Here is more promising info on the progress of a new treatment for Alzheimer's.
https://mail.google.com/mail/u/0/#inbox ... cxkkdkzWJD
Fc
What is Aducanumab and Why Does It Matter?
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Re: What is Aducanumab and Why Does It Matter?
Here's a direct link:Fc1345linville wrote:Here is more promising info on the progress of a new treatment for Alzheimer's.
https://mail.google.com/mail/u/0/#inbox ... cxkkdkzWJD
Fc
https://www.beingpatient.com/aducanumab ... erimental/
ApoE 3/4 > Thanks in advance for any responses made to my posts.
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Re: What is Aducanumab and Why Does It Matter?
Thanks Circular!
Fc
Fc
Re: What is Aducanumab and Why Does It Matter?
Thanks for posting the link Fc1345linville. I wasn't going to take time to listen, but I haven't been following this story at all but knew I should know at least a little about it. Your post got me to fire up the video while making breakfast. I seems to be a good, easy-to-digest summary of where things stand. My guess is that if it's approved that might also supercharge efforts to establish effective blood tests to diagnose and monitor Alzhiemer's pathology without the expensive brain scans and invasive lumbar punctures.Fc1345linville wrote:Here is more promising info on the progress of a new treatment for Alzheimer's.
https://mail.google.com/mail/u/0/#inbox ... cxkkdkzWJD
Fc
ApoE 3/4 > Thanks in advance for any responses made to my posts.
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Re: What is Aducanumab and Why Does It Matter?
I have been a participant in an Alzheimer's clinical study for the past four years, and it included an initial PET scan. I knew from the beginning that I was not their patient, in that the results of tests would not be shared, but if they discovered something that required immediate medical care, I would be informed. In other words, the results of the PET scan were to be used for the study exclusively.
I am certain that I share this experience with many others on the forum, as it seems to be a standard policy. But if a) Aducanumab is approved by the FDA, and b) blood tests for AD are delayed, I plan to have a conversation with the study sponsor about releasing the PET scan results to my own Neurologist, to avoid the exorbitant cost of an uninsured scan.
Fc
I am certain that I share this experience with many others on the forum, as it seems to be a standard policy. But if a) Aducanumab is approved by the FDA, and b) blood tests for AD are delayed, I plan to have a conversation with the study sponsor about releasing the PET scan results to my own Neurologist, to avoid the exorbitant cost of an uninsured scan.
Fc
Re: What is Aducanumab and Why Does It Matter?
That sounds like a good plan, and maybe it's another good reason to get into a trial that involves a PET scan for those of us not in one yet. I'll watch to see how it goes for you … if they approve Aducanumab.Fc1345linville wrote:I have been a participant in an Alzheimer's clinical study for the past four years, and it included an initial PET scan. I knew from the beginning that I was not their patient, in that the results of tests would not be shared, but if they discovered something that required immediate medical care, I would be informed. In other words, the results of the PET scan were to be used for the study exclusively.
I am certain that I share this experience with many others on the forum, as it seems to be a standard policy. But if a) Aducanumab is approved by the FDA, and b) blood tests for AD are delayed, I plan to have a conversation with the study sponsor about releasing the PET scan results to my own Neurologist, to avoid the exorbitant cost of an uninsured scan.
Fc
ApoE 3/4 > Thanks in advance for any responses made to my posts.
Re: What is Aducanumab and Why Does It Matter?
Fc1345linville, thank you very much for posting this.
I am going to repost it to my aducan thread.
This is a very startling result.
How could aducan possibly not be approved given such an update?
I am going to repost it to my aducan thread.
This is a very startling result.
How could aducan possibly not be approved given such an update?
Re: What is Aducanumab and Why Does It Matter?
Hi Circ and FC!,circular wrote:That sounds like a good plan, and maybe it's another good reason to get into a trial that involves a PET scan for those of us not in one yet. I'll watch to see how it goes for you … if they approve Aducanumab.Fc1345linville wrote:I have been a participant in an Alzheimer's clinical study for the past four years, and it included an initial PET scan.... the results of the PET scan were to be used for the study exclusively...
