GN39763 - MTAU9937A in patients with Alzheimer's Disease
Research type
Research Study
Full title
A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, EFFICACY, AND SAFETY STUDY OF MTAU9937A IN PATIENTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE
IRAS ID
234823
Contact name
Catherine Mummery
Contact email
Sponsor organisation
Genentech Inc
Eudract number
2017-001800-31
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
4 years, months, days
Research summary
The purpose of this study is to determine if MTAU9937A has the potential to delay the changes in the brain associated with the development of Alzheimer’s disease. The study will compare the effects, positive or negative, of MTAU9937A versus placebo (an inactive substance that looks like MTAU9937A and is given in the same way but contains no active drug).
This is a Phase II, randomised, double-blind, placebo-controlled, parallel-group study. The study is designed to evaluate the effectiveness, safety and how well tolerated MTAU9937A, the study drug, is when taken by participants with prodomal Alzheimer’s Disease (pAD) and mild Alzheimer’s Disease (mAD). The study will also look at how well the body processes MTAU997A.
The study treatment is defined as the study drug plus the radiolabelled contrast substance which is administered during PET imaging procedures which are used on this study, to determine the levels of the tau protein.
The study consists of a screening period where a potential participant goes through a series of tests and assessments to determine whether they are eligible to enter the trial, a double-blind treatment period where the participant is given either the active drug or placebo, post-treatment follow up visit where a participant will be asked to attend a safety follow-up visit and undergo number of tests and assessments, an optional open-label extension (OLE) period where the participant is given the opportunity to continue in the study knowing they will be given the active medication following the completion of the research study.
Participants will be randomly assigned to one of three active, Intravenous (IV) dose arms (1500 mg, 4500 mg, or 8100 mg MTAU9937A) or to an IV placebo dose arm in a 2:3:2:3(1500 mg:4500 mg: 8100 mg:placebo) ratio.
REC name
London - Chelsea Research Ethics Committee
REC reference
18/LO/1176
Date of REC Opinion
17 Aug 2018
REC opinion
Further Information Favourable Opinion