Ok, I know that sounds pretty weird so let me explain.
I’m sitting at my desk where I’ve hovered for the last 3 hours waiting for something to be sent by email that I left at my office yesterday.
In case you’ve been following, it’s the final edit of my book “Please Don’t Die” on suicide prevention.
For the last 2-3 months I’ve been driven nuts trying to comply with the horrible software and customer support at Createspace, a self publishing Amazon owned site I used with no issues 5 years ago, when I published my first book and knew I wanted to write “please don’t die”. So I’m pretty decent at technology but this was unreal. I can’t tell you how many times I’ve been told in the last few months “I’m not allowed to help you with this” by people who are referred to as customer support. (100 is not an exaggeration).
So finally after finishing it and downloading it yesterday, I’d worked 11 hours and figured I’d go home and order the prints. No, that didn’t happen. It so happens that Createspace closed yesterday and everything was essentially lost and I was told, could not be retrieved by the new company, with the same staff, and the same “support” people telling me they couldn’t help me, which has to be bullshit of course, so I asked to speak to a supervisor. My answer was I would hear back from one in 24 hours.
So how can all this frustration and disappointment be a good thing? It is. Because my sister who isn’t a person who says nice things just to be nice, did her edits over 2 weeks and “loved it”. My final editor, Emily, told me it came to her at the perfect time. So how can I possibly be upset? My book already did what I wanted it to.
I hope disappointment comes your way because I hope, like me, it’s the worst thing that happens to you this holiday season. There’s so many truly awful things people are dealing with. When you think about it, this little thing is really a nothing, and will soon be forgotten.
This fact, that this is the worst thing happening in my life right now, when put in perspective, means that I’m really really lucky. We almost always are disappointed with our expectations. If you can lose those, and just accept what is today, that’s really the life blessing.
encouraging info below- meanwhile managing your stress level is your way to reduce issues with your brain function later. Keep physically active. Use your brain in challenging and novel ways regularly. I play soduku. Take Curcumin supplements-right now this is the only substance we know of that dissolves amyloid.
AN2401, a Promising Novel Treatment Against Alzheimer Disease
With the announcement of positive top line data from the phase 2 study of BAN2401, an anti-amyloid beta monoclonal antibody under investigation for the treatment of Alzheimer disease, Eisai and Biogen have begun planning an additional confirmatory open-label extension for subjects previously enrolled in Study 201, which is set to begin later this year. Topline results demonstrated a clinically meaningful difference in disease progression at the 10 mg/kg bi-weekly dose compared to placebo after an 18-month period.
To dive deeper into the results from Study 201 and discuss next steps for the investigational therapy, NeurologyLive spoke with Chad Swanson, PhD, Senior Director, Neurology Business Group, BAN2401 International Project Team Leader and Clinical Lead, BAN2401-G000-201 Study Director. Swanson explains that the data suggests that treatment with BAN2401 not only leads to a clinically meaningful difference on several clinical outcome measures when compared to placebo but that the rate of decline over 18 months is significantly slower in the intervention arm than placebo.
If BAN2401 does become FDA approved, treatment with the therapy could potentially slow the rate of disease progression and clinical decline for patients with early Alzheimer disease, which is tremendously impactful for not only patients but caregivers and families.
NeurologyLive: What are the results from Study 201?
Chad Swanson, PhD: The topline results of Study 201 demonstrated a clinically meaningful 30% difference in disease progression at the 10 mg/kg biweekly dose of BAN2401 compared to placebo at 18 months, which was found on the clinical efficacy measure of Alzheimer’s Disease Composite Score (ADCOMS) which we developed to detect changes in cognition and function on items that are most impacted early in Alzheimer disease.
This dose of 10 mg/kg biweekly of BAN2401 began to show its clinical benefits on ADCOMS as early as 6 months, and that effect was sustained over the entire duration of 18 months of treatment. Results for this dose on other endpoints including Alzheimer’s Disease Assessment Scale-Cog (ADAS-Cog) and Clinical Dementia Rating Scale (CDR) Sum of Boxes (CDR-SB) were also meaningful at 47% and 26% less decline at 18 months versus placebo, respectively.
Biomarker analyses that were conducted, which included change from baseline and amyloid positron emission tomography (PET) standard uptake value ratio (SUVR) (PETSUVR) showed a 70 unit reduction on the Centiloid scale and a conversion rate of 81% for amyloid positive to amyloid negative on amyloid PET visual reads, again at this top dose of 10 mg/kg biweekly.
We’ve seen some results on cerebrospinal fluid (CSF) biomarkers of neurodegeneration, such as neurogranin, phosphor-tau, and neurofilament light chain, all showing trends that are suggestive of BAN2401 having an impact on the underlying pathophysiology of Alzheimer disease. We pooled the top 2 doses of 10 mg/kg biweekly and 10 mg/kg monthly, in this case, and compared them to placebo at 18 months, and just by way of note, the ends for those biomarker results were 16 in the placebo arm and 23 in the pooled BAN2401 group.
