March 16, I wrote an article about NeuroEPO (also known as NeuralCIM), an Alzheimer’s treatment developed in Cuba.

There is a lot of interest in NeuroEPO due its successful clinical trials in Cuba. For a variety of regulatory and political reasons, the developers of the drug partnered with the College of Medicine at the University of Saskatchewan for a clinical trial to test if NeuroEPO improves or maintains cognition in adults with mild to moderate AD.

Several people have contacted me requesting information about both the clinical trial and obtaining the drug in Cuba. I have finally connected with the correct people.

The Canadian clinical trial for NeuroEPO is an active Phase 2 study targeting mild-to-moderate Alzheimer's Disease. It is being sponsored and conducted by the University of Saskatchewan under the leadership of medical professors Dr. Ron Geyer and Dr. Andrew Kirk.

Trial Design & Novel Delivery

• Objectives: The study aims to validate earlier Cuban trial results in a Western regulatory environment, specifically testing whether NeuroEPO can maintain or improve cognition while verifying its safety profile.

• Nose-to-Brain Delivery: Unlike standard injections, the trial utilizes a specialized, needle-free delivery system (a cannula attached to a syringe or specialized device). This targets the upper nasal region, allowing the drug to bypass the liver and travel directly to the brain within minutes to minimize systemic side effects.

• Duration: Participants are randomized to receive either NeuroEPO or a placebo intranasally three times a week for a full year (52 weeks).

• Advanced Monitoring: The trial incorporates highly advanced biomarkers not extensively used in previous phases, including MRI brain-volume measurements and tracking biological markers like beta-amyloid, phospho-tau, and APOE genes.

Core Eligibility Criteria

To participate in the Canadian trial, patients must meet strict inclusion and exclusion metrics:

1. Age: Participants must be 50 years of age or older (though some trial portals list a broader 18+ baseline, the strict protocol targets the standard Alzheimer’s demographic).

2. Cognitive Status: A diagnosed mild-to-moderate clinical stage of Alzheimer’s, supported by specific cognitive test baselines (such as a Mini-Mental State Examination score between 14 and 26).

3. Medication Restrictions: Participants must not be taking anticoagulants (blood thinners) or certain psychoactive medications. If a patient is taking standard Alzheimer’s medications like Memantine or AChE inhibitors, their dose must be entirely stable for at least 12 weeks before screening.

4. Support System: The patient must have permeable nasal airways and a dedicated caregiver willing and physically/mentally able to assist with the treatment and 14 distinct clinic visits over the year.

If you want to travel to Cuba:

• NeuroEPO is officially approved for use by Cuba’s Ministry of Health; therefore, the drug is legally available there. United States citizens can travel to Havana to receive the treatment at specialized medical tourism facilities like La Pradera International Health Center.

• United States citizens can travel to Cuba under the authorized specialized medical care travel category. Several airlines, including American and Delta, offer direct flights to Havana from Miami and Tampa. La Pradera International Health Center can assist with ground transportation from and back to the airport.

• Upon arrival at La Pradera International Health Center, you will undergo an evaluation, and if you qualify, you are prescribed the drug and taught how to administer the intranasal doses. I believe the health center will sell you the drug. (I have requested prices from La Pradera but they have not responded. I will publish the prices as soon as I receive them.)

• It may be possible to make the trip without an overnight stay. American Airlines has a flight departing Miami at 7:03 am. It arrives in Havana at 8:20 am. There is a return flight departing Havana at 6:25 pm. You arrive in Miami at 7:45 pm. This should give you enough time to have an evaluation at the health center, purchase your medication, eat dinner at Los Mercaderes, and make your flight to Miami.

• My sources cautioned that the feeling in Cuba is that Trump could order military action at any moment. You have been warned!

I hope this information helps.

Pharmaceutical companies spend a tremendous amount of research and development (R&D) funds to develop new drugs. Without approval from the Food and Drug Administration (FDA) to commercialize their newly-developed drugs, there is no return on their investment. The process for obtaining FDA approval is meticulous, expensive, and sometimes takes longer than several years to complete.

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The Prescription Drug User Fee Act (PDUFA) was created in 1992.1 In a nutshell, PDUFA allows the FDA to collect fees from drug manufacturers. The funds are meant to supplement the FDA’s appropriated operating budget. The additional funds should be used to improve the efficiency of the Center for Drug Evaluation and Research (CDER).

The PDUFA was created as a reaction to the rapidly growing volume of new drug applications (NDAs) and biologics license applications (BLAs). The FDA’s appropriated budget was insufficient to hire enough staff to handle the volume of NDAs and BLAs. The average time to review and approve an NDA was 27 months. Drug developers, regulators, and patient advocates applied pressure on Congress to find a solution to the lengthy review process. Congress created the PDUFA and President H. W. Bush signed it into law in October 1992.

There are many regulatory parts to the PDUFA, and it has been revised over the years; however, the primary result is the pharmaceutical industry funds its own regulator.

