LY2062430 versus Placebo in Alzheimer’s Disease

• Research type

  Research Study

• Full title

  Protocol H8A-MC-LZAN Effect of Passive Immunization on the Progression of Alzheimer’s Disease: LY2062430 versus Placebo

• IRAS ID

  19295

• Contact name

  Roger Bullock

• Contact email

  Roger.Bullock@awp.nhs.uk

• Sponsor organisation

  Eli Lilly

• Eudract number

  2008-007926-21

• ISRCTN Number

  N/A

• Research summary

  Study H8A-MC-LZAN (LZAN) is a multicenter, randomized, double-blind, placebo controlled, Phase 3 study comparing LY2062430 and placebo for 18 months in approximately 1000 patients with mild to moderate Alzheimer’s disease. Patients who meet entry criteria will be randomized in a 1:1 ratio (500 per treatment arm) to LY2062430 400 mg once every 4 weeks or placebo. Patients will be randomized by site and by mild or moderate MMSE scores (for the purposes of this study, moderate will be defined as scores including 16 through 19, and mild as including 20 through 26). The primary hypothesis being tested is that LY2062430 will slow cognitive and functional decline in Alzheimer’s disease as compared with placebo.

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/67

• Date of REC Opinion

  23 Jul 2009

• REC opinion

  Further Information Favourable Opinion