Extension of CONCERT Protocol: Dimebon to treat Alzheimer’s disease

• Research type

  Research Study

• Full title

  AN OPEN-LABEL EXTENSION OF THE CONCERT PROTOCOL (DIM18) EVALUATING DIMEBON (LATREPIRDINE) IN PATIENTS WITH ALZHEIMER’S DISEASE

• IRAS ID

  55827

• Contact name

  Craig, W Ritchie

• Sponsor organisation

  Medivation, Inc.

• Eudract number

  2009-018121-75

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Alzheimer's disease (AD) is a fatal brain disorder that worsens over time causing areas of the brain to shrink. Symptoms include memory loss, major personality changes and loss of control over bodily functions. Approximately 26 million people worldwide suffer from AD.There is a need to develop new drugs that have a better therapeutic effect and/or an effect on the rate of disease progression.The therapeutic effect of Dimebon in AD patients was first suggested in a study conducted in Moscow, the results of which were published in a well respected medical journal called 'The Lancet'. The effects of Dimebon have since been reinforced in clinical studies sponsored by Medivation that support its development.Benefits from approved therapies are modest and don??t appear to affect the underlying disease process.This study is a continuation of CONCERT(DIM18), where patients on donepezil have been randomly assigned to either the Dimebon or placebo treatment groups. This proposed extension study aims to evaluate the long-term safety and tolerability of Dimebon in patients with AD. Therefore, patients who have successfully completed 52 weeks of blinded treatment in the CONCERT study will be offered the chance to participate in this extension study. All patients will receive Dimebon 10 mg three times per day (TID) for the first seven days of therapy, then Dimebon 20mg TID until marketing authorization. Patients will need to visit the study centre 6 weeks after starting the study then an additional 20 weeks later. Thereafter they will return to the study centre every 26 weeks until marketing authorization of Dimebon. They will receive study drug supply and undergo: physical exam; blood tests; and pregnancy test (for women of childbearing age).Medivation will be sponsoring the study, planned to run at approximately 110 centres worldwide across the US, Australia, New Zealand and Europe, including 15 UK study centres.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  10/H0308/62

• Date of REC Opinion

  24 Sep 2010

• REC opinion

  Further Information Favourable Opinion