Dose-Ranging study with ABT-126 in subjects with mild to moderate AD.

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo- and Active-Controlled Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects with Mild to Moderate Alzheimer's Disease

• IRAS ID

  83541

• Contact name

  Craig W Ritchie

• Sponsor organisation

  AbbVie Ltd

• Eudract number

  2011-002004-32

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study will look at how effective and how safe a test compound, ABT-126, is in the treatment of Alzheimer??s disease (AD). It is relevant and important because AD affects 24 million people worldwide and, because we are all living longer, the number of people with Alzheimer??s disease is increasing rapidly. It is expected to double over the next 20 years. AD affects people in different ways. Over time, people with AD have increased difficulty with their thinking and memory and decreased ability to do the things they want to do and to take care of themselves. ABT-126 is currently being tested by Abbott for the treatment of AD. ABT-126 targets part of the brain involved in learning and memory. As a result, taking ABT-126 may improve symptoms in patients with AD and may have fewer side effects than drugs that are currently available for AD. Patients diagnosed with mild to moderate AD, aged between 55 and 90, who have a primary caregiver (family, friend or someone who knows them well) and are not currently taking any prescribed medication for AD, may be able to take part in the study. Patients will attend regular study visits. The effect of the treatments on AD will be checked by asking the patients to answers questions about how they are thinking and doing. Patient safety will also be checked 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-126, donepezil (an approved drug to treat AD) or placebo (which has no active ingredient). Patients will be treated for 24 weeks and regularly see the study doctor. There will be a visit 2 weeks after the end of the treatment to check the patient's safety.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  11/SC/0468

• Date of REC Opinion

  12 Dec 2011

• REC opinion

  Further Information Favourable Opinion