnabidiol for Behavioural Symptoms in Alzheimer’s Disease

• IRAS ID

  262408

• Contact name

  Latha Velayudhan

• Contact email

  latha.velayudhan@kcl.ac.uk

• Sponsor organisation

  King's College London

• Eudract number

  2019-002106-52

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  In the UK, around 850,000 people suffer from dementia, of which Alzheimer's disease (AD) accounts for approximately 62%. AD causes loss of brain cells, with behavioural and psychological symptoms (BPSD) often occurring as a result, causing major problems for the patient and their family.
  
  The purpose of this study is to test whether a new investigational medicine called cannabidiol is effective and safe in treating AD patients with BPSD. Cannabidiol (CBD) is extracted from the cannabis plant but is not responsible for the effects produced by cannabis, such as ‘feeling high’.

  The proposed trial will be a single-centre study involving the dementia services within the South London and Maudsley NHS Foundation. 40 participants will be recruited to this study where they will be enrolled for approximately 6-8 weeks; with a 6-week treatment period.

  This study will include 5 study visits and weekly telephone calls to monitor for adverse events, as well as changes in medical history and medications.

  At the baseline visit, participants will be randomly allocated to one of two treatment groups. One group will receive CBD capsules and the other group placebo capsules, for 42 days. If allocated the CBD capsules, the first week participant's will receive 200mg. This will then be increased to 400mg in week two and 600mg for the remaining four weeks.

  During visits, participants and caregivers will be asked to complete questionnaires to measure memory and any behavioural or psychological problems. We will also carry out physical examinations (including ECG), assess smell functioning and take samples of blood.

  To investigate the mechanism of action of CBD, we will examine the within-subject change in brain function and connectivity following treatment between the two groups. Neuroimaging will be offered to all participants and will be done pre-treatment and after 6 weeks of treatment.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  20/EE/0014

• Date of REC Opinion

  19 Mar 2020

• REC opinion

  Further Information Favourable Opinion