Novartis, Amgen and the Banner Alzheimer’s Institute (BAI) have partnered for the new Alzheimer’s Prevention Initiative (API) Generation Study 2 trial.
The latest trial follows the launch of the Generation Study 1 and will determine whether the BACE1 inhibitor CNP520 can prevent or delay the onset of Alzheimer’s disease (AD) symptoms in a high-risk population.
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BACE1 enzyme plays a vital role in the production of Amyloid ß protein that accumulates in the brains of individuals with AD years before the start of clinical symptoms.
Novartis Drug Development global head and chief medical officer Vas Narasimhan said: “Expanding our collaboration with Banner Alzheimer’s Institute stands testament to our belief that preventing amyloid buildup is one of the most promising approaches to treating Alzheimer’s disease.
“If we determine that our BACE1 inhibitor can prevent or delay the onset of symptoms in healthy yet high-risk populations, this would represent a tremendous breakthrough for those that may face this debilitating disease.”
As part of the five-year Generation Study 2, enrolling of participants started in the US in August this year. The study will eventually include more than 180 sites in more than 20 countries worldwide.
About 2,000 cognitively healthy participants aged 60 to 75, who are at high risk of developing AD based on their age and those carrying either two copies of the apolipoprotein E (APOE) 4 gene or one copy of the gene with evidence of elevated brain amyloid, will be recruited for the study.
Recruitment will be carried out through multiple venues, including the Alzheimer’s Prevention Registry’s GeneMatch programme.
Led by BAI, the API conducts prevention trials in cognitively healthy people at increased genetic risk for AD.
