DIAN-TU-001: Ph. II/III Randomized,Double-blind,Placebo in Alzheimer's
Research type
Research Study
Full title
A Phase II/III Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of 2 Potential Disease Modifying Therapies in Individuals at Risk for and with Dominantly Inherited Alzheimer’s Disease
IRAS ID
131418
Contact name
Catherine Jane Mummery
Contact email
Sponsor organisation
Washington University in St. Louis
Eudract number
2013-000307-17
Duration of Study in the UK
2 years, 7 months, 11 days
Research summary
This is an international, multi-site, phase II/III randomised, double-blind, placebo-controlled study of 2 potential disease modifying therapies (Gantenerumab and Solanezumab) in subjects who are either known to have a mutation causing Alzheimer’s disease OR who do not know their gene status but are “at-risk” for an autosomal dominant Alzheimer’s disease (ADAD) mutation. The purpose of this is to test whether one or both of these study drugs prevent, delay, or reverse the changes in the brain that are associated with the development of disease symptoms in ADAD.
The study will last approximately 104 weeks and will involve approximately 210 people (worldwide) at risk of developing ADAD. These subjects will be between 15 years younger to 10 years older than the age of symptom onset in their affected parent AND who are either symptom free or have mild symptoms of dementia.
Subjects will be randomised 1:1 to either the gantenerumab or solanezumab arm of the study. Within each treatment arm, subjects who are mutation carriers will be randomised to active treatment or placebo at a 3:1 ratio. All mutation non-carriers will be randomised to placebo.
Within the gantenerumab arm, subjects will receive either gantenerumab or placebo via injection under the skin) every four weeks. Within the solanezumab arm, subjects will receive either solanezumab or placebo via
injection of the drug into the patient’s vein every four weeks.It is anticipated that there will be 10-15 sites in the USA with additional sites outside the USA and 1 site in the UK.
Adverse events and serious adverse events will be reported by the investigator to the study sponsor and to regulatory bodies as required. Unblinded data on safety-related endpoints and SAEs will be reviewed quarterly by the Data Safety Monitoring Board (DSMB). Amyloid related imaging abnormalities (ARIA), which include cerebral vasogenic oedema and micro-haemorrhages, are a safety endpoint. MRI scans will be analysed for ARIA changes at the Mayo clinic. A report of new ARIA changes in a subject will trigger a review by the Medical Director, Project Arm leader and site principal investigator.
All patients, including those who withdraw or discontinue from the study early, will be followed for collection of safety data for at least 30 days from the time of their last dose of study drug; any SAEs should be reported even if they occur after that time.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
13/SC/0535
Date of REC Opinion
8 Jan 2014
REC opinion
Further Information Favourable Opinion