Dave Hodes
The conditions that psychedelics can treat have doubled in the last few years to include migraine headaches, Parkinson’s disease, autism, alcoholism, drug addiction, gambling addiction, and more.
But one of the more intriguing conditions that researchers are looking at is Alzheimer’s disease, a disease that has evaded the best efforts of treatment by medical science since it was first discovered in 1906, named after German physician Dr. Alois Alzheimer.
The disease affects 6.2 million Americans; global cases are forecast to be over 150 million by 2050, nearly triple the number in 2019.
Finding treatment for Alzheimer’s has been the focus of growing government assistance for years, most recently when a $350 million increase for Alzheimer’s and dementia research funding at the National Institutes of Health (NIH) was signed into law in 2019, bringing the annual funding to $2.8 billion.
Slow Alzheimer’s Progress
But progress toward a treatment has been slow going.
For example, on June 7, 2021, U.S. Food and Drug Administration (FDA) approved aduhelm (aducanumab) for the treatment of Alzheimer’s using the accelerated approval pathway, which can be used to advance research for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.
Aduhelm offered a brief glimmer of hope with claims that it could actually slow the progression of the disease. But after backlash from the medical community (in part because of a common side effect of swelling in areas of the brain, with small spots of bleeding), restrictions on its use by Medicare, and questions about the FDA’s approval process, the pharmaceutical company that makes aduhelm, Biogen (NASDAQ:BIIB), essentially dropped it in May, 2022. (Biogen is reportedly working on another formulation for treating Alzheimer’s).
That failure to bring to market the first approved Alzheimer’s drug in 20 years by a well-capitalized biotech company that posted $11 billion in revenue in 2021 has served to incite more activity in alternative therapies—such as psychedelics—to save the day and change the Alzheimer’s treatment narrative going forward.
In fact, the psychedelics industry has been flirting with finding a successful treatment for Alzheimer’s since 2015, years before Biogen took their shot at a drug, when Eleusis, a life science company based in London and New York, conducted two clinical trials of lysergic acid diethylamide (LSD) focused on establishing a basic framework for the future clinical development of psychedelics in the context of Alzheimer’s disease and depression.
On the surface of the issue, Big Pharma appears to have the upper hand for now. In 2020, there were 121 therapies in clinical trials for Alzheimer’s disease.
And there is a handful of big mainstream biotechnology companies still pursuing Alzheimer’s drug development—including Cassava Sciences (NASDAQ: SAVA), moving forward with their phase 3 studies of Alzheimer’s; Annovis Bio (NYSE: ANVS), announcing in May positive feedback from the FDA for two phase 3 clinical trials with their Alzheimer’s and Parkinson’s drug, buntanetap; and Alector Therapeutics (NASDAQ:ALEC), with three Alzheimer’s programs in the pipeline—two in partnerships with one of the largest pharmaceutical companies, Abbvie, which has $50 billion invested in overall research and development for various classes of pharmaceuticals.
Other biotech businesses pursing Alzheimer’s treatment are Biohaven Pharmaceuticals, AZ Therapies, VTV Therapeutics, AgeneBio and others, all showing little or no success so far, effectively causing biotech businesses to put Alzheimer’s work on the back burner.
The World Health Organization registry shows that there were 170 drugs in development for Alzheimer’s worldwide in 2020, contrasting with 433 for diabetes. Pfizer reportedly completely abandoned Alzheimer’s research in 2018 and laid off 300 employees. It’s this sort of disparity that reflects biotech’s problems: limited availability of biomarkers, longer trial durations, greater expense, and higher risk of failure of Alzheimer’s drug development programs, according to a study published by the Alzheimer’s Association.
Psychedelics Tackle Alzheimers
Psychedelic companies are sensing an advantage now to come up with an Alzheimer’s treatment that stands up to the challenges of both FDA scrutiny and patient benefit. Treatment for this disease is right in its wheelhouse.
Studies with psilocybin and LSD, coupled with anecdotal reports of cognitive benefits from micro-dosing, suggests that psychedelics may have a therapeutic role in a range of psychiatric and neurological conditions due to their potential to stimulate neurogenesis, provoke neuroplastic changes and reduce neuroinflammation—what mainstream pharma has been attempting to do with their newer chemical concoctions to treat Alzheimer’s over the last five years. Psychedelics also induce brain plasticity and modify connectivity between brain regions which is thought to help patients with Alzheimer’s.
In fact, all known genetic and environmental risk factors for Alzheimer’s are associated with increased inflammation, suggesting that reducing inflammation could be a target for preventing Alzheimer’s. Psychedelics have been shown to have potent anti-inflammatory properties and may represent a unique anti-inflammatory overwhelmingly targeted to brain tissue. “This inevitably makes them (psilocybin and LSD) interesting candidates for therapeutics in dementia,” a study concluded.
So it seems that biotech businesses have tried and failed to find a treatment for Alzheimer’s, and it’s time for psychedelics to take their shot.
In December, 2021, Mynd Life Sciences (CSE: MYND) (OTC: MYNDF) acquired Cava Healthcare Inc., a life sciences company based in Surrey, British Columbia, which included all future worldwide rights relating to the use of psychedelics to treat Alzheimer’s disease and other dementias.
And right now, there are three psychedelics clinical trials running or recruiting participants for studying the effect of psychedelics on Alzheimer’s, including one sponsored by Johns Hopkins University using psilocybin to see if it’s safe and effective for depression in people with mild cognitive impairment (MCI) or early Alzheimer’s disease.
The study will also assess whether psilocybin may improve an Alzheimer’s patient’s quality of life. The study began in March, 2021 with results expected in late December, 2023.
Other psychedelics companies in the race for an Alzheimer’s treatment include Ixtlan Bioscience, based in Tel Aviv, which recently announced a new patent for psilocybin treatment of Alzheimer’s.
For now, it’s a sort of standoff: take one of the usual six medications for treating the symptoms of Alzheimer’s and suffer through side effects of nausea, increased bowl movement, vomiting and loss of appetite. Or accelerate the trials and spread out the funding to more psychedelics companies to finally arrive at a psychedelics-assisted therapy that treats the symptoms without a list of grim side effects—going far beyond anything that mainstream medicine has available now for Alzheimer’s.
Could psilocybin, or LSD, or some new related psychedelic formulation yet to be discovered stop the progress of this terrible neurological disorder? Could they even reverse it altogether? For the first time in a long time, that possibility is not as improbable as it used to be.
