ABT-126 versus placebo in mild-moderate Alzheimer's Disease
Research type
Research Study
Full title
A Randomised, Double-Blind, Placebo- and Active-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild-to-Moderate Alzheimer's Disease
IRAS ID
20335
Sponsor organisation
Abb Vie Deutschland GmBH & Co.KG
Eudract number
2009-011424-64
ISRCTN Number
NA
Clinicaltrials.gov Identifier
Research summary
This study will look at how effective and how safe a drug called 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 AD 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, memory and decreased ability to do 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 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 receive either ABT-126, donepezil (an approved drug to treat the symptoms of AD) or placebo (which has no active ingredient). Neither the subject nor the study doctor knows whether the subject is taking ABT-126, donepezil, or placebo. Patients will be treated for 12 weeks and will see the study doctor. There will be a visit 2 weeks after the end of treatment to check the patient??s safety.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
09/H0502/104
Date of REC Opinion
2 Oct 2009
REC opinion
Further Information Favourable Opinion