Anavex Positive OLE-Alzheimer 192 ugers data April 2025
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Fint Tasso1
Jeg håber at dine informationer er rigtige og valide, da det ser ud som der skrives i forhold til hvilke interesse man har i forhold til Anavex -- læs Short eller Investeret
Limer sidste nyt ind fra US om detektering af Alzheimers, vil jo passe glimrende i forhold til Anavex.
Limer hele teksten ind da jeg ikke kan lime Link ind uden at der kommer alt muligt skrammel med -- håber det går.
For en god ordens skyld har jeg investeret -- Kurs ca 9,2
Artikel:
Amazing' reduction in Alzheimer's risk verified by blood markers, study says
Sandee LaMotte, CNN
Tue, April 8, 2025, 2:00 AM GMT+2
9 min read
49A combined blood test for cognitive decline has a 90% accuracy rate in determining whether memory loss is due to Alzheimer's disease. Dr. Sanjay Gupta explains.
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Editor's note: CNN Chief Medical Correspondent Dr. Sanjay Gupta and writerSandee LaMotte are part of the study covered in this story and have written about their experiences.
When Penny Ashford's father was diagnosed with early-stage Alzheimer's disease at age 62, she knew the devastating brain disorder might one day steal her memory. In her late 50s, her free-floating anxiety turned to outright panic when she began struggling to find words.
"I couldn't tell a story. I couldn't get my words out," said Ashford, now 61. "I remember sitting at a dinner party one time, and I couldn't finish my thoughts. It was the most unbelievable moment.
"I came home and sobbed and told my husband, 'Something is wrong with me. I can't talk,'" she said. "I was petrified."
Penny Ashford's father Barry Murphy, 75, blows out his candles while granddaughters look on. - Courtesy Penny Ashford
Today, after a complete revamp of her lifestyle and overall health, Ashford's struggles with retrieving words have eased, while measures of amyloid and tau proteins and neuroinflammation - all hallmark signs of Alzheimer's - have fallen.
Ashford knows about these improvements because she's part of a unique study tracking her progress via key blood biomarkers now being used to help diagnose early dementia. Instead of relying on painful spinal taps and expensive brain scans, these blood tests are heralded as a new, less invasive and time-consuming way to determine risk and aid in an earlier diagnosis of Alzheimer's.
The preliminary data, presented Monday at the American Academy of Neurology annual meeting in San Diego, analyzed biomarkers on 54 participants in an ongoing preventive neurology study called the Biorepository Study for Neurodegenerative Diseases, or BioRAND.
"The field is primarily using various biomarkers to determine if you have dementia or not," said lead study author Dr. Kellyann Niotis, a preventive neurologist who researches risk reduction for Alzheimer's and Parkinson's diseases at the Institute for Neurodegenerative Diseases in Boca Raton, Florida.
"No one is really looking at the changes in these biomarkers as outcome measures, as a way of tracking progress in a person's journey to improve their brain," Niotis said. "We believe these biomarkers may show how the disease progression is being modified biologically by a person's actions."
Less invasive test for Alzheimer's risk
Alzheimer's blood tests are the key to widespread prevention of dementia, experts say. If people can be diagnosed in their doctor's office, they can more immediately move into preventive care and implement lifestyle changes designed to slow the progression of their disease.
The problem, said senior study author Dr. Richard Isaacson, is the variability in how well these new blood biomarker tests work to predict or track disease progression.
"There is a dirty little secret in the Alzheimer's blood testing community where so many testing platforms, biotech companies, and a flurry of new blood tests are released," Isaacson said, "but it's unclear which of these tests are most accurate to track progression and evaluate response to therapies to slow progression toward dementia."
More in HealthMen's Fitness
To address this gap, Isaacson's research team and collaborators at five sites across the United States and Canada set forth to evaluate and eventually cross-compare the clinical use of what the neurologist said he believes will one day become "the cholesterol test for the brain."
"In the not so far future, people in their 30s, 40s, 50s, 60s and beyond will get a baseline test to evaluate risk and help track progress over time - similar to how traditional cholesterol tests are used today," said Isaacson, founder of one of the first Alzheimer's prevention clinics in the United States.
"Our eventual goal is to offer a blood panel at cost to help democratize access and broaden the ability for people to receive care," he added.
