March 9, 2021
Science

Where to Find Alzheimer’s Disease Clinical Trials

If you or a loved one has been diagnosed with Alzheimer's disease, you should know how to find and enroll in clinical trials in your area!
By
Tomohiro Takano
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If you or a loved one has recently been diagnosed with Alzheimer’s disease, there is a lot to consider. While it is important to get a treatment plan worked out with your primary physician and neurologist, you should also consider joining a clinical trial. Or, if you are a caregiver, you should consider talking to your patient about enrolling in a study.


Clinical trials do not guarantee that you will receive a life-changing treatment or medication. In fact, the entire purpose of clinical trials is to test how safe and effective a new form of treatment can be. That being said, there are lots of other reasons to join clinical studies - first and foremost being that you can help researchers find new and effective treatments for Alzheimer’s disease.


In this article, we discuss what Alzheimer’s disease is, the genetics of Alzheimer’s, current treatments of Alzheimer’s disease, and how to find and enroll in neuroscience clinical trials.

What is Alzheimer’s Disease?

Alzheimer’s disease is characterized by a progressive degeneration of brain tissue, related to the buildup of amyloid plaques and neurofibrillary tangles in the central nervous system (CNS). These clumps and tangles of loose beta-amyloid (a-beta) proteins inhibit the firing of neurons within the CNS - leading to symptoms of brain dysfunction and eventually dementia. Doctors can diagnose Alzheimer’s disease by testing brain health, neurodegeneration, and taking PET scans. Often, researchers use a tool known as the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (or Cog Test, for short) to quickly determine how advanced a person’s Alzheimer’s has progressed.


Dementia is a general loss of cognitive functions, which include things like reasoning, thinking, and logical processing. While the causes of dementia vary, Alzheimer’s disease is the leading cause of dementia in the elderly. Alzheimer’s dementia is a highly studied disease in neurology. Furthermore, Alzheimer’s disease is a progressive disease. Over time, parts of the brain shrink - leading to more cognitive symptoms and, eventually, death. Alzheimer’s disease is one of the leading causes of death, behind heart disease and cancers. 


The exact causes of Alzheimer’s disease are not yet known. However, like many neurodegenerative diseases (including Parkinson’s disease and others) it is assumed that both lifestyle choices (like diet and exercise) and genetics are risk factors in the development of the disease.

Genetics of Alzheimer’s Disease

Like most diseases that are not directly caused by genetic mutations, Alzheimer’s disease has a very complex relationship with genetics. Through genome-wide association studies (GWAS), scientists have found over 40 genes that seem to influence whether or not a person will develop Alzheimer’s disease. Of these genetic variants, the APOE gene is the best studied.


For instance, one version of the APOE gene increases your risk for developing Alzheimer’s disease. However, other variants of the APOE gene can actually provide a protective effect and make it less likely that you will develop Alzheimer’s disease. While some genetic testing companies provide information on the APOE gene and how it may influence your risk for Alzheimer’s, it is now known that the genetic landscape influencing the development of Alzheimer’s is much more complex than this single gene. Future genetic studies are being planned to shed more light on this area of research.

Are there Treatments for Alzheimer’s Disease?

While there are some medicines that can help treat the symptoms of Alzheimer’s disease, treatments for the underlying causes of Alzheimer’s disease are still being developed. For example, there are several medications that can help treat symptoms like increased anger and other behavioral problems. For example, cholinesterase inhibitors are a common treatment of Alzheimer’s symptoms (like memantine and other psychiatry drugs). There are also lifestyle changes that may help delay the progression of the disease for some time. Many of these lifestyle changes are promising in the preclinical stages of the disease, before symptoms, metabolic changes, and severe memory loss set in.


Some clinical trials are focusing on developing a treatment for the underlying causes of Alzheimer’s, while other clinical studies are focused on developing better treatments for the symptoms of the disease (like the monoclonal antibody treatments solanezumab, aducanumab, or crenezumab). Some of these treatments are progressing through clinical trials, while others (like aducanumab) have been delayed considerably.  


