GN28525- EXTENSION STUDY MILD TO MODERATE ALZHEIMER’S DISEASE

• Research type

  Research Study

• Full title

  A MULTICENTER, OPEN-LABEL, LONG-TERM SAFETY EXTENSION OF PHASE II STUDIES ABE4869g AND ABE4955g IN PATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE

• IRAS ID

  115205

• Contact name

  Roger Bullock

• Sponsor organisation

  Genentech, Inc.

• Eudract number

  2012-003242-33

• Duration of Study in the UK

  3 years, 2 months, 11 days

• Research summary

  This is an extension study for patients with mild to moderate Alzheimer's disease who participated in and completed the treatment period of studies ABE4869g and ABE4955g.

  The primary objective of this study is to assess the long-term safety and tolerability of study drug crenezumab administered subcutaneously (SC) every 2 weeks (q2w) or intravenously (IV) every 4 weeks (q4w). Administered SC is an injection under the skin and IV is in the vein. All participants in this study will receive crenezumab.

  This is an approximately 105-week study that includes three phases: up to 14-day screening, 93-week treatment period, and 12-week follow-up period.

  This is a global study, approximately 390 patients will take part in this study at about 100 study centres in North America and Europe.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0723

• Date of REC Opinion

  30 Nov 2012

• REC opinion

  Further Information Favourable Opinion