ABT-126 with Mild to Moderate Alzheimers subjects on AChEIs

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT 126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase InhibiClinical

• IRAS ID

  98174

• Contact name

  Craig W Ritchie

• Sponsor organisation

  Abb Vie Deutschland GmbH & Co KG

• Eudract number

  2011-004849-40

• 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 things they want to do and 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 currently taking a 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 continue taking their prescribed medication for AD but will also receive either ABT-126, 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 patients safety.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  12/SC/0120

• Date of REC Opinion

  24 Apr 2012

• REC opinion

  Further Information Favourable Opinion