CAD106 and CNP520

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blp
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Re: CAD106 and CNP520

Postby blp » Thu Jul 11, 2019 7:38 pm

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.

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Re: CAD106 and CNP520

Postby NF52 » Thu Jul 11, 2019 8:43 pm

blp wrote: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.
Hi blp,

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.
4/4 and still an optimist!

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Re: CAD106 and CNP520

Postby blp » Thu Jul 11, 2019 10:16 pm

NF52 - Very much agree with what you said. I do not at all feel my time was wasted and am glad to have taken part even for the short time i was an active participant. My contact seemed to think we would be told at some point whether we were in the placebo or treatment group, but couldn't say for sure yet.

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Re: CAD106 and CNP520

Postby donbob » Fri Jul 12, 2019 4:34 am

blp wrote: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 am scheduled for Monday, July 15, for the PET scan results. I hope that will not be canceled. Guess I’ll find out today.
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Re: CAD106 and CNP520

Postby Julie G » Fri Jul 12, 2019 7:59 am

This one is particularly heartbreaking as it hits our community. Huge thanks to those who participated. Your service advanced the science. I pray none of our members were harmed.

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Re: CAD106 and CNP520

Postby NF52 » Fri Jul 12, 2019 8:15 am

donbob wrote:I am scheduled for Monday, July 15, for the PET scan results. I hope that will not be canceled. Guess I’ll find out today.
Hi donbob,
I'm guessing you have heard or will hear today. I just spoke with the Nurse Practitioner for my site and have been advised that all future PET/MRI scans will be cancelled, which would seem to include your Monday appt. She shared that all sites were notified last yesterday afternoon (Eastern time) and study staff were asked to stay late and do their best to contact all participants and make sure they stop taking the drug.

As far as they know, the effects seen were similar to those on other BACE1 trials, with a small, but significant difference seen on some (not all) of those taking CNP520 on cognitive scores at the 3 and 6 months post-baseline testing. No further decline appeared after that apparently. (No word on percentage affected yet.) This was only discovered at the most recent independent non-blinded evaluation of data in late June, so they are quickly acting on the information. , but that at least one more cognitive assessment will be done at the next scheduled time.

They are awaiting further details from the study organizers, but also expect that eventually, all participants will be notified of whether they were taking the placebo or CNP520.
Last edited by NF52 on Fri Jul 12, 2019 8:55 am, edited 1 time in total.
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Re: CAD106 and CNP520

Postby NF52 » Fri Jul 12, 2019 8:16 am

Julie G wrote:This one is particularly heartbreaking as it hits our community. Huge thanks to those who participated. Your service advanced the science. I pray none of our members were harmed.
Deep thanks for your empathy and support, Julie.
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Re: CAD106 and CNP520

Postby ru442 » Fri Jul 12, 2019 8:41 am

Julie G wrote:This one is particularly heartbreaking as it hits our community. Huge thanks to those who participated. Your service advanced the science. I pray none of our members were harmed.

Yes this is a bummer.... thanks to all for participating for us!
Male 4/4 55 yrs., "Live, Laugh, Love"

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Re: CAD106 and CNP520

Postby donbob » Fri Jul 12, 2019 9:25 am

NF52 wrote:
donbob wrote:I am scheduled for Monday, July 15, for the PET scan results. I hope that will not be canceled. Guess I’ll find out today.
Hi donbob,
I'm guessing you have heard or will hear today. I just spoke with the Nurse Practitioner for my site and have been advised that all future PET/MRI scans will be cancelled, which would seem to include your Monday appt. She shared that all sites were notified last yesterday afternoon (Eastern time) and study staff were asked to stay late and do their best to contact all participants and make sure they stop taking the drug.

As far as they know, the effects seen were similar to those on other BACE1 trials, with a small, but significant difference seen on some (not all) of those taking CNP520 on cognitive scores at the 3 and 6 months post-baseline testing. No further decline appeared after that apparently. (No word on percentage affected yet.) This was only discovered at the most recent independent non-blinded evaluation of data in late June, so they are quickly acting on the information. , but that at least one more cognitive assessment will be done at the next scheduled time.

They are awaiting further details from the study organizers, but also expect that eventually, all participants will be notified of whether they were taking the placebo or CNP520.

Thanks for the information. I have a call in to confirm my Monday Doctor appointment to discuss the results of the PET scan. Hope they get back to me. It is a 100 mile drive one way.
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Re: CAD106 and CNP520

Postby blp » Fri Jul 12, 2019 11:04 am

Here's a link to a press release from Novartis about discontinuing the clinical trial, dated yesterday (July 11):

https://www.novartis.com/news/media-releases/novartis-amgen-and-banner-alzheimers-institute-discontinue-clinical-program-bace-inhibitor-cnp520-alzheimers-prevention


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