Dimebon in Moderate-to-Severe Alzheimer’s Disease (DIM19)

• Research type

  Research Study

• Full title

  A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Six-Month Safety and Efficacy Study of Dimebon in Patients with Moderate-to-Severe Alzheimer’s Disease and Neuropsychiatric Symptoms

• IRAS ID

  26504

• Sponsor organisation

  Medivation Inc

• Eudract number

  2009-011799-31

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study is a multicenter Phase 3, randomized, double-blind, placebo-controlled safety and efficacy study of 6 months of dimebon treatment in patients with moderate-to-severe Alzheimer??s disease who are receiving donepezil background therapy. All eligible patients must have been treated with donepezil for at least six months and at a stable dose of donepezil 5 or 10 mg daily for at least four months prior to the Screening visit. Approximately 600 patients will be randomized to two groups of 300 patients each (dimebon, 20 mg three times daily, or placebo, three times daily). Patients will undergo assessments of their cognition and memory, ability to perform activities of daily living, and behaviour before beginning treatment and regularly during the 6-month treatment period. Patients who complete the 6-month study will be offered the opportunity to reconsent and to enrol into an extension study where all patients will receive dimebon until dimebon receives marketing authorization.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  09/H0502/103

• Date of REC Opinion

  2 Oct 2009

• REC opinion

  Further Information Favourable Opinion