What Alzheimer's blood tests currently measure
Measuring levels of both amyloid and tau is key to understanding and diagnosing Alzheimer's and other forms of dementia.This illustration depicts cells in an Alzheimer's affected brain. The brown areas depict beta-amyloid protein plaques. The blue areas represent tau proteins that accumulate and form tangles. - NIH/AP
Amyloid plaques play a key role in the development of Alzheimer's when small clusters gather at synapses in the brain and interfere with the nerve cells' ability to communicate. Such plaques are thought to trigger changes in tau proteins,which form into tangles in parts of the brain controlling memory.
Tau tangles are also implicated in other neurological diseases such as frontal lobe dementia, or FTD, and Lewy body dementia in which abnormal clumps of a protein called alpha-synuclein accumulate in the brain's neurons.
The biomarker plasma phosphorylated tau 217, or p-tau217 for short, is a top contender in the diagnosis of mild cognitive impairment and early-stage Alzheimer's disease. Its cousin, p-tau 181, is also a helpful indicator.
P-tau 217 is a "beautiful marker for Alzheimer's," Dr. Maria Carrillo, chief science officer of the Alzheimer's Association, told CNN in an earlier interview.
"You're not really measuring amyloid, but the test is telling you it's there, and that's been backed up with objective PET (positron emission tomography) scans that can see amyloid in the brain," Carrillo said. "... If you have elevated tau in your brain, however, then we know that's a sign of another type of dementia."
Another biomarker test is the amyloid 42/40 ratio scan, which measures two types of amyloid proteins, another key biomarker of Alzheimer's disease. At times, such tests work best when used together. In an earlier study, a combination of both amyloid and p-tau 217 tests, called the amyloid probability score, showed a 90% accuracy rate in determining whether memory loss is due to Alzheimer's disease.
Glial fibrillary acidic protein, or GFAP, and neurofilament light chain, or NfL, which indicate brain inflammation and degenerative decay, are also helpful in tracking the progression of Alzheimer's disease. Dozens more biomarkers are being tested in labs around the world.
Isaacson's team at the Institute for Neurodegenerative Diseases is studying more than 125 individual markers from a variety of commercial and research-based tests, some of which may soon be available in a clinical setting.
Why investigate so many? Because personalized medicine may demand it, Niotis said.
"Neurodegenerative diseases present so differently in different people," she said. "It may be we will need a very nuanced, individualized approach in clinical practice to monitor the effectiveness of what we're doing for a given patient."
Hard work pays off in reduced risk
The ongoing preventive neurology study called BioRAND reported on 71 participants, with biomarkers being analyzed on 54 people. The other 17 people served as the control group.
The group of 54 received a series of personalized lifestyle recommendations designed to improve their brain. Such interventions have been shown in past research to improve memory and thinking skills by five points on a cognitive test for people with mild cognitive impairment.
The recommendations include a focus on blood pressure control, diet, exercise, stress reduction, sleep hygiene and weight control as well as addressing metabolic, hormonal and nutrient imbalances. Medications, vitamins and supplements are tailored to each person's unique needs.
Similar to a 2019 study led by Isaacson and Niotis, people who fulfilled at least 60% of the lifestyle recommendations were considered high compliance, while those who implemented less than 60% were low compliance. Periodic blood tests tracked progress in various brain biomarkers.
The outcome? The more work people put into change, the better their brains. Just look at Penny Ashford.
"My blood work was terrible; my eating habits were terrible. I didn't exercise, so my muscle tone was really bad - I had no muscles in my bottom or on my thighs," Ashford said.
"I got the lecture of a lifetime," she said. "They told me, 'Your window is closing, your markers are so bad. Either you've got to do this, or you're done.'"
'A 10 out of 10' on diet and exercise
A lifelong sugar addict, Ashford stopped eating sweets.
"I used to think I had a chemical imbalance because I was such a crazy freak about sugar - I could polish off a whole bag of Oreos, no problem, and I love ice cream," Ashford said.
