Posted on 11/17/2021 7:59:58 AM PST by bitt
First human trial for intranasal vaccine for AD represents culmination of 20 years of research led at the Brigham
Brigham and Women’s Hospital is set to begin a clinical trial that will test the safety and efficacy of a new vaccine delivered nasally intended to prevent and slow the progression of Alzheimer’s disease (AD). The trial represents the culmination of nearly 20 years of research led by Howard L. Weiner, MD, co-director of the Ann Romney Center for Neurologic Diseases at the Brigham.
“The launch of the first human trial of a nasal vaccine for Alzheimer’s is a remarkable milestone,” said Weiner. “Over the last two decades, we’ve amassed preclinical evidence suggesting the potential of this nasal vaccine for AD. If clinical trials in humans show that the vaccine is safe and effective, this could represent a nontoxic treatment for people with Alzheimer’s, and it could also be given early to help prevent Alzheimer’s in people at risk.”
The vaccine uses the immune modulator Protollin, an investigational intranasal agent that stimulates the immune system. Protollin is composed of proteins derived from bacteria and has been used safely in humans as an adjuvant for other vaccines. Protollin is designed to activate white blood cells found in the lymph nodes on the sides and back of the neck to migrate to the brain and trigger clearance of beta amyloid plaques — one of the hallmarks of AD. I-Mab Biopharma (I-Mab) and Jiangsu Nhwa Pharmaceutical (NHWA) are responsible for the development, manufacturing and commercialization of Protollin.
“For 20 years, there has been growing evidence that the immune system plays a key role in eliminating beta amyloid. This vaccine harnesses a novel arm of the immune system to treat AD,” said Tanuja Chitnis, MD, professor of Neurology at the Brigham and principal investigator of the trial. “Research in this area has paved the way for us to pursue a whole new avenue for potentially treating not only AD, but also other neurodegenerative diseases.”
The clinical trial will be a single ascending dose (SAD) trial of 16 participants, all of whom will be enrolled from the Ann Romney Center. Trial participants will be between 60 and 85 years of age with early, symptomatic AD. Participants must be in good general health with no disease expected to interfere with the study and have had an amyloid-positive PET scan. Participants will receive two doses of the nasal vaccine one week apart.
“We are thrilled to see Protollin approved to advance into clinical trials after many years of pioneering work, and we are honored to contribute our expertise in the global effort to develop novel therapies for this devastating disease,” said Dr. Jingwu Zang, founder, chairman and director of I-Mab.
The phase I trial’s primary objective will be to determine the safety and tolerability of the nasal vaccine. The research team will also measure the effect of nasal Protollin on participants’ immune response, including its effects on white blood cells, by examining cell surface markers, gene profiles, and functional assays.
“The immune system plays a very important role in all neurologic diseases,” said Weiner. “And it’s exciting that after 20 years of preclinical work, we can finally take a key step forward toward clinical translation and conduct this landmark first human trial.”
Funding: This study is funded by I-Mab and NHWA.
Just FYI...all someone as to do at a major hospital *anywhere* in this country is to give enough $$$ and a wastebasket...a lounge...a department...or a wing can be named after him or her.
A case in point: the Dana Farber Cancer Institute is seen by many in medicine as being the finest cancer treatment (and research) center in the world. It started "life" as the Sidney Farber Cancer Institute,Dr Sidney Farber having been one its founding physicians. But then along came the Dana family,promising $$$ for a major expansion,and the rest is history.
Cacao powder is milled from unroasted beans so is more bitter and retains more nutrition. Cocoa powder is milled from roasted beans which reduces bitterness and nutrition.
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“Watching the slow progression of the disease made me realize it’s only quality that will keep me around and not quantity if I were to succumb to it.”
Totally agree. Wasting away is not living. It’s hell for you and everyone around you.
Over the past two years IMAB has gone from a low of 10 to the 60’s today.
Just added it to my watch list.
I’m not investing.
They’re ChiCom.
I watched the geriatric Dr’s go in and out of that room, the consulting fees, the visits, the amount of money being taken from them, everything they worked for being bled dry, the bills for shit I never even heard of from people we have no idea who they are.
I will not be dependent on someone, not like that when I won’t even know who that someone is even if it’s my wife or daughter.
Handing everything I worked for for my family over to people who most I believe genuinely do care, but still a for-profit money machine meant to bleed you dry.
I just won’t put my family through what I had to and I’ve told them that before I even married my wife 32 years ago, and again after I raised our 3 children to understand it too.
When are they going to classify aspirin as a vaccine?
I just took an ibuprofen vaccine for a headache.
Me too. I have it on both sides of my family. The last thing I want is to be a burden on the ones I love.
We suspect my mom has it but it has been hell trying to get her to the doctor to get diagnosed. She was getting very hostile, vicious when we suggested it but now she has gotten worse in the past two weeks and she realizes something is wrong and has agreed to go.
She thinks crowds of people are living in her house when it is just her and my dad, any food we put in front of her she thinks it’s fake food and won’t eat it, and she at times thinks her parents are alive when they are not. Just a bunch of problems that are really freaking us out. I pray to God it is not Alzheimers but I don’t know what else it could be
> If clinical trials in humans show that the vaccine is safe and effective, this could represent a nontoxic treatment for people with Alzheimer’s
There’s a former senator from Delaware whose handlers might be interested in this.
“Should one get alzheimers, one’s inclination would be to just deal with it. “
You don’t “just deal with it”.
It’s a horrific disease and a terrible way to go .
If a treatment can prevent it or control the symptoms that’s a huge advance forward .
If you understand what I mean, no explanation is necessary. If you require an explanation, no explanation will suffice.
My 83 year old mother has been suffering from “Trump derangement syndrome”. She gets extremely agitated and hostile whenever any Trump related news comes on. She’s also forgetful and grasps for words, much like Brandon. There is a history of Alzheimer’s in both sides of my family. Compounded by diabetes. I can tell that her mind is worse, when she doesn’t manage her blood sugar well.
Hallucinations can also be a sign of Parkinson’s. Does your mom have tremors?
She must be perpetually agitated then as the media brings Trump into almost all stories.
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