Extended use of Dimebon in the treatment of Alzheimer’s disease

• Research type

  Research Study

• Full title

  CONNECTION PLUS: AN OPEN-LABEL EXTENSION OF THE CONNECTION PROTOCOL (DIM14) EVALUATING ORAL DIMEBON IN PATIENTS WITH ALZHEIMER’S DISEASE

• IRAS ID

  16199

• Sponsor organisation

  Medivation, Inc.

• Eudract number

  2008-006352-22

• ISRCTN Number

  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.Benefits from approved therapies are modest and don??t appear to affect the underlying disease process. 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 has been reinforced in clinical studies sponsored by Medivation that support its clinical development.This study is a continuation of another study, the CONNECTION (DIM14), were patients 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 26 weeks of blinded treatment in the CONNECTION 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 6 weeks later. Thereafter they will return to the study centre every 13 weeks until marketing authorization of Dimebon. They will receive study drug supply and undergo the following: physical exam; electrocardiogram; blood tests; urine test; pregnancy test (for women who can have children); questions that test mood and thinking ability.Medivation, Inc. will be sponsoring the study. It is planned to run the study at approximately 100 centres across North and South America and Europe including 6 study centres in the UK.

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/52

• Date of REC Opinion

  8 Jun 2009

• REC opinion

  Further Information Favourable Opinion