CAD106A2201E - Extension study using CAD106 in Alzheimer's Disease

• Research type

  Research Study

• Full title

  An open-label extension to a 52-week, multi-center, randomized, double-blind, placebo-controlled, parallel group study in patients with mild Alzheimer’s Disease (AD) to investigate the safety and tolerability of repeated subcutaneous injections of CAD106

• IRAS ID

  31336

• Contact name

  Clive Holmes

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2009-012395-27

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Alzheimer's Disease (AD) is one of the most common neurological disorders among the elderly worldwide.Current therapies aim to control the symptoms of AD. CAD106 is a new medicine that aims to prevent the disease.In AD, patients have certain protein deposits on their brain which are thought to disrupt brain function and cause the memory problems associated with AD. CAD106 has been shown to initiate the removal of these protein deposits in animal studies.Each patient who completes the core study (CCAD106A2201) and who meet inclusion criteria, will be invited to join this extension study. The Investigator will need to ensure that all study assessments from the final (week 52) assessment of the core study are normal before patients can be screened for this study. Patients who agree and provide informed consent will all receive the active study drug.Patients who agree to receive the study drug will visit the clinic a minimum of 12 times. There are also 5 scheduled telephone contact assessments during the treatment and follow-up period of the study ( 66 weeks). The protocol allows these telephone contacts to be clinic visits if required. There is a further 2 years follow-up period to collect any Serious Adverse Event Data. The Patients who are not eligible to enter the study at the screening visit or who do not consent to receiving the study injections will be asked to directly enter the 2 year period to collect Serious Adverse Event data after completing the core study CCAD106A2201.The study is being run by Novartis Pharma AG. Approximately 27 patients from across Europe will be recruited into the study, (2 from the UK).

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  09/H0502/112

• Date of REC Opinion

  11 Dec 2009

• REC opinion

  Further Information Favourable Opinion