People with a family history of Alzheimer's disease (or memory loss) may have a greater risk for developing the disease. Great Lakes Clinical Trials is conducting a research study of an investigational medication intended to prevent progression to Alzheimer's disease.
Alzheimer’s is one of our country’s most urgent public health crises. There are currently 5.4 million Americans living with Alzheimer’s, that number expected to rise to 14 million by 2025. That’s why participation in Alzheimer’s studies is so important. In fact, the first person to be cured of Alzheimer’s will be a clinical trial participant.
We are moved by this personal account published on HuffPost earlier this week of dealing with HS. It reminds us of the importance of studies like our current hidradenitis suppurativa study in helping people manage their lives.
This participant’s message is very strong. Great Lakes Clinical Trials is proud to have worked with Us Against Alzheimer’s in filming this video at our clinic.
“It gives me a sense of purpose and power over the disease to know that I’m participating in what could lead to the cure that’s going to really help so many people.”
We have a wide range of memory-related studies enrolling volunteers right now at our Arlington Heights and Andersonville clinics. These include studies in people who have already been diagnosed with Alzheimer's disease, as well as studies for those individuals who are just starting to have noticeable concerns about their memory. We also have studies for those who have good memory now, and want to prevent memory loss in the future.
Call now to speak to one of our patient care representatives at (773) 275-3500 or click the button below to be contacted by one of our staff.
From treating depression to helping manage alcohol addiction, researchers say legal medical “magic mushrooms” have many potential benefits.
Soft lighting. Comfortable furniture. Art decorating the walls.
To the untrained eye, this setting appears to be a living room. But it’s not. It’s a research facility specially designed to evoke comfort and ease.
A psilocybin therapy session is taking place.
On the couch lies a patient. They have eye shades and headphones on. Gentle music is playing. Two members of the research team are present to help guide the session over the course of eight hours. Much of this time will be spent in quiet introspection.
Trained medical staff are on-site, should anything unexpected happen.
Despite the trappings of normalcy, this therapy session is anything but.
Psilocybin, the active ingredient found in “magic” mushrooms, or “shrooms,” is a powerful psychedelic.
Despite being about 100 times less potent than LSD, it’s capable of altering perception of space and time, causing visual distortions, euphoria, and mystical experiences.
Unlike marijuana, which has seen a dramatic shift both in terms of support of legalization and recognized therapeutic uses, or MDMA, which has grabbed headlines in recent years for its potential to treat PTSD (some researchers believe the drug could see Food and Drug Administration approval as soon as 2021), psilocybin lacks the same degree of cultural cachet.
And one could be forgiven for thinking of “shrooms” as nothing more than a remnant of the excess of the psychedelic 1960s.
But make no mistake: Psilocybin has a number of potential medical benefits.
The State of Psilocybin Research
Research has shown psilocybin to have potential to treat a range of psychiatric and behavioral disorders, although it’s yet to receive FDA approval for anything.
Its potential indications include depression, obsessive-compulsive disorder, quitting smoking, alcohol addiction, cocaine addiction, cluster headaches, and cancer-related or other end-of-life psychological distress.
High-profile initiatives have also popped up in recent months in Denver, Colorado, and Oregon to decriminalize psilocybin mushrooms.
However, experts say they’re unlikely to pass.
Psilocybin mushrooms remain a Schedule I drug according to the Drug Enforcement Agency, meaning they’re classified as having “no currently accepted medical use and a high potential for abuse.”
Other Schedule I drugs include marijuana, MDMA, and LSD.
Yet, despite social stigma and legal red tape, researchers are forging ahead with clinical trials for FDA approval.
Dr. George R. Greer, co-founder and president of the Heffter Research Institute, a non-profit research center that focuses on the therapeutic uses of psychedelics, particularly psilocybin, explains his motivations:
“Our mission is two-fold: one to do research that helps us understand the mind, the brain, how all that works, and number two, to help reduce suffering through therapeutic use of psychedelics.”
The institute is currently focused on two main areas of psilocybin research: addiction and cancer-related psychiatric disorders. Cancer-related psilocybin therapy is considered one of the most promising areas of research for the drug.
However, considering the vast number of potential indications for psilocybin, it’s important to keep in mind that the amount of research also varies widely, from single pilot studies to phase II or III approval trials by the FDA.
Here’s what the current research says about psilocybin treatment for some potential indications.
Depression is among the most researched indications for psilocybin therapy. As Healthline previously reported last year, psilocybin therapy was given “breakthrough therapy” designation (a review fast track) by the FDA for the treatment of depression.
The Usona Institute, a psychedelic research center, is currently in the planning stages of their phase III trial, which will likely begin this year.
Smoking Cessation and Other Addictions
In a small pilot study from Johns Hopkins University, researchers found that psilocybin therapy significantly improved abstaining from smoking over a 12-month follow-up period.
Matthew Johnson, PhD, associate professor of psychiatry and behavioral sciences at Johns Hopkins University School of Medicine, led that study.
According to him, psilocybin also has potential to treat other substance use disorders, including alcohol and cocaine addiction.
“The general idea is that the nature of these disorders is a narrowed mental and behavioral repertoire,” he told Healthline. “So, [psilocybin] in well-orchestrated sessions [has] the ability to essentially shake someone out of their routine to give a glimpse of a larger picture and create a mental plasticity with which people can step outside of those problems.”
In fact, a small open-label study on psilocybin and alcohol dependence found that following treatment, both drinking and heavy drinking declined.
Researchers in Alabama are also currently conducting trials for psilocybin therapy on cocaine addiction.