But if a) Aducanumab is approved by the FDA, and b) blood tests for AD are delayed, I plan to have a conversation with the study sponsor about releasing the PET scan results to my own Neurologist, to avoid the exorbitant cost of an uninsured scan.
Fc
It seems likely that any approval of aducanumab will be paired with a lot of conditions. Those might include starting with the same patient population as the studies used for approval: those with MCI or mild AD. This could be confirmed by both clinical tests and PET scan or the recently approved Precivity blood test of amyloid beta. Here's an article about Precivity from February 2021 in Scientific American: https://www.scientificamerican.com/arti ... lood-test/
It's also likely that initially, use of aducanumab would require being affiliated with a center that can interpret MRIs in the first 6-12 months of infusion treatments to monitor for ARIA-E (Amyloid-related imaging abnormalities) which have been observed in the class of drugs that target amyloid in the brain, including aducanumab, BAN2401, solanezumab, etc. Here's the data for Aducanumab and ARIA-E in ApoE 4 carriers: https://www.fda.gov/media/143506/download.
ARIA-E Incidence: Studies 301 and 302 Placebo and Aducanumab
Patients with ARIA-E
PLACEBO ARM:
ApoE ε4 non-carriers 13/334 (3.9% of non-ApoE4)
ApoE 4 carriers 16/42 (2.2% of ApoE4)
STUDY DOSE of 10 mg/kg= 1029 Participants
ApoE ε4 carriers 290/674 (43.0% of ApoE4 carriers at 10 mg/kg dose)
ApoE 4 non-carriers. 72/355 (20.3% of non-ApoE 4 carriers @ 10 mg/kg dose)
IMHO, 43% is a significant risk for symptoms of headache, nausea, vision disturbances and brain fog that "generally" resolve within 12-16 weeks. I like the odds of BAN2401, with only 14% of ApoE 4 carriers having ARIA-E better, and have even higher hopes for ALZ-801, which is a pill and has no incidence of ARIA--but both require more trials. BAN2401 is being studied now in cognitively healthy people, Circ, complete with a PET scan! But the PET scan is about the last part of a 90-day screening process! They have participants go through an extensive consent for screening and cognitive, daily living, blood and MRI testing, along with interviews with a care partner, before the PET scan is done. Participants who enter the trial phase after screening can elect not to know their ApoE4 status but have to know their amyloid beta status. https://www.aheadstudy.org.
By the way, a blood test or PET scan can only identify biomarkers associated with Alzheimer's disease. In people with normal cognition having "just" amyloid beta is considered "preclinical Alzheimer's disease" without being able to predict if, or when someone will progress to MCI or AD.
Just like learning Apoe4 can be a jolt, researchers want to be sure people are prepared for the possible effects of learning you have amyloid beta in your brain. Here's a brief excerpt from a sensitively written article:
Disclosure of preclinical Alzheimer's disease biomarker results in research and clinical settings: Why, how, and what we still need to knowHowever, knowledge of APOE or Aβ PET scan results may result in short-term increased subjective and objective cognitive decline. For example, APOE ε4 carriers with knowledge of their APOE status rated their memory more poorly and performed worse on memory tests than ε4 carriers without such knowledge.18 Conversely, non-carriers with APOE knowledge rated their memory more positively than non-carriers without APOE knowledge. These results suggest that learning AD-related genetic information may impact subjective memory rating and performance on memory tests. Similarly, individuals who learned their Aβ PET results were elevated reported more frequent subjective memory complaints and concerns that these memory complaints were related to Aβ.19 Overall, these studies show that disclosure of APOE and Aβ PET scan results to cognitively unimpaired research participants can be done safely without immediate psychological harm; however, there may be increased risk of subjective cognitive complaints.
We healthy ApoE 4/4s are becoming the prized participants in clinical trials--and more and more researchers are beginning to think that drugs which are much more effective in ApoE 4 carriers, like aducanumab, are likely to be approved first--possible just for our use!
4/4 and still an optimist!
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Re: What is Aducanumab and Why Does It Matter?
Thanks, NF52, for all of that relevant info on the Aducan trial process. I am now certainly not holding my breath to be a trial participant, but I hope we continue to see progress.
FC
FC