Takeda TOMM40_301 Alzheimer's Disease study

• Research type

  Research Study

• Full title

  A Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Simultaneously Qualify a Biomarker Algorithm for Prognosis of Risk of Developing Mild Cognitive Impairment due to Alzheimer’s Disease (MCI due to AD) and to Test the Safety and Efficacy of Pioglitazone (AD-4833 SR 0.8 mg QD) to Delay the Onset of MCI due to AD in Cognitively Normal Subjects

• IRAS ID

  131071

• Contact name

  Lefkos Middleton

• Contact email

  l.middleton@imperial.ac.uk

• Eudract number

  2012-003111-58

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  This research study is in the area of Alzheimer’s Disease and has two goals. The first goal is to see if it is possible to predict if a person will develop Mild Cognitive Impairment (MCI: a brain disorder where thinking abilities are mildly impaired) due to Alzheimer’s Disease based on his/her genes. The second goal is to test a study drug to see if it will delay the first symptoms of mild cognitive impairment due to Alzheimer’s Disease in people who are currently cognitively normal and thought to be at high risk for developing this condition (based on the results of a genetic blood test).
  Approximately 5800 people aged 65-83 with normal thinking, reasoning, and memory abilities will participate in this study at approximately 50 study centres in North America, Europe, Russia, and Australia, including 9 centres in the UK. Participants will need to have a genetic test in order to participate. Participants will also need to have a project partner who knows them well and is willing to attend clinic visits with them.
  Participants are expected to be in the study for up to 5 years and will have 2 phone calls and 2 clinic visits every year. Assessments will include blood tests, physical and neurological examinations and ECGs (a tracing of the electrical activity of the heart). MRI scans may also be required for some participants. The study doctor will conduct other tests and give participants questionnaires that assess their mental status, changes in memory, quality of life, use of healthcare resources, depression, and suicidal thoughts. If participants do develop mild cognitive impairment then they will be withdrawn from the study.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  13/SC/0332

• Date of REC Opinion

  20 Sep 2013

• REC opinion

  Further Information Favourable Opinion