ABE4869g-Phase II study of MABT5102A vs Placebo in Alzheimer’s Disease

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo controlled, Parallel Group, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of MABT5102A in Patients with Mild to Moderate Alzheimer’s Disease.

• IRAS ID

  63786

• Sponsor organisation

  Genentech Inc.

• Eudract number

  2010-021926-37

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  Phase II randomized double-blind placebo-controlled study to evaluate safety and efficacy of MABT5102A (an antibody that binds and helps remove the abnormal protein amyloid which accumulates in the brain in AD ) in patients diagnosed with mild to moderate Alzheimer's Disease in approximately 372 patients 50-80y old in North America and EuropeThis study will test both subcutaneous (under skin), and intravenous injection of the study drug over 90 weeks ( 68 weeks treatment and 16 weeks follow-up) Safety will be assessed with regular blood tests MRI and physical exams. Participants will be randomly allocated to receive either MABT5102A or placebo.The study will be conducted in 2 parts:Part 1 ~180 patients will be randomized at a 2:1 ratio (active to placebo) to receive either MABT5102A or placebo via subcutaneous injection every 2 weeks.Part 2 ~180 patients will be randomized at a 2:1 ratio (active to placebo) to receive either MABT5102A or placebo via intravenous infusion every 4 weeks.Safety data will be collected from all enrolled patients (included withdrawn and/or discontinued) for >90 days after last dose.A safety run-in assessment will be conducted in approximately 12 patients in US. It will begin at the start of Part l. Part 2 will begin when the safety run-in and full enrolment of Part 1 is completed. Patients will be randomized at a 5:1 ratio (active to placebo to receive either MABT5102A or placebo via monthly intravenous infusion.Adverse events, serious adverse events eg allergic reactions to the injections and any change in cognitive or neurological function and laboratory abnormalities will be assessed by an internal Safety Monitoring Committee. The Medical Monitor will be supported by a blinded external Scientific Oversight Committee (includes an external radiologist and neurologist/psychiatrist) for evaluation of cerebral vasogenic oedema (VE), superficial siderosis and micro- and macrohaemorrhages as assessed by MRl.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  11/LO/0454

• Date of REC Opinion

  25 Jul 2011

• REC opinion

  Further Information Favourable Opinion