Phase 2 ABT-384 in mild to moderate AD

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-and-active-controlled, parallel group study to evaluate the efficacy and safety of ABT-384 in subjects with mild to moderate Alzheimer's Disease

• IRAS ID

  47169

• Contact name

  Craig W Ritchie

• Sponsor organisation

  Abbott Laboratories Ltd

• Eudract number

  2009 017801-12

• ISRCTN Number

  NA

• Research summary

  This study will look at how effective and safe a drug (ABT-384) is in the treatment of Alzheimer??s disease (AD). AD affects 24 million people worldwide. We are living longer, hence the number of people with Alzheimer??s disease is increasing rapidly with numbers expected to double over the next 20 years. AD affects people in different ways. Over time, people with AD have increased difficulty with thinking and memory that interferes with their ability to do the things they want to do and take care of themselves. ABT-384 is under development at Abbott for the treatment of AD. ABT-384 targets learning and memory functions in the brain. Taking ABT-384 may produce improvement in symptoms of patients with AD. ABT-384 was generally well tolerated in early clinical trials in healthy volunteers, including elderly adults in good health. Patients diagnosed with mild to moderate AD, aged between 55 and 90, who have a primary caregiver (family, friend or someone who knows the patient well) and are not currently taking any prescribed medication for AD, may be able to take part. Patients will attend regular study visits at a study centre. The effect of the treatments on AD will be checked by asking the patients to answer questions about how they are doing. Patient safety will also be checked throughout the study by doing blood tests, ECGs, physical and neurological examinations. Patients will attend 3 visits to check if they are suitable for the study. Patients will receive either ABT-384, donepezil (an approved drug to treat AD) or placebo (which has no active ingredient). Patients will be treated for 12 weeks. They will see the study doctor about every 2 weeks. There will be a visit about 3 weeks after the end of treatment to again check the patient??s safety.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  10/H0502/31

• Date of REC Opinion

  28 Apr 2010

• REC opinion

  Further Information Favourable Opinion