Eli Lilly just released Phase III results for their Alzheimer's immunotherapy Donanemab right after Leqembi received traditional approval. How do the two compare?
Well that's why you pass it onto the taxpayers! It was argued that Medicare may cover the costs if Leqembi received traditional approval, and so I wouldn't be surprised if there were some bureaucratic reasons for the approval. It would at least make sense given the very poor clinical data.
Check the excellent visual abstract below showing the effect of donanemab which is in line to get FDA approval later this year after lecanemab recent approval.
Now you know the limited efficacy and potential risks associated with anti-amyloid antibodies. On the other hand, the advantages of probiotics Bifidobacterium breve appear significantly more promising. Our recent randomized placebo-controlled double-blind clinical trials have yielded noteworthy results:
The daily consumption of Bifidobacterium breve has proven to be more effective in enhancing cognition and preventing 100% brain atrophy in subjects with Mild Cognitive Impairment (MCI).
Effect of Probiotic Bifidobacterium breve in Improving Cognitive Function and Preventing Brain Atrophy in Older Patients with Suspected Mild Cognitive Impairment: Results of a 24-Week Randomized, Double-Blind, Placebo-Controlled Trial
Probiotic Bifidobacterium breve in Improving Cognitive Functions of Older Adults with Suspected Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled Trial
Thanks for the links! I haven't looked through them in their entirety but I'd like to see more data on these trials. Unfortunately, they don't seem to be too compelling, at least as of this moment. There's a lot of factors to consider here, including that several of the patients did not show improvement on certain cognitive tests for the Asaoka, et al. trial. I'd have to look deeper into the inclusion criteria for these studies as well.
Asaoka, et al. included people with mild cognitive impairments by way of the CDR score being 0.5. Remember that the CDR scores for Leqembi and Donanemab were around 3-4, so it's a far different group being looked at. Xiao, et al. mentions that people diagnosed with dementia were excluded, but they don't state the degree of cognitive decline.
I haven't read into NMSE too deeply, but supposedly a score between 25-30 is considered normal cognition with 21-24 being mild dementia. Patients in both of these trials had average NMSE scores around 24.5, so it's barely at the cutoff.
I do believe there's likely to be a strong relationship between the gut and brain, and so the gut is likely to be a good place to consider by way of probiotics. However, I think I'd like to see more data than these two studies. The groups are far more mild in their cognitive decline, and so it's more of an apples to orange comparison between these people and the ones in the immunotherapy trials.
Become a permanent patient?
If I could afford it, and I can't, I would still pass.
Well that's why you pass it onto the taxpayers! It was argued that Medicare may cover the costs if Leqembi received traditional approval, and so I wouldn't be surprised if there were some bureaucratic reasons for the approval. It would at least make sense given the very poor clinical data.
Aʟᴢʜᴇɪᴍᴇʀ Exᴘᴇʀᴛ & Bʀᴀɪɴ Mɪᴄʀᴏʙɪᴏᴍᴇ Exᴘᴇʀᴛ
Frank Bernier, PhD, MSc, CIP
https://www.linkedin.com/posts/francois-bernier-phd_donanemab-visual-guide-to-the-phase-3-trial-activity-7086842390757408768-vebM
The Emperor has no clothes, isn't it?
Check the excellent visual abstract below showing the effect of donanemab which is in line to get FDA approval later this year after lecanemab recent approval.
Now you know the limited efficacy and potential risks associated with anti-amyloid antibodies. On the other hand, the advantages of probiotics Bifidobacterium breve appear significantly more promising. Our recent randomized placebo-controlled double-blind clinical trials have yielded noteworthy results:
The daily consumption of Bifidobacterium breve has proven to be more effective in enhancing cognition and preventing 100% brain atrophy in subjects with Mild Cognitive Impairment (MCI).
Effect of Probiotic Bifidobacterium breve in Improving Cognitive Function and Preventing Brain Atrophy in Older Patients with Suspected Mild Cognitive Impairment: Results of a 24-Week Randomized, Double-Blind, Placebo-Controlled Trial
https://pubmed.ncbi.nlm.nih.gov/35570493/
1ST TRIAL
Probiotic Bifidobacterium breve in Improving Cognitive Functions of Older Adults with Suspected Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled Trial
https://pubmed.ncbi.nlm.nih.gov/32623402/
Thanks for the links! I haven't looked through them in their entirety but I'd like to see more data on these trials. Unfortunately, they don't seem to be too compelling, at least as of this moment. There's a lot of factors to consider here, including that several of the patients did not show improvement on certain cognitive tests for the Asaoka, et al. trial. I'd have to look deeper into the inclusion criteria for these studies as well.
Asaoka, et al. included people with mild cognitive impairments by way of the CDR score being 0.5. Remember that the CDR scores for Leqembi and Donanemab were around 3-4, so it's a far different group being looked at. Xiao, et al. mentions that people diagnosed with dementia were excluded, but they don't state the degree of cognitive decline.
I haven't read into NMSE too deeply, but supposedly a score between 25-30 is considered normal cognition with 21-24 being mild dementia. Patients in both of these trials had average NMSE scores around 24.5, so it's barely at the cutoff.
I do believe there's likely to be a strong relationship between the gut and brain, and so the gut is likely to be a good place to consider by way of probiotics. However, I think I'd like to see more data than these two studies. The groups are far more mild in their cognitive decline, and so it's more of an apples to orange comparison between these people and the ones in the immunotherapy trials.
I'll stick to removing Al as per Exley.
Hmmm.... I'd try Dr Bredesen's way first.... and then more alternatives like methylene blue, detox heavy metals etc..