Novartis and Amgen search for Alzheimer's prevention drug

Novartis and Amgen have expanded an existing collaboration with Arizona’s Banner Alzheimer’s Institute (BAI), and begun a major study investigating whether a BACE1 inhibitor drug can delay or prevent onset in high-risk patients without symptoms who carry certain genes.

The five-year Generation Study 2 trial will test CNP520 at 15mg or 50mg dose, and will involve over 180 sites in more than 20 countries and around 2,000 cognitively healthy participants, aged 60 to 75.

Participants are at high risk of developing Alzheimer’s because of their age and because they carry either two copies of the apolipoprotein E (APOE) 4 gene or one copy of the gene with evidence of elevated brain amyloid.

The Generation Study 1 only targeted those who carry two copies of the APOE4 gene, a major genetic risk factor for late-onset Alzheimer's disease, with two compounds, an active immunotherapy CAD106, and CNP520.

Eligible participants will be randomised to receive one of two doses of the investigational anti-amyloid compound CNP520 (15 mg or 50 mg), co-developed by Novartis and Amgen, or a placebo.

The Generation Study 2 began enrolling participants in August.

The API Generation Program is the first to incorporate both genetic testing and counselling in addition to amyloid disclosure education into the study screening process.

For both studies, prospective participants referred to the trial will be required to learn their APOE test results. Only those who learn they have one or two copies will be eligible to participate.

In Generation Study 2, testing will also determine the participant's amyloid status, which will be disclosed by qualified medical personnel. Genetic counselling will be provided in person or by phone.

The initiative began in 2011 and is championed by the non-profit BAI and supported by the US government’s National Institutes of Health to accelerate research into Alzheimer’s prevention in high-risk groups.

Eric Reiman, API co-director and BAI's executive director said: "We are excited about the opportunity to work with our Novartis and Amgen colleagues to further accelerate the evaluation of promising prevention therapies, so it may be possible to find ones that work for the widest range of people at risk for developing Alzheimer's."