Both avenues are worth exploring, since scientists and researchers are not sure if an underlying cause of Alzheimer’s disease will be found or not. Keep in mind that there are clinical trials for patients with different levels of cognitive decline - from mild cognitive impairment (MCI) to well-developed dementia.

What Are Clinical Trials?

Clinical trials represent the final process in the development of a new drug, treatment, or testing procedure for a disease. For example, researchers may be testing new inhibitor medication, or they may simply be testing a newly found biomarker (like a substance in cerebrospinal fluid or glucose levels) that helps them determine cognition levels, a baseline of the disease, or may be risk factors. Drugs and treatments that have reached the clinical trial portion of testing have already bypassed initial safety testing in animals or through cellular methods. Each medication or treatment must undergo three phases of clinical trials before being approved by the Food and Drug Administration (FDA). 


Phase I tests the drug or treatment in a very small group of volunteers, essentially to ensure that no adverse side effects are seen and the tolerability of the treatment is high. In Phase II, a group of several dozen or even a few hundred volunteers are tested and researchers measure both the safety and efficacy of the new medication or treatment. By Phase III, researchers are testing thousands of trial participants. This final phase of clinical trials ensures that even the most rare of side-effects are found and the best statistical data can be harvested to see exactly how effective the new treatment is compared to older treatments. 

Why Do People Join Clinical Studies?

Contrary to popular belief, most people do not join clinical trials in order to get access to the “most advanced” Alzheimer’s treatments. In fact, clinical trials do not even guarantee that you will receive the new treatment. In order to properly assess how effective a treatment is, it must be compared to the current treatment or no treatment. Some clinical trials are also established to test open-label usage of drugs that have been approved for other diseases by modifying the dose or delivery method.


Sometimes, research participants are given a placebo - a non-active pill that simply looks like the new treatment. This helps researchers determine the actual effects of a medication instead of perceptions of how a patient feels like they are progressing. Most often, even the researchers do not know who is on the placebo and who is on the medication (a study design known as double-blind). Some studies also recruit healthy volunteers to provide research subjects into early Alzheimer’s disease, mild Alzheimer’s disease, and insights into early stage Alzheimer’s before patients are advanced enough to receive a clinical dementia rating. 


So, most people join clinical studies for a simple reason - to help others. By joining clinical trials you are helping researchers and doctors find effective and safe treatments for Alzheimer’s disease and the symptoms of dementia that it causes. Hopefully, future generations will not have to dread an Alzheimer’s diagnosis like people do today.

Where to Find Clinical Trials

The best advice to find and join a clinical trial is to start close to home. Begin by asking your doctor or healthcare provider if they know of or are involved with any clinical research themselves. Many neurologists have some sort of involvement with Alzheimer’s clinical studies. If not, check out this map of Alzheimer’s Disease Research Centers. You may be able to find an Alzheimer’s research center near you that has ongoing research trials you or your loved one can enroll in.


While these are often the best places to start, there are many organizations that compile research studies and connect you with the resources you need to get started with enrollment. Since studies are also specific to different levels of memory loss (MCI vs Moderate Alzheimer’s disease vs Severe Alzheimer’s disease), you must first have a neuropsychiatric evaluation to determine your eligibility. Check out the websites below for many other great clinical research studies in your area:


Citations

NIH - National Institute on Aging (NIA) - Alzheimer’s Disease Fact Sheet

Centers for Disease Control and Prevention (CDC) - Alzheimer’s Disease

U.S. National Library of Medicine - Alzheimer’s Disease

Current Opinion in Neurobiology - Genetics of Alzheimer’s Disease: where we are and where we are going

NIH - National Institute on Aging (NIA) - Alzheimer’s Disease Genetics Fact Sheet



Tomohiro Takano
Tomohiro Takano
Co-Founder and CEO