A4 Study: Double Down on Alzheimer’s

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Jmac
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A4 Study: Double Down on Alzheimer’s

Postby Jmac » Wed Feb 19, 2020 4:59 am

When I clicked the link at the end of the article to see details it went to a dead-end page. Boston area story.

Half receive the antibody solanezumab, and the other half get a placebo...Researchers are now enrolling participants in AHEAD 3-45 trials. They are looking to test antibodies in even younger participants starting at age 50.

https://www.ksat.com/health/2020/02/19/a4-study-double-down-on-alzheimers/

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Re: A4 Study: Double Down on Alzheimer’s

Postby Julie G » Wed Feb 19, 2020 7:16 am

When I clicked the link at the end of the article to see details it went to a dead-end page.

Might imply something about the amyloid hypothesis? Instead of "doubling down," it might be time to look up and expand mainstream thinking on how to treat this multifactorial disease process.

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Re: A4 Study: Double Down on Alzheimer’s

Postby Jmac » Wed Feb 19, 2020 7:32 am

Julie G wrote:Might imply something about the amyloid hypothesis? Instead of "doubling down," it might be time to look up and expand mainstream thinking on how to treat this multifactorial disease process.


I have a variety of Google alerts set up on AD, dementia, studies, etc. I am amazed at how they keep going after the same "causes" and trying again and again for drugs to treat the same ol', same ol'. Sooner of later they'll catch up with us :-)

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Re: A4 Study: Double Down on Alzheimer’s

Postby NF52 » Wed Feb 19, 2020 12:29 pm

Jmac wrote:
Julie G wrote:Might imply something about the amyloid hypothesis? Instead of "doubling down," it might be time to look up and expand mainstream thinking on how to treat this multifactorial disease process.


I have a variety of Google alerts set up on AD, dementia, studies, etc. I am amazed at how they keep going after the same "causes" and trying again and again for drugs to treat the same ol', same ol'. Sooner of later they'll catch up with us :-)
Hi jmac,

Looks like the editor for the newsletter should go back for re-training to check links! Here's the correct link to the Alzheimer's Prevention Trial Webstudy for people ages 50 or older, and some bullet points of what it offers to participants: apt webstudy
    * Access to secure, personalized, web-based tools to assess and track your cognitive performance
    * Opportunity to participate in comprehensive evaluations at one of our nationwide clinical sites
    * Opportunity to participate in clinical trials to prevent Alzheimer’s disease

In addition to the link not working, the reporter also confusingly combined information about two failed DIAN trials for people with rare, dominantly-inherited mutations that lead to AD in the 40's or 50's, with the A4 trial of one of the same anti-amyloid drugs for people in their 60's and 70's who have elevated amyloid in what is considered "preclinical Alzheimer's disease" . The A4 Study has been following people since 2014 and will end in 2022. Unlike many other anti-amyloid drug trials, it has not been halted due to outside evaluators deciding it could not reach a statistically significant outcome.

I've met two A4 study participants who are still in high-level employment in their 60's and 70's. They don't plan to abandon this hypothesis yet. These are not people who are ignoring the holes in the roof. No one who prioritizes sleep, exercise, intermittent fasting, learning an instrument at age 70+ and social engagement is putting all their eggs in one basket.

As an explanation of why they persist: research shows that people with elevated amyloid beta show no functional or cognitive impairment at baseline, but their risk of accelerated progression to SCI and MCI over 6-10 years is statistically higher than similar people (including ApoE 4) without elevated levels. Some research suggests this is even more true for ApoE 4 carriers. No one antibiotic kills all bacteria; by analogy they hope to be part of finding the "antibiotic" that at least slows their risk of AD and shows what happens over time to people with elevated amyloid if they do everything else right with lifestyle and supplements (none of that precludes their participation). I support their decision completely, and think we all have to recognize their choice is as valid as our own decisions.

Here is a brief description of what participants in APT Webstudy can expect:
APT Webstudy participants take online memory tests every three months, which take about 20 minutes to complete.
To enroll, registration takes about 30 minutes. This first visit will also ask you to agree/consent to participate, and to complete both the Cognitive Function Index (CFI) survey and the Cogstate memory assessment.

If we notice any changes in your memory and thinking performance overtime, we may invite you to a clinic located closest to you for further evaluation. Based upon this, you may then be matched to an Alzheimer's prevention trial if you are eligible.