Since 1992, the FDA operates under an inherent and systemic conflict of interest. While tasked with acting as an independent watchdog to protect public health, the agency relies on the very pharmaceutical companies it regulates to fund nearly 70% of its drug review budget.

The application fees for new drug review and approval are steep!

• Application requiring clinical data $4,682,003 - Full new drug or biologic applications (NDAs/BLAs).2

• Application not requiring clinical data $2,341,002 - This is exactly half of the full fee and is typically for supplements.

There are a few exemptions and waivers:

• Small Business Waiver: A company employing fewer than 500 people can have the fee waived entirely for its very first drug application.

• Orphan Drugs: Applications for drugs designated for rare diseases or conditions are exempt from PDUFA application fees.

In addition to the application fee, there is a Prescription Drug Program Fee. It is $442,213 per year per approved product (capped at five per company).

Americans always wonder why drugs are so much more expensive in the United States compared to Canada, Mexico, European Union countries, etc. While there are a number of reasons why drugs cost more in the United States, I believe the greatest reason are the FDA fees. The United States relies heavily on corporate cash to fund the FDA. Other countries generally fund the majority of their drug regulatory agencies with tax dollars.

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I am developing several articles that will be published starting tomorrow.

A 2022 study titled, “Subcortical Correlates of Sleep in Neurodegenerative Diseases” is fascinating. Like everything related to Alzheimer’s, the results of this study are another piece of the puzzle.

I have been busy learning the FDA new drug approval process. It is a troubled and troubling process. The application fee for a new drug review and approval is $4,682,003. Why such a large barrier? I will bring you all the details tomorrow.

I think you will enjoy reading the blog post I published this afternoon.

Greg

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Before a drug can be sold in the United States, it must be approved by the United States Food and Drug Administration (FDA). The approval process is meant to ensure that drugs, both over-the-counter and prescription, do what they claim to do and that their health benefits outweigh their known risks.

The review and approval process begins with the drug manufacturer submitting their clinical trial data (and numerous other data about their marketing plans, dosage, benefits, risks, etc) to the FDA’s Center for Drug Evaluation and Research (CDER). From that point, a rigorous scientific review process begins. The process should be restricted from outside influences that may nudge the CDER to make a decision that conflicts with the submitted scientific data.

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I have never been much of a sports fan. Growing up, my Dad kept me busy after school and during the summers working at the family business. During college, I became involved in student government and other activities. I remember family holiday gatherings everyone would watch football games after we ate. I would be so disinterested. The family joke was that I did not know the difference between a football and a basketball. Later, when I owned a business, my assistant would hand me an index card every Monday morning with scores and highlights from weekend games. The note allowed me to participate in conversations with clients.

Now that Alzheimer’s disease has turned my life upside down, I have time to watch sports and follow a few teams. I also learned that a basketball is round, and a football is somewhat oval! Oh yea, I have recently learned about hockey pucks.

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Focused ultrasound, when combined with the intravenous injections of microbubbles, safely and transiently opens the blood-brain barrier (BBB). Opening the BBB can enhance the delivery of a variety of therapeutic agents to the brain.

Today, I am bringing you an update on a project that is funded in part by the Focused Ultrasound Foundation.

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A recent study conducted at Kindai University in Osaka Japan shows promise that arginine, a common, low-cost amino acid may suppress amyloid plaque buildup in vitro (in laboratory), and that the oral administration of arginine not only reduces amyloid plaque, but also exerts therapeutic benefits in fruit flies and mouse models of Alzheimer’s disease (AD).

Interesting Feature At Kindai University

Located on the 6th floor of Grand Front Osaka’s North Building, in an area known as the Knowledge Capital, this university-run restaurant serves tuna and other types of fish bred at Kindai University Fisheries Laboratory in Wakayama Prefecture, along with vegetables and other produce from Wakayama. The popular eatery is also a showcase for Kinki University’s world-first achievement in breeding tuna via full-cycle aquaculture.

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I have been a bit under the weather. Clammy skin and chills have been bothering me for about a week. This is a known adverse effect of Lecanemab. The chills would not normally last two we…

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• LifeArc Finger-Prick Blood Test

• Alector Therapeutics AL137

Today, let’s dig deep into Arrowhead Pharmaceuticals’ ARO-MAPT.

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After a three-hour nap when I arrived at home after my infusion, I became curious about the difference between Lecanemab and Donanemab. Before I started my infusions, I learned a bit about the differences of these two medications. At that point, I was a newbie to the world of Alzheimer’s. I recall writing in an early blog post that I was “scared shitless.” Fast-forward three and a half months and I consider myself a well-informed, untrained, amateur Alzheimer’s patient and seeker of information. In other words, I know a thing or two about Alzheimer’s disease.

Let’s take a moderately deep dive into Lecanemab and Donanemab.

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This photo shows the fear and worry of a family in Venezuela in the early morning hours of January 3. The United States military had just attacked their country.

At the moment this photo was taken, there were many more questions than answers.

What effect does a military attack and war have on people’s mental health? Specifically, does exposure to war increase someone’s likelihood of becoming depressed and developing dementia?

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