I have been participating in the Generations 1 study, taking either CNP520 or a placebo daily since May. I just got this notification from the study team:
We regret to inform you that the sponsor, Novartis, has decided to terminate the Generations Study. As we have previously communicated to you, there were previous clinical trial(s) using BACE-Inhibitors (a similar type of drug) which showed decline in cognitive performance in the group of people taking the drug compared to the group taking placebo. These were not noticeable on the individual patient level. As a result, Novartis amended their study protocol by adding additional cognitive assessments to enable the earliest detection of changes in cognitive performance. Novartis has analyzed the data collected thus far and found that there were declines in cognitive performance in the group taking CNP520 compared to the group taking placebo. Novartis also found that individuals taking CNP520 had greater atrophy in the brain and greater weight loss.
I spoke to them later by phone. They said the CNP520 component was being shut down for both Generations 1 and 2, but were not sure about the status of the CAD106 component of Generations 1.
I too am in the Generations I trial and have been for 19 months. I too received word of the decision to end the trial this evening, although I have not yet had a chance to talk to my direct study contact at the site about details like follow-up appointments, whether we will find out which group we are in etc.
I assume that every effort was made to contact every participant (hundreds) today, and know that this had to be a very recent decision, since I was just at the study site 3 weeks ago and spoke with the doctor in charge and made appointments for September.
However, I also want to make it very clear that this is NOT the time for those who believe that this particular trial was a bad idea, or that Novartis and other drug companies are not interested in prevention, or that another failure is a good thing because it will make people seek lifestyle interventions to share those opinions. None of those responses would be appropriate to people enrolled in a failed cancer treatment trial, nor will they be helpful to those of us who have spent years giving blood, having MRIs and PET scans, taking cognitive tests, bringing our partners along to answer questions about our skills and behaviors, taking suicide ideation questionnaires. We all knew very clearly the risk not only of failure, but of personal harm to ourselves and signed multiple consents, so that we, and those younger than us, might have a chance of a prevention drug proven to work in ApoE 4.
Failure in science is not just a given; it is a necessity. The methodology of the Generations I and II trials, an experiment that was double-blinded, with a precise, well-controlled risk group, will allow for years of analysis. CNP520 may be gone; but the biomarkers of our blood, our MRIS, our PET scans and our tests may continue to help, since Novartis has promised to share their data. My own cognition has not changed, nor has my weight gone down. Whether that means I was on the placebo or the study drug is immaterial to me, since the experience allowed me to meet wonderful people (participants and study researchers) and learn just how difficult study design, approvals at each individual study site, recruitment, retention, and rigorous statistical analysis by outside evaluators are--and how important.
blp, I hope that you too feel that your effort and time was not wasted. Thank you for your service to the ApoE 4 community.