AD-4833/TOMM40_303 Extension Alzheimer's Disease study
Research type
Research Study
Full title
A Blinded Long-term Extension Study to Evaluate the Safety and Efficacy of Pioglitazone (AD-4833 Sustained Release 0.8 mg Daily) to Slow the Progression of Cognitive Decline in Subjects Who Have Completed the AD-4833/TOMM40_301 Study With Diagnosis of Mild Cognitive Impairment Due to Alzheimer Disease
IRAS ID
164229
Contact name
Lefkos Middleton
Contact email
Sponsor organisation
Takeda Development Centre Europe Ltd.
Eudract number
2013-004984-30
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
The study has three goals. One of these goals is to see whether or not the study drug called pioglitazone (AD-4833) may reduce the change in cognitive (thinking, reasoning and memory) abilities of people who are diagnosed with mild cognitive impairment (MCI-a brain disorder where thinking abilities are mildly impaired) due to Alzheimer’s Disease (AD) within the next 2 years.
The second goal is to learn more about whether or not pioglitazone may delay a diagnosis of AD dementia in people who are diagnosed with MCI due to AD.
The last goal is to continue collecting information about the longer-term safety and how well elderly people tolerate AD-4833.
Only patients who completed the pivotal AD-4833/TOMM40_301 study with an adjudicated diagnosis of MCI due to AD without ongoing serious adverse events from study AD-4833/TOMM40_301 will be eligible to participate in this extension study.
This multi-centre trial will be conducted worldwide. Of the 222 potential patients, aged at least 65 from approximately 60 study centres in North America, Europe and Australia, including 15 centres in the UK, it is expected that approximately 149 patients will take part in this extension study.The treatment assignment from the main study will remain unchanged, which means that patients will continue to receive the same study medication they received during the AD-4833/TOMM40_301 study:
• Pioglitazone tablet
• Placebo (dummy inactive pill)– tablet that looks like the study drug but has no active ingredient.
Participant’s treatment assignment will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need).
All participants will be asked to take one tablet at the same time each day throughout the study.The overall time to participate in this study is a minimum of 2 years and a maximum of 7 years. Participants will make approximately 2 visits per year to the clinic, and will be contacted by telephone 3 months after each treatment visit for a follow-up assessment, and 2 weeks after the final visit.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/1488
Date of REC Opinion
20 Jan 2015
REC opinion
Further Information Favourable Opinion