Efficacy and safety of GSK239512 in mild to moderate Alzheimer’s

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of the H3 receptor antagonist, GSK239512 in subjects with mild to moderate Alzheimer’s disease.

• IRAS ID

  27867

• Contact name

  Kim Mahood

• Sponsor organisation

  GlaxoSmithKline UK Ltd

• Eudract number

  2009-012614-48

• ISRCTN Number

  NA

• Research summary

  The purpose of this study is to test the safety and effectiveness of GSK239512 in patients with mild to moderate Alzheimer??s Disease (AD). AD is a form of dementia with loss of memory and other abilities occurring in middle age or later. GSK239512 is a histamine 3 (H3) antagonist which means that it blocks histamine in the brain. Histamine is a compound found in the body which is related to inflammation. There is some evidence to suggest that histamine is linked to AD. This study will compare GSK239512 and a placebo (dummy drug). One group will take placebo and the other group will take GSK239512 for a period of 16 weeks. In the early part of the study, patients will have a weekly dose increase in order to find the most safe and effective dose of the study medication. The effects of the drug both good and bad will be compared to effects seen in people who are not taking the drug. This study will be conducted in a small number of UK clinics. GSK239512 is currently not approved for doctors to prescribe to patients. A computer will put people into groups by chance. Neither the study doctor nor the patient will be able to choose the group. During the study, neither the patient nor the study doctor will know which group the participant's in. This way the findings and assessments from the two groups will be handled in the same way. Information about how the study affects the patient??s body and health will be collected through a number of tests and procedures e.g. blood tests and questionnaires. This study will last about 20 weeks. During this time the patients will need to have tests, visit the clinic on schedule and tell their doctor about any changes.

• REC name

  Scotland A REC

• REC reference

  09/MRE00/60

• Date of REC Opinion

  26 Oct 2009

• REC opinion

  Further Information Favourable Opinion