Cancer-related Psychological Distress
“There’ve been some promising preliminary results in such areas such as the treatment of overwhelming existential anxiety in people who are facing the end of life,who have diagnoses of advanced-stage cancer,” Dr. Charles Grob, professor of psychiatry at the UCLA David Geffen School of Medicine, told Healthline.
Grob, who’s also affiliated with the Heffter Research Institute, has studied psilocybin extensively and authored research on the subject, including, among other things, a pilot study in 2011 on psilocybin treatment for anxiety in people with cancer.
A randomized, double-blind trial from Johns Hopkins in 2016 found that a single dose of psilocybin substantially improved quality of life and decreased depression and anxiety in people with life-threatening cancer diagnoses.
“The thing that we have the most evidence for is cancer-related depression and anxiety. That seems really strong, and I’d be surprised if those results didn’t hold up,” Johnson said, who was part of that research.
Will Psilocybin Ever Be Approved by the FDA?
Despite promising research, there’s no realistic timeline for when, or if, psilocybin will ever be approved by the FDA.
All three experts interviewed by Healthline stress that the substance can be dangerous for a host of different reasons if administered incorrectly.
“It will only be administered in a clinic by specially trained and certified therapists, physicians. It’s never gonna be available out on the street where people can sell it or take too much, or take too many of their pills from a prescription,” Greer said.
Psilocybin affects the cardiovascular system and can lead to increased blood pressure or irregular heartbeat.
It also has the potential to cause serious and permanent psychological problems.
“Psilocybin is a lot more psychologically dangerous than cannabis, and it’s especially dangerous for a small percentage of the population who have had an episode of psychosis or mania, manic episode, or even, say, a close family member whose had those problems, because it can trigger a psychosis or manic episode in a person who is vulnerable to that,” Greer said.
And there’s always the chance of a “bad trip,” or negative experience while taking the drug. There are rare but documented cases of individuals jumping to their deaths or otherwise behaving erratically in such a way that endangers themselves or those around them.
As Grob puts it: “Taken in uncontrolled settings, honestly, all bets are off. You don’t know what you’re gonna get.”
But psilocybin therapy is nothing like taking shrooms at a party. It’s meant to be a meticulously controlled environment to ensure that nothing unexpected happens.
“You name the risk, and we have really good mechanisms for addressing it,” Johnson said.
He further explained, “There are risks, but they are dramatically reduced in medical research and potentially in approved medical use, and I would argue that those risks and our ability to address them fairs very reasonably compared to many procedures that are routinely used in medicine.”
Nonetheless, the safety and efficacy of psilocybin treatment must still be satisfactorily proved to the FDA, which, thus far, it has not.
While some are optimistic that psilocybin may follow in the footsteps of MDMA therapy and potentially even have approval within the next 5 to 10 years, its pathway is far from clear and very uncertain.
When asked if there’s a realistic timeline for approval, Grob told Healthline, “I don’t think so. Even though the research we’re talking about has by and large been very positive and encouraging, there hasn’t been enough research.”
“There needs to be more FDA-approved clinical research with psychedelics,” he added, “exploring both how to optimize their therapeutic potential but also trying to get a better understanding of the range of medical effects, which may be problematic… There’s still some questions that need to be answered.”
Written by Gigen Mammoser on February 12, 2019
Great Lakes Clinical Trials is proud to announce a collaboration with the McGaw YMCA in Evanston, IL to study the effect of exercise on slowing down and/or preventing future memory loss.
The EXERT study is a national, 18-month long, clinical trial to test whether physical exercise can slow the progression of mild memory loss and/or mild cognitive impairment in older adults between the ages of 65-89. It is a Phase III randomized, controlled trial examining the effects of exercise on cognitive function and on biological markers in older adults with mild memory loss. The EXERT study will test whether aerobic training, or stretching/balance/range of motion exercise, can improve memory and thinking skills and other measures of brain health in people with mild memory loss or lapses.
The Generation Program is made up of two clinical trials: Generation Study 1 and Generation Study 2. The trials will enroll people with a specific gene that may increase the risk of developing Alzheimer’s disease. It is your genes, along with other information about you, which will determine whether you are eligible to take part in either of these studies.
Overview of the Generation Program
The Generation Program focuses on people ages 60-75 who do not have symptoms of Alzheimer’s disease but who have one or both of two factors that are known to increase a person’s risk of developing dementia caused by Alzheimer’s disease. Those factors include:
The APOE e4 Gene – People who have one or two copies of the gene APOE e4 are more likely to develop dementia due to Alzheimer’s disease. It is important to note that not every person who has the APOE e4 gene will develop dementia caused by Alzheimer’s disease.
·Elevated Amyloid Plaques – Amyloid is a protein produced normally in the brain. Recent research studies suggest that people over the age of 65 who have evidence of higher than normal levels of amyloid plaques in their brains are at higher risk for dementia due to Alzheimer’s disease. However, not every person who has higher than normal levels of amyloid plaques will develop dementia due to Alzheimer’s disease.
Frequently Asked Questions
How do doctors determine whether someone has high levels of brain amyloid?
In one of two ways. 1) A PET scan test for brain amyloid (also referred to “brain amyloid scan” or “amyloid PET scan”) allows physicians to detect amyloid plaques in the brain. 2) Amyloid can also be measured through collection of cerebro-spinal fluid from a lumbar puncture.
Participants in Generation Study 2 will learn whether the level of amyloid in their brain is either “elevated” or “not elevated.” Please note that amyloid tests do not measure whether you have dementia due to Alzheimer’s disease nor can they predict whether you will develop dementia due to Alzheimer’s disease in the future.
How is an amyloid PET scan performed?
The test takes about two hours to complete. First, the person is given an injection of a dye (called a “radiotracer”). About an hour later