"I haven't had a dessert. I haven't had ice cream. I haven't had anything except fruit since a year ago March."By working hard to improve her lifestyle, Penny Ashford has greatly improved blood biomarkers that track brain health. - Ted Ashford
She began an intense exercise program of cardio and resistance training, along with yoga for stress reduction, and moved to a plant-based Mediterranean style of eating. Under a doctor's supervision, she added supplements and vitamins to boost energy and lower stress.
"She was a 10 out of 10 with her diet and exercise," Niotis said. "She lost around 30 pounds and gained lean muscle mass. It was amazing."
A year later, Ashford's blood biomarkers told a completely different story about her brain health. Her p-tau 217 dropped by 43% and her p-tau 181 by 75%.
"We also looked at GFAP and neurofilament light, the markers of neuroinflammation and neurodegeneration," Niotis said. "Penny's GFAP went down by 66% and her NfL went down by 84%.
"These are really impressive changes in these markers of neuronal health," she said. "And the best part about it is it really did track with her clinical symptoms. Her word retrieval problems improved, and she felt so much better."
'I'm so proud of myself'
Ashford wasn't the only top performer in the study. Blood biomarkers also significantly improved across the entire group given risk reduction advice, Isaacson said, even those who were not as committed as Ashford.
"I've lost count on how many people have shown blood markers of brain disease trend in the right direction, but every time it amazes me," he said. "For over 20 years, I was told that what is happening right in front of my eyes was impossible, but the patients' stories, clinical improvements and test results speak for themselves."
Much more work remains before blood testing for Alzheimer's becomes a routine part of clinical practice, Isaacson said.
"Our group has a saying, 'Promise not to overpromise.' By this we mean it's critical to be transparent about the current limitations of these tests, and the variability across different platforms," he said.
While science works out the kinks, Ashford counts herself lucky to be able to track changes in her biomarker numbers - a key motivator in her journey toward better brain health.
"It's huge, huge," she said. "I'm so proud of myself. And each success that I have empowers me to do more, keep going and not let up.
"I look back at my dad. He didn't have any of these options. I watched my dad deteriorate, and I thank God, I am so lucky. We are so lucky."I må selv oversætte !!!
Søren
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Lidt fra CNN
Noget om biomarker målinger.
https://edition.cnn.com/2025/04/07/health/alzheimer-risk-blood-biomarkers-wellness/index.html -
Slidene viser at Anavex selv er forsigtige i deres konklusion så seekingalpha artiklen bibringer ikke noget nyt; men "glemmer" en meget vigtig pointe som er de meget små bivirkninger over den meget lange periode.
Anavex skriver:
-There were no deaths related to the study drug
-No adverse effects on liver enzymes, vital signs, ECGs, or physical/neurological examination findings
Det er et meget vigtigt resultat ikke mindst i forhold til de meget alvorlig bivirkninger ved mapperne (Lecanemab og donanemab).Hvis dataene kunne bære det ville Anavex skrive "The data/trial SHOWS"; men i stedet skriver de "suggest (antyder)" i deres konklusion i slidene: "Suggests earlier oral blarcamesine treatment initiation may have continued long-term beneficial therapeutic effect".
Dvs. for nye studier skal der fokuseres på pts med milde/tidlige symptomer på Alzheimer.
En anden vigtig funktion af OLE er at det ville være uetisk at afbryde behandlingen, fordi hovedstudiet vist jo at behandlingen havde en effekt.
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Anavex - Godkendte ansøgninger af EMA i 2024.
I 2024 gennemgik EMA 127 lægemiddelansøgninger og anbefalede 114 af dem til godkendelse. (5 blev ikke anbefalet, og 8 trak deres ansøgning tilbage). Det er en godkendelsesprocent på 90 %.
Anavex kom officiel på ansøgningslisten den 27. december 2024.
Som tidligere nævnt udfærdiger de 2 rapportører, der har fulgt Anavex siden omkring marts 2024, en evalueringsrapport til CHMP/EMA og Anavex efter ca. 120 dage. (80 dags rapporten blev først indført 2022/2023 og synes at være uofficiel og til internt brug?)
Denne første vigtige officelle evalueringsrapport vil være en indikation på hvordan CHMP/EMA ser på en mulig markedsgodkendelse i sidste ende!
120 dage svarer til ca. den 26. april 2025.Aktiemarkedet og den normale prissætning af selskabers værdi, er pt blevet kortsluttet af U.S. administrationen.
