Please login to the form below

Not currently logged in
Email:
Password:

Landmark study will test Genentech drug for Alzheimer's prevention

Roche unit will collaborate with the Banner Alzheimer's Institute and the National Institutes of Health to study crenezumab

Roche Basel Switzerland

A drug in development at Roche's Genentech unit is to be tested in a landmark study to see if it can prevent early-onset Alzheimer's in people who are genetically predisposed to develop the disease.

The five-year study is the first of its kind and will see if Genentech's crenezumab can actually prevent Alzheimer's disease from developing among the members of an extended family grouping in Colombia that carry the presenilin-1 (PSEN1) gene.

People with the PSEN1 mutation have a much greater tendency to produce amyloid beta, one of the constituents of the plaques that characterise Alzheimer's, and typically go on to develop the cognitive symptoms of Alzheimer's around the age of 45.

Genentech is collaborating with the Banner Alzheimer's Institute and the National Institutes of Health on the $100m Alzheimer's Prevention Initiative (API) study, which will last five years and enrol around 300 asymptomatic subjects who can be traced to a PSEN1-positive common ancestor. A small number of patients in the trial will be from the US.

"We will attempt in the study to prevent the build-up of plaques in the brains of patients, thereby hopefully preventing the cognitive decline that accompanies the disease," said Richard Scheller, executive vice president of research and early development at Genentech.

"This is the ultimate test of whether amyloid beta is the toxic substance that causes the disease; up to this point this is still a hypothesis that has not been proven," he added.

Crenezumab is thought to cross the blood brain barrier into the central nervous system, bind to amyloid beta and cause it to be removed from the brain via the cerebrospinal fluid before it can aggregate into plaques.

If effective in the PSEN1-posiitve population, the antibody could become a means of preventing symptom development among patients with other, more common forms of Alzheimer's, said Scheller.

The humanised monoclonal antibody - known as MABT5102A - is in two trials looking at its ability to affect the progression of symptoms in patients with mild-to-moderate Alzheimer's. Genentech licensed the drug from Swiss biopharma company AC Immune in 2006.

16th May 2012

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
CSafe Global

CSafe Global is the only global provider of a full line of cold chain solutions and is the world’s largest...

Latest intelligence

New from the PhRMA: Diversity in clinical trials principles summarised
In November 2020, PhRMA announced the first-ever, industry-wide principles on clinical trial diversity. The principles were approved by the PhRMA Boards of Directors and will take effect in April 2021....
New from the FDA: Diversity in clinical trials guidance summarised
In November 2020, the FDA released guidance to enable greater diversity in clinical trials through changes to eligibility criteria, enrolment practices, and trial designs....
5 steps to effective clinical trial branding
When recruiting patients for your clinical trial, you want the materials and information around it to be seen as reputable and professional. To make it clear what the clinical trial...

Infographics