Combined use of Dimebon and Donepezil to treat Alzheimer's disease

• Research type

  Research Study

• Full title

  A phase 3 multicentre, randomized, placebo-controlled, double-blind, twelve-month safety and efficacy study evaluating Dimebon in patients with mild-to-moderate Alzheimer's Disease on Donepezil

• IRAS ID

  19608

• Sponsor organisation

  Medivation, Inc.

• Eudract number

  2008-008005-21

• ISRCTN Number

  xx

• 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, personality and behavioural 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.Current treatment for AD involves increasing the brains natural chemicals such as 'acetylcholine'. Donepezil (also known as Aricept) is a drug used to treat AD which indirectly acts in this way. The proposed study will assess the safety and effectiveness of combining Dimebon and donepezil treatment. Participants will be in the study for up to 12 months. Upon enrollment participants will be randomly assigned to one of three treatment groups. Two groups will receive Dimebon (one at a higher dose and the other at a lower dose). The third group will receive placebo, a drug with no active substance in it. Participants will need to visit the study centre up to a total of nine times at which 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 worldwide, including the US, Australia, New Zealand and Europe. 15 study centres within the UK are expected to participate in the study.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  09/H0802/76

• Date of REC Opinion

  28 Jul 2009

• REC opinion

  Further Information Favourable Opinion