Vi ved dog også, at normalen vil vende tilbage på et eller andet tidspunkt, som efter alle øvrige div. kriser.
For Anavex betyder alene hvordan myndighederne (EMA) ser på casen - og Anavex ville aldrig være kommet så langt i processen, hvis ikke EMA - også i kraft af mentorordningen med de 2 rapportører, havde en positiv tilgang ved accept af ansøgningen.
Vedr. ansøgningen til EMA, så har Anavex bekræftet, at de seneste OLE data også var inkluderet i ansøgning, som blev indsendt den 26. november 2024.
Alt andet er bare støj lige nu!Kalu - tror helt sikkert at Anavex formulering som “suggest” bare er et udtryk for ydmyghed ift. at man pt. er i en evauleringsfase af EMA.
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Suggest/indicate bruges næsten altid til at beskrive hypoteser i videnskabelige artikler. Studiet var jo ikke designet til at påvise den indikation. Selv meeeget lang anavex og har skrevet en del videnskabelige artikler så mit svar et ikke rette mod at tale negativt om anavex
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Anavex Super med dit arbejde og input kalu
Opfattede på ingen måde din udlægning som negativ kritik, men som en konstruktiv anskuelse af det du ser.
Synes bare Anavex tidligere har brugt ydmyge udtalelser for ikke at foregribe, hvordan EMA måtte opfatte data.
Synes dog at både forskellen i point og p-værdierne taler deres eget sprog.
Synes i øvrigt godt, at Anavex kunne have lagt en kurve ind fra den database, som viser forventet udvikling i Alzheimer patienter - mener Mayo eller Pior har sat denne kurve ind på OLE-kurverne, hvor man ser en meget stor positiv forskel på de grupper, der fik Blarcamesine og kurven fra Alzheimerdatabasen. -
.. ("mener Mayo eller Pior har sat denne kurve ind på OLE-kurverne, hvor man ser en meget stor positiv forskel på de grupper, der fik Blarcamesine og kurven fra Alzheimerdatabasen...")
Men er det brugbart, hvis begge grupper fik Blarcamesine? (Boersboe evt??)
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Armen fra alzheimersbasen vil ikke kunne bruges. Men det giver nok en god indikation.
OLE forsøget er dog informativt nok uden placebo-arm (ubehandlet). Forsøget viser, at det er en signifikant fordel at komme i tidlig behandling og at forblive i behandling.
OLE forsøget var dobbelt blinded, hvor hverken patienter eller behandler ved hvilken arm pts er i. Forsøget opfylder dermed et væsentligt fagligt kriterium for validitet.
Fra Needham konferencen lyder det som om, at partneren måske er fundet. Det gætter Mayomobile også på.
Næste skridt er ansøgning om godkendelse på flere markeder - måske Australien. FDA er næppe på plads endnu med deres nye vejledning on ansøgning om godkendelse af stoffer i tidlige alzheimers patienter.
En evt meddelelse om partner vil smadre shorterne - som sikkert får lukket lidt ned i dag.
Mayomobile gætter på, at vi ikke hører om partner før en godkendelse hos EMA.
Tror selv på, at vi hører om en partner tidligere. Det ville i min optik være dumt ikke at tage imod en mindre upfront fra en heldig partner inden evt. godkendelse.
PS
NBI stod i 4900 for et år siden. I dag 3600. Et fald der nærmer sig 30% ! -
Undskyld min uvidendehed, men hvad betyder NBI
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Se her her Kontorchef.Linket finder du altid oppe i vores værktøjslinje under marked.
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Hmm forfatteren har en anden opfattelse;
"As for the open-label [vs. DB, randomized, placebo-controlled] trial, those who chose to remain in the ATTENTION-AD trial knew that everyone would receive blarcamesine, as there's no longer a placebo group. (See below)."
https://seekingalpha.com/article/4773574-anavex-understanding-their-alzheimers-open-label-extension-data-skeptically -
Se Boersboe´s seneste kommentarer og efterfølgende snak med Solsen i den anledning:
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Shorts øget pr 28/3 https://stocktwits.com/J60611/message/611131326
Missling skulle have udtalt, at man vil gå til fda og søge om accelerated approval https://stocktwits.com/Blarcamesine/message/611103795
New Drug for Early AD Shown to be Efficacious Safe
Trial participants exhibited improvements in cognitive function and activities of daily living, noted a D. Boral Capital report.