Finally, BAN2401 had demonstrated an acceptable safety profile through 18 months of study drug administration, with incidents of amyloid-related imaging abnormalities of the edema type, or otherwise known as ARIA-E, which are the main safety observations in Study-201, were less than 10% across any of the treatment arms and less than 15% in equally positive subjects at the highest dose tested of 10 mg/kg biweekly.
What’s the next step?
CS: We’ve initiated active planning on an additional confirmatory study with authorities and we’re also happy to announce that we are running an open-label extension for the subjects who previously enrolled in Study 201, which will begin later this year.
Data we presented thus far suggests that treatment with BAN2401 not only leads to a clinically meaningful difference on a number of clinical outcome measures at 18 months when compared to placebo at this top dose of 10 mg/kg biweekly but also that the rate of decline over 18 months is significantly slower in the treated group compared to that of placebo. This suggests that perhaps if approved, that treatment with BAN2401 could potentially slow the rate of disease progression and clinical decline for patients with early Alzheimer disease. We believe that this overall slowing in the rate of disease progression would be the most impactful for patients with early Alzheimer disease, as well as caregivers and families.
Eisai has a very rich history of innovation in the Alzheimer disease space. We’re very encouraged by the totality of the Study 201 data, we’ve shown clearance of brain amyloid, we’ve seen trends in CSF biomarkers suggestive of effecting underlying Alzheimer disease pathophysiology, and we’ve seen an impact on the rate of disease progression for key clinical endpoints and clearly we’ve learned a tremendous amount about the potential for BAN2401 in this early Alzheimer disease population over the last few months and we certainly look forward to communicating next steps for the program as soon as our discussions with regulators have concluded.
Last week was a very very bad week for me. So much so that it feels like it didn’t even happen. So in my mind Thanksgiving is 2 weeks away – not one week away like it seems stuck in my head. So I will have from 20-30 people and have done zilch so far. But no, I’m not worried. I dealt with that sometime ago when I decided to “embrace the chaos”.
So it was soooo bad I thought I was having a nervous breakdown because I really couldn’t function. Everyone close to me who could see- my hubby and sister- were pretty concerned. And then I was like “what the f- brain?” and I finally figured it out.
So I take alot of supplements, like alot! It helps me stay well, I hardly even get a cold and when I do it’s super nothing like vague tiredness and a sneeze or two- so that batch takes up a whole drawer of my nightside table alone with my meds.
I usually never throw a bottle away until it’s replaced – but this time I went to the computer, ordered my branded antidepressant because the generic didn’t work for me and then spaced out…..
So I have no idea how long I was without my antidepressant. The day I figured it out was the day of my granddaughter’s 2nd birthday party and I was doing my darnest to try to focus on how happy I would be to see her and her little brother. It was a challenge and then ah hah! I checked my medication cassette and realized my mistake! I was so grateful to realize there was an explanation that I immediately felt better and took one of my generics and felt better in an hour – not well but much much better.
So, when my patients sheepishly think I will yell at them because they forgot or stopped their meds- I don’t and won’t. We all make mistakes. My husband and sister both say they will ask me next time they see me that “crazy”. For a week, I did whatever I needed to and went to bed, I slept hours and hours and could hardly function. It was incredibly painful, but especially frightening.
So, who cares about the turkey. I have so much to be grateful for. I’m so grateful for this little pill that helps me live my life and feel good much of the time. What a freakin miracle! I’m so grateful I’m alive in this time when such a little miracle is available to me.
And when patients tell me about hating their medication? Not wanting to be on one? Well, that’s their choice. Me, I am no fan of suffering. F- ck suffering people! This life is hard enough! No one gives you a purple star for being a hero and suffering! It’s your own f-in choice and nobody else’s business but the ones you trust. Find the meds that work for you! And if your own prescriber won’t help you, find someone who will.
So I was too optimistic thinking the finishing of the book meant that the book was finished. First I had to have my cover artist reformat it about 10 times, and then there were the internal format issues, convering the document to PDF, these things are not my forte, and it’s been on frustration after another. Each time I think it’s done, it’s not, and each time I have to resubmit everything and then wait 24 hours, how fun? Not.
Truthfully, had to find a couple live humans among the drones and if not for them, I might have shelved the whole shebang again. 30 calls, multiple hours on hold, 2 real human beings with a soul. Not bad.
So maybe december 1st. Just remember, if we expect things we’re always disappointed. That’s how life works. But if you go through it expecting nothing, wonderful surprises are there every day.
I’m putting it in writing for myself, my hubby and you all. This is the last book. Never again.
It was much easier years ago when there were live people helping, now it’s all computer software and you need to be a genius or professional at knowing the software.
Boy I’m tired.
yes, it finally happened
it feels kind of weird….to not have that burden anymore….
but I can’t figure out how to add the pic today so sorry!
In the Buddhist tradition, each life force is believed to be reincarnated in a form related to their life on earth
Given this, here are my predictions
Donald Trump will return as a mosquito. Granted he will be the biggest, ugliest, and most TREMENDOUS mosquito you’ve ever seen.
Mitch MicConnell will be a bottom dwelling eel.
Paul Ryan will be a spineless slug
Sarah Huckabee Sanders, Kellyanne Conway, and Sean spicer will be cockroaches
John McCain will be a Bhutan Glory butterfly, endangered and rare