Phase 3 IGIV, 10% in AD

• Research type

  Research Study

• Full title

  A PHASE 3 RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFECTIVENESS OF IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% SOLUTION (IGIV, 10%) FOR THE TREATMENT OF MILD TO MODERATE ALZHEIMER’S DISEASE (AD)

• IRAS ID

  114869

• Contact name

  Roger Bullock

• Sponsor organisation

  Baxter Innovations GmbH

• Eudract number

  2011-000914-21

• Clinicaltrials.gov Identifier

  NCT01524887

• Research summary

  Alzheimer??s disease (AD) is a permanent progressive disease of the brain which means that slowly over time more parts of the brain are damaged. It is the most common cause of dementia. The term dementia describes a number of symptoms such as loss of memory and thinking ability. Recent report published by Alzheimer??s Disease International (ADI) estimates about 35.6 million people are suffering from Alzheimer??s disease. The cause of Alzheimer??s disease is not yet fully understood but researchers agree that there may be a number of factors including genetic (inherited) that contribute to the development of the disease. Currently a group of drugs called acetylcholinesterase inhibitors and an N-methyl-D aspartic acid (NMDA) are used to treat Alzheimer??s disease. This group of medications can briefly improve thinking ability in Alzheimer??s patients or they can slow the progression of the loss of thinking ability, however most patients receiving these medications decline below their pre-treatment starting point within 6 to 12 months of receiving treatment. Therefore more effective treatment is needed to treat Alzheimer??s disease. Baxter Healthcare Corporation/Baxter Innovations GmbH is developing an alternative treatment called Immune Globulin Intravenous (Human), 10% Solution (IGIV, 10%). IGIV, 10% is obtained from plasma (a liquid component of blood) of healthy blood donors and contains special proteins called ??antibodies? that help protect the body against infection and other illnesses. IGIV, 10% is approved to treat other diseases like Primary Immune Deficiency, but is not approved for AD treatment. Adults between the ages of 50 to 89 will take part in this study and they will be assigned to one of three treatment groups as follows: o Group 1: IGIV, 10% (200 mg/kg bodyweight) o Group 2: IGIV, 10% (400 mg/kg bodyweight) o Group 3: Placebo (0.25% human albumin) The study will take place across Asia Pacific, Europe, and North America. Approximately 402 people with mild to moderate Alzheimer??s disease will be treated with the study drug. This study is a ??double blind? study, which means that neither patients nor the study doctor or anyone directly involved in the study will know what treatment is administered, except for the pharmacist, who prepares the treatment. It is ??placebo controlled? which means patients may receive either a treatment drug (IGIV, 10%) or no active ingredient (placebo). Patients are to remain on their stabilised standard AD medication throughout their study participation.

• REC name

  HSC REC A

• REC reference

  12/NI/0146

• Date of REC Opinion

  14 Nov 2012

• REC opinion

  Further Information Favourable Opinion