Novartis, Amgen and Banner Alzheimer's Institute remain committed after discontinuation of two Generation Program studies

11 July 2019 – Novartis, Amgen and Banner Alzheimer's Institute have announced the discontinuation of investigation of the BACE1 inhibitor CNP520 (umibecestat) in two Phase II/III studies. The decision followed the identification of worsening in some measures of cognitive function during a regular pre-planned review of unblinded data; the sponsors concluded that the potential benefit for participants in the studies did not outweigh the risk.

Dr. John Tsai, Head of Global Drug Development and Chief Medical Officer, said:

"Novartis has a strong research focus and commitment to patients. As researchers we have to accept today's disappointing news as part of the search for innovative new treatments. We remain committed to advancing science in Alzheimer's disease and continue to seek future solutions for people with neurodegenerative conditions." 

Alzheimer’s disease is the most common form of dementia, the collective term for a range of degenerative neurological conditions that affect memory, thinking, behaviour and emotion. There is no cure for dementia and has been no new treatment for the symptoms of dementia since 2002.

ADI is reassured that Novartis, Amgen, and Banner Alzheimer’s Institute remain committed to the field and will continue with other research into treatment for early assets of Alzheimer’s disease and other neurological conditions. They also plan to further assess and share the data.

Dr. Tsai went further to say:

"Beyond presenting our analyses, we will go a step further and will also share our data with the scientific community, not only to contribute to the increasing body of knowledge in Alzheimer's research but to add value to ongoing discussions with governments, multilateral organizations, patient groups, pharmaceutical companies, and society, to ensure that we collectively address the public health challenges presented by this disease."

Paola Barbarino, Chief Executive Officer of ADI, said:

“We are disappointed to hear that the Generation Programme trials have ended prematurely. However, we will continue to take learnings from the data and do everything we can to support those affected by dementia around the world.”

More investment is needed to support research on dementia across all key areas: basic science, care improvements, prevention and risk reduction, drug development and public health. Read more in the World Alzheimer Report 2018 and join our Global webinars on research participation.

ADI has 100 members associations globally, which provide advice and support to people living with dementia and their care partners. If you would like to contact your local Alzheimer Association, please visit our website.