PROTOCOL BP28248 PATIENTS WITH MODERATE SEVERITY ALZHEIMER’S DISEASE

• Research type

  Research Study

• Full title

  A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF RO4602522 ADDED TO THE BACKGROUND THERAPY OF THE ACETYLCHOLINESTERASE INHIBITORS DONEPEZIL OR RIVASTIGMINE IN PATIENTS WITH MODERATE SEVERITY ALZHEIMER’S DISEASE

• IRAS ID

  108990

• Contact name

  Craig Ritchie

• Sponsor organisation

  Roche Products Limited

• Eudract number

  2012-000943-29

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study aims to investigate the efficacy and safety of study drug RO4602522 compared to placebo added to the Background therapy of the Acetylcholinesterase Inhibitors Donepezil or Rivastigmine in patients with moderate severity Alzheimer‘s disease (AD). The study has a 45-day screening period, followed by a 12-month treatment period, and then a 3-month follow-up period. If eligible for the study participants will be randomly assigned in equal ratio (1:1:1) to one of the following three treatments: - placebo,- RO4602522 1 mg - RO4602522 5 mg as add-on to a background therapy of donepezil (5 mg/day to 10 mg/day) or rivastigmine (4.6 mg/24h or 9.5 mg/24h patch).This is a global study; at least 420 patients will be enrolled. There will also be two optional research studies. For one, additional blood samples will be collected from consenting patients to determine how RO4602522 works in the body and how people respond differently to RO4602522. This is known as the optional PK study. The second optional study is the RCR study. The sponsor may use some of the blood samples for research about genetic (inherited) factors and how people respond to the drug. There is a separate consent process/information sheet and informed consent form for patients who agree to each of these optional studies. Patients can choose to agree to either, both or neither of the optional research studies, or not and are still eligible for enrolment in the main study.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  12/SC/0687

• Date of REC Opinion

  28 Feb 2013

• REC opinion

  Further Information Favourable Opinion