November is National Alzheimer’s Disease Awareness month.
By 2050, as many as 16 million Americans are expected to be living with Alzheimer’s Disease. This past year we have seen a surge of Alzheimer’s focused clinical trials emerge, and with such a prevalence in the US as well as the rest of the world, it is important to take note of the continuous research taking place to fight this disease and what direction it’s heading in.
The brain is responsible for countless functions, some of which include memory formation, planning skills, and voluntary movements. All of these actions are controlled by neurons communicating with each other. The communication is usually facilitated by the neurotransmitter acetylcholine, which is a chemical neurons use to talk with each other. In the brain of a person with Alzheimer’s Disease, levels of this vital acetylcholine are lower, so not as many neurons are communicating with each other to store memories. When neurons are damaged, they express glutamate, another neurotransmitter that is heavily involved in learning and memory. Excessive glutamate can expedite the process of other neurons being damaged.
Unfortunately, there is no cure for Alzheimer’s. Current drugs are available on the market to alleviate the symptoms of Alzheimer’s, however none exist to treat or delay the disease. The four FDA approved drugs currently being prescribed by doctors are three cholinesterase inhibitors and memantine. Cholinesterase inhibitors (donepezil, rivastigmine, galantamine) work specifically by slowing down the destruction of acetylcholine. This way, more neurons are able to communicate with each other. Memantine, on the other hand, works by altering ion balance in damaged neurons, and preventing the release of more glutamate. These available therapies generally treat the symptoms experienced by patients with severe Alzheimer’s, such as agitation and aggression.
There are currently over 100 product candidates in the works across the country for Alzheimer’s Disease. There has been a recent shift in tactic, though. Attempting to treat Alzheimer’s once it has already become evident in a patient has proven to be extremely difficult, as the brain has been affected for many years prior to the emergence of the disease’s symptoms. At that point, the brain has experienced severe and irreversible damage. Now, researchers are focusing more on drugs that help combat the disease earlier on. Here at ClinEdge we have seen studies shift from targeting patients with severe Alzheimer’s disease to patients with early or pre-Alzheimer’s disease. This way, the focus of the drugs is to prevent or delay the onset of the disease, rather than treat symptoms in someone whose brain has sustained significantly more damage.
A significant inhibitor of trial success is the extremely high rate of trial participant screen failures; A 2016 report estimates it to be 85% for patients who are still early on in the disease spectrum. The development of more thorough and complex screening methods could be the key to decreasing screen failure for studies and getting at least a few more patients on board.
Even with the existing drugs, not every person affected by Alzheimer’s has the same response to treatment. Fortunately, we have seen an upswing in Alzheimer’s clinical trials being conducted by pharmaceutical companies. What trends have you noticed with recent Alzheimer’s Disease trials?
About ClinEdge and BTC Network
ClinEdge and BTC Network provide a full range of clinical and outsourced business services to clinical research sites, health systems, pharmaceutical companies, and CROs. Together, the two companies represent four business segments: two global networks of research clinics with over 1,000 physician investigators, site financial management, and patient recruitment/retention. The four business segments work together to enhance research site operations. Our financial management services include full Medicare coverage analysis, budget and contract negotiation, claims review, and receivable management. Recruitment and retention services include, but are not limited to, online engagement and advertising, a national patient database, patient travel concierge, national and local advocacy, and an in-house call center. With extensive experience across over 300 different medical indications representing all therapeutic areas, the ClinEdge and BTC Network teams have helped to successfully conduct thousands of clinical studies over the last several years.
Contact the ClinEdge team today for more information about how you can be successful with your studies!