Open Label Extension Study – for subjects completing M10-985

• Research type

  Research Study

• Full title

  Long-Term Safety and Tolerability of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease: An Open-Label Extension Study for Subjects Completing Study M10-985

• IRAS ID

  103976

• Contact name

  Craig W Ritchie

• Sponsor organisation

  Abb Vie Deutschland GmbH & Co KG

• Eudract number

  2011-004780-75

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study will look at how safe and how well tolerated, a test compound, ABT-126, is when given for an additional 28 weeks, for the treatment of Alzheimer??s disease (AD). Patients diagnosed with mild to moderate AD, who have completed the M10-985 study and who have a primary caregiver (family, friend or someone who knows them well), may be able to take part in the study. 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 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. All patients will receive ABT-126, Patients will be treated for 28 weeks and regularly see the study doctor. There will be a 30 day follow up call after the end of the treatment to check how the patient is doing.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  12/SC/0312

• Date of REC Opinion

  22 Jun 2012

• REC opinion

  Favourable Opinion