APT webstudy is part of a strategy by the NIH and NIA to accelerate and improve research into Alzheimer's and related dementias by improving recruitment and participant selections, carefully select studies and provide early, transparent and shared data. It is organized by the Alzheimer's Clinical Trials Consortium (ACTC) which includes academic research centers at the Mayo Clinic, Cleveland Clinic, Johns Hopkins, University of Kentucky, Univ. of Pennsylvania, Harvard. Georgetown and many others, It is led by USC- San Diego. It includes Brigham & Womens' Hospital/Harvard and Dr. Sperling, who lost a father and grandfather to AD and is quoted in the newsletter from Boston.

ACTC is not focused on only the amyloid hypothesis. Here is a current posting seeking proposals for Stage Ib-III trials on the ACTC website; amyloid is not the only target (emphasis added):
Anyone is eligible. Non-pharamacological interventions are encouraged. ACTC works in collaboration with proposers to develop the project idea and submit grant for funding. Project ideas can include Alzheimer's disease as well as other related disorders.
https://www.actcinfo.org/submit-a-proposal/

Full disclosure: I recently participated in a newly-formed Alzheimer's Research Participant Advisory Board composed of 10 people (and some of their spouses) who have participated in a variety of clinical trials, or been screened and declined to participate, or cared for someone with early-onset AD, late-onset AD or dominantly-inherited AD. Nothing is more humbling than to meet a 32 year old Marine officer who has a rare Jalisco mutation for dominantly-inherited AD. He has gone public to increase knowledge of this mutation. He spends precious (and dwindling) time away from his wife and 3 year old daughter to help UCLA recruit people in LA and in the jalisco province of Mexico to diagnose and eventually turn off the mutation that gave his father and many relatives EAOD at age 40. He is in a DIAN trial, possibly the anti-amyloid trial recently cancelled, His participation isn't just on one focus; it also allows scientists to measure multiple biomarkers, subtle cognitive changes, the psychological impact of learning you have a dominant gene for early AD--all of which accelerates research. Tellingly, the Marines are all in on giving him whatever time he needs for this effort, without asking him to prove it will work.

Let's be willing to assume that many efforts on many fronts may be needed to prevent, slow or even reverse AD and related dementias. Research results which are scrupulously designed, evaluated and published and presented at national and international conferences do guide decisions; they also require a level of patience that tests the souls of many of us.
4/4 and still an optimist!

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Re: A4 Study: Double Down on Alzheimer’s

Postby chrissyr » Wed Feb 19, 2020 3:27 pm

Thank you, I ended up enrolling!

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Re: A4 Study: Double Down on Alzheimer’s

Postby Julie G » Thu Feb 20, 2020 6:39 am

NF52, I nominate you to replace the writer and editor for this publication. :D Thank you for setting the record straight. The APT webstudy looks like a great fit for our population and it provides cognitive testing that we could use to track our own cognition.
Full disclosure: I recently participated in a newly-formed Alzheimer's Research Participant Advisory Board composed of 10 people (and some of their spouses) who have participated in a variety of clinical trials, or been screened and declined to participate, or cared for someone with early-onset AD, late-onset AD or dominantly-inherited AD.

I've also participated in a similar panel, and like you, was struck by the fact that diet and lifestyle strategies were encouraged alongside the pharmaceutical that was being tested. IMHO, anything less would be unethical.
As an explanation of why they persist: research shows that people with elevated amyloid beta show no functional or cognitive impairment at baseline, but their risk of accelerated progression to SCI and MCI over 6-10 years is statistically higher than similar people (including ApoE 4) without elevated levels. Some research suggests this is even more true for ApoE 4 carriers. No one antibiotic kills all bacteria; by analogy they hope to be part of finding the "antibiotic" that at least slows their risk of AD and shows what happens over time to people with elevated amyloid if they do everything else right with lifestyle and supplements (none of that precludes their participation). I support their decision completely, and think we all have to recognize their choice is as valid as our own decisions.

My comment above wasn't intended to criticize any of our brave members who've participated in these trials. To the contrary, you and others in our community, are shining examples are courage and have certainly participated in moving the science forward. On the other hand, I do think that the excessive focus on amyloid beta (along with the neglect of concurrently examining other strategies) is the result of groupthink from the Alzheimer's research community that has gravely deterred progress. Your quote above is VERY relevant for our community as E4 carriers tend to have higher level of amyloid beta. From research to date, however, I remain unconvinced that finding the right "antibiotic" for abeta will yield in actual substantive improvements in cognition. I suspect that we should be exploring root causes that lead to abeta aggregation ( such as insulin resistance, cerebral glucose deficiency, viral contributors, etc.) and instead re-focusing research attention on those upstream contributors. Thank you for representing your perspective. You make us better and are greatly appreciated. -xo


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