(www.streetwisereports.com)
Cirkus Trump kapitulerede. Svækker tilliden til deres evner.
Shorterne sveder i dag.
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Anavex Første gang vi har hørt, at Anavex muligvis påtænker at forsøge acc. proces i U.S.
H.C. Wainwright nævner også at dialog med FDA allerede pågår.
Tænker Missling burde have nævnt dette ved sidste præsentation, hvis det er tilfældet
Ellers ser analytikeren meget positiv på udviklingen i casen. - igen modsat SA artiklen!Raghuram Selvaraju, Ph.D er en af de 2-3 faste analytiker, der følger Anavex - fra tidligere ved vi også, at han også før har talt direkte med Missling udover ved selve præsentationerne.
Four-Year Data on New Drug for Early AD Positive
Long-term treatment with this small molecule seems feasible given its safety and tolerability profile, noted an H.C. Wainwright & Co. report.
(www.streetwisereports.com)
"European Approval First
Selvaraju reported that Anavex is looking to get blarcamesine approved for early Alzheimer's disease in Europe, first. A decision on the Marketing Authorization Application could be made before year-end, purported the analyst. If approved, the drug could be launched commercially late in 2026 in multiple countries there. Nearly 8 million people have Alzheimer's disease in Europe, and according to the European Brain Council, this number is expected to double by 2030."From our vantage point, therefore, the European market opportunity could be highly lucrative," Selvaraju commented.
Once and if blarcamesine is greenlighted in Europe, Anavex may pursue approval in the United Kingdom, Canada and Australia as well. The biopharma is having ongoing discussions about the same in the U.S., with the Food and Drug Administration.
"A favorable European regulatory decision could have meaningful impact upon the willingness of regulators in other territories to approve the drug," added the analyst."
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Anavex Mayos opdatering på OLE forsøget.
https://www.sotcanalytics.com/update-compendium-2025
" Conclusion
Patients in Anavex's Phase 2b/3 study began treatment at an approximate age of 74. According to a Johns Hopkins report from last year, average U.S. life expectancy is 75.9 years for men and 81.3 for women, with European averages slightly higher. Based on this data, if real-world outcomes mirror our projections, it is highly likely that patients who begin Blarcamesine treatment in very early-stage Alzheimer's or MCI may never progress to late-stage Alzheimer's. Instead, they could spend the remainder of their lives in early-stage Alzheimer's or an uncharacteristically slowly progressing moderate-stage. Given Blarcamesine's mechanism of action in targeting very early pathology, we believe that combining the drug with lifestyle interventions during preclinical stages could halt cognitive decline entirely.
To finalize, our previous analysis was a good peer-to-peer comparison, but this analysis opens the window to what Blarcamesine therapy could look like in the real world with full spectrum, real world conditions. Our placebo arm at week-192 is in line with academic generalizations of 8-12 point annual ADAS-COG13 declines."Her sammenligner og fremskriver han placebo patienter fra i alt 6 andre tilsvarende forsøg - i alt 2885 pts, herunder fra LLYs U.S. godkendte Donemab på en ADAS Cog13 skala.
Her ser man bl.a at selv for den mindst acc. sammenlignelige gruppe og de OLE pts der fik Blarcamesine fra starten, en bedre score på 14,875 og hele 21,211 point ift. gennemsnittet af alle 2885 pts.
Som Mayo skriver skal talene tages med forbehold, da der sker en fremskrivning til de 192 uger.
Forskellen er dog stadig så markant, iflg. Mayo, på både forskellen og sandsynligheden for at en tidligere medicinering med Blarcamesine, ville kunne bremse eller måske endda stoppe udviklingen af Alzheimer!Så selvom Anavex ikke selv havde en sammenlignelig placebo gruppe i deres forsøg, er det næstbedste en sammenligning med en placebo gruppe fra tilsvarende forsøg.
Tror også bl.a EMA muligvis ville skelne til sådanne markante resultater - især når bivirkningsprofilen på Blarcamesine er så positiv .
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