APOLLOE4 Study: Are you or someone you know struggling with memory loss?

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APOLLOE4Study
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APOLLOE4 Study: Are you or someone you know struggling with memory loss?

Post by APOLLOE4Study »

Are you or someone you know struggling with memory loss? Are everyday tasks more difficult?

Learn more about the APOLLOE4 study and an investigational tablet designed to slow the progression
of Alzheimer’s disease.

If you have early symptoms of Alzheimer’s disease, you may qualify for the APOLLOE4 Study. The study
may be right for you if you’re struggling with memory loss and find everyday tasks more difficult.

You may be able to join the study if you are:
  • • Experiencing memory loss due to Alzheimer’s disease
    • The study doctor will be able to confirm if you have Alzheimer’s disease
    • Between 50 and 80 years of age
    • Positive for the APOE4/4 gene (genetic testing provided at no cost)
    • Accompanied by a caregiver or study partner willing to attend study visits and participate with
    you
There are other requirements to take part in the APOLLOE4 Study. The study team will discuss these
criteria with you.

If you qualify, you may receive at no cost:
  • • Access to study drug for 18 months that is designed to slow Alzheimer’s disease progression
    • Close care and monitoring from an Alzheimer’s disease specialist
    • Opportunity to help advance the treatment of Alzheimer’s disease
    • Reimbursement for study-related time and travel expenses
To learn more about the clinical research study and to see if you may qualify, please visit the study
website at: APOLLOE4 Study

Thank you,

The APOLLOE4 Study Team
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Re: APOLLOE4 Study: Are you or someone you know struggling with memory loss?

Post by Tincup »

Moderator note, this study is not endorsed by ApoE4,info. We have no opinion on it. Do your own research about the study if interested.
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Re: APOLLOE4 Study: Are you or someone you know struggling with memory loss?

Post by NF52 »

To provide our members with additional information that may be useful, here are some links about Alz-801, the study drug, which is a "prodrug" of tramiprosate. a subject of interest to many on the forum in the past. [And if anyone is interested in detailed info about any other current or upcoming studies--I'm agnostic about studies--just hoping to support people wanting to learn more about any study!]

Below is the complete description of APOLLOE4 from the NIH Clinical Trials website, with the most recent update of Oct. 6, 2021:
Clinicaltrials.gov: An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects (APOLLOE4)

There is no indication in the study description that it has any relationship or is sponsored by Apollo Health, although the name suggests that:
Sponsors and Collaborators
Alzheon Inc.
National Institute on Aging (NIA)
Here is the listed inclusion criteria; because many people may have subtle cognitive impairment which would be considered indicative of MCI (mild cognitive impairment), the study info notes that having a diagnosis of MCI is not necessary to be screened, if worsening memory is a concern.
Inclusion Criteria:
*Clinical diagnosis of MCI or Mild Dementia due to AD consistent with the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Criteria.
*Homozygous for the ε4 allele of the apolipoprotein E gene (APOE4/4).
*MMSE score at Screening of 22 to 30 (inclusive).
*CDR - Global score of 0.5 or 1 and CDR Memory Box Score of ≥ 0.5.
*RBANS delayed memory index score ≤ 85.
*Evidence of progressive memory loss over the last 12 months per investigator assessment
Below is is a description of the study protocol from Clinicaltrials.gove:
Detailed Description:
This is a multi-center, double-blind study that will evaluate 265 mg BID [2 times per day] of ALZ-801, an oral tablet, over 78 weeks as a treatment for subjects (50-80 years old) with Early AD who are homozygous for the ε4 allele of the apolipoprotein gene (APOE4 homozygous or APOE4/4). The primary efficacy outcome assessment is a measure of cognition (ADAS-cog 13). Additional measures of global and functional impairments will also be assessed. Imaging and soluble biomarkers of AD and neurodegeneration will be measured and a sub-study to evaluate cerebrospinal fluid (CSF) biomarkers is also included.
This is the clinicaltrials.gov description of what the participants will receive after being randomized (by a computer algorithm, not a person), with a 50/50 chance of being on ALZ-801 study drug. Note that they are titrating the drug by giving a placebo in the AM and the study drug in the PM for 2 weeks; this is similar to how other anti-amyloid drugs start with a smaller dose for a period of time before moving to the full dose, to reduce side effects:
Experimental: ALZ-801
ALZ-801 265 mg BID [2 times per day] tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.

Placebo Comparator: Placebo
Subjects in the placebo treatment arm will receive placebo tablets BID [2 times per day] ]throughout the study
Here are the study locations, which include US, Canada, France, Spain and the UK. Contacts and Locations

This is a link to a post from June 2021 by Senior Contributor
BrianR wrote:
on this study: Dosing Starts in Phase 3 Trial of ALZ-801 in Patients With APOE[4/4] Variant

And finally, this is a link to a post I did from August 2020 with a link to an article titled Aducanumab, gantenerumab, BAN2401, and ALZ-801: the first wave of amyloid-targeting drugs for Alzheimer’s disease with potential for near term approval. Note: The first 3 authors are from Alzheon; the last two are respected researchers from the University of Rochester and the Cleveland Clinic.
4 drugs which may get approval in 3-5 years
4/4 and still an optimist!
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Re: APOLLOE4 Study: Are you or someone you know struggling with memory loss?

Post by Julie G »

Hi all! As Tincup point out earlier in this thread, all of our study opportunities are announcements as opposed to endorsements. Please do your own research. That said, Sano Genetics asked me to update this research announcement; (see below.) If interested, please reach out to their trial screener here.
___
At least 50 million people worldwide are thought to be living with Alzheimer’s disease (the most common form of dementia). Although the biggest risk factor for Alzheimer’s is ageing, the disease is not a normal part of getting older and there are genetic factors at play in some cases.

The goal of this study is to help develop a potential new drug treatment for Alzheimer's disease (AD), which researchers think could be effective in treating AD in its early stages. The drug, ALZ-801, is being developed by Alzheon as a potential new treatment for slowing or stopping cognitive decline in some AD patients.

Eligible participants for the study will receive either the potential new treatment drug or a placebo. The study will also help researchers gather further information about the drug’s long-term safety.

Who can take part?
You, or the person you care for, must:

Be aged 50 to 80 years old
Have a clinical diagnosis of Alzheimer’s disease or mild cognitive impairment
Be willing to securely share DNA data
Be willing to have DNA data screened for the APOE4 homozygous genotype (NOTE: They are looking for homozygotes)
Be based in the United States or United Kingdom

Why take part?
If you qualify for and decide to join the APOLLOE4 study, you may receive at no cost:
Access to a study drug for 18 months that is designed to slow Alzheimer’s disease progression
Close care and monitoring from an Alzheimer’s disease specialist
Opportunity to help advance the treatment of Alzheimer’s disease
Reimbursement for study-related time and travel expenses

Safety and security

When you entrust your DNA Data and Personal Information to Sano Genetics, we commit to keeping them safe and secure. If you consent to participate, the Study Data will be stored by Sano Genetics on secure, encrypted, and wholly owned and secure servers (e.g. HIPAA compliant servers). Every part of Sano is built privacy-first and we use clear, transparent language to keep you informed
at every stage throughout the process.
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Re: APOLLOE4 Study: Are you or someone you know struggling with memory loss?

Post by Julie G »

Hi all. This phase of the APOLLOE4 study has concluded. The study organizers have asked me to let you know that this opportunity is no longer available. When/if they have further updates, we'll be happy to share them.
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Re: APOLLOE4 Study: Are you or someone you know struggling with memory loss?

Post by NF52 »

Julie G wrote: Wed Aug 10, 2022 9:13 am Hi all. This phase of the APOLLOE4 study has concluded. The study organizers have asked me to let you know that this opportunity is no longer available. When/if they have further updates, we'll be happy to share them.
Julie,
I think the study that is no longer accepting participants is the the Gene Therapy for APOE4 Homozygote of Alzheimer's Disease

The APOLLOE4 study is active in 96 locations currently, for people with these criteria:
* Clinical diagnosis of MCI or Mild Dementia due to AD consistent with the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Criteria.
*Homozygous for the ε4 allele of the apolipoprotein E gene (APOE4/4).
*MMSE score at Screening of 22 to 30 (inclusive).
*CDR - Global score of 0.5 or 1 and CDR Memory Box Score of ≥ 0.5.
*RBANS delayed memory index score ≤ 85.
*Evidence of progressive memory loss over the last 12 months per investigator assessmenthttps://clinicaltrials.gov/ct2/show/NCT04770220#contacts
An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects (APOLLOE4)
4/4 and still an optimist!
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Re: APOLLOE4 Study: Are you or someone you know struggling with memory loss?

Post by Julie G »

Julie,
I think the study that is no longer accepting participants is the the Gene Therapy for APOE4 Homozygote of Alzheimer's Disease...
Ah, thank you for the update. I received this note yesterday from my contact at Sano Genetics:
I hope you are well. I wanted to reach out today for two reasons. First, it looks like an individual from your community successfully pre-screened for the study last week. We are working on getting that individual connected with a site.

Second, the sponsor has asked us to remove all posts and links to the screener since they are wrapping up this phase of recruitment. Would it be possible to remove/archive the post and/or the links from the post on your site?
So, while the study may be ongoing, it looks like this phase of recruitment is wrapping up.
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Re: APOLLOE4 Study: Are you or someone you know struggling with memory loss?

Post by NF52 »

Julie G wrote: Thu Aug 11, 2022 2:32 pm Ah, thank you for the update. I received this note yesterday from my contact at Sano Genetics:
I hope you are well. I wanted to reach out today for two reasons. First, it looks like an individual from your community successfully pre-screened for the study last week. We are working on getting that individual connected with a site.

Second, the sponsor has asked us to remove all posts and links to the screener since they are wrapping up this phase of recruitment. Would it be possible to remove/archive the post and/or the links from the post on your site?
So, while the study may be ongoing, it looks like this phase of recruitment is wrapping up.
Hi Julie,
The comment from Sano Genetics, which is not developing ALZ-801, but may have been recruiting for their Phase 2 study, seems confusing.

This clinical trials.gov link to the Phase 2 trial of ALZ-801 with 84 people that started in 2021 is listed as "active, not recruiting' as of an update posted today: Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease

This Phase 3 trial, started in May 2021 to recruit 300 people is listed as "active/recruiting"
An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects (APOLLOE4)

Also still active is a website for the trial, with a prescreening questionnaire: APOLLOE4

Just this week, I received an email from the Alzheimer's Prevention Registry inviting me to consider screening for the trial as someone with ApoE 4/4 with a link to the website above, noting that they are partnering with the study organizers to support recruitment. I also know someone who is considering enrollment in a clinical trial through an academic research center who was offered this as an option very recently.

Any chance your contact was referring to Phase 2 study, just closed to recruitment. I'd hate our members to lose out on info about a trial exclusively seeking ApoE 4/4 individuals with MCI/mild AD.
4/4 and still an optimist!
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Re: APOLLOE4 Study: Are you or someone you know struggling with memory loss?

Post by Julie G »

Any chance your contact was referring to Phase 2 study, just closed to recruitment. I'd hate our members to lose out on info about a trial exclusively seeking ApoE 4/4 individuals with MCI/mild AD.
My contact at Sano Genetics specifically provided the link to this thread on our website and asked me to archive the thread. I don't believe there is an error, but I'm happy to connect you so you can direct your questions directly to her.
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Re: APOLLOE4 Study: Are you or someone you know struggling with memory loss?

Post by Julie G »

After sharing NF52's comments, the study coordinator provided a bit of clarification.
While this phase of recruitment is winding down, interested individuals can still check in here: https://apolloe4.researchstudytrial.com/ as they may continue to accept new individuals for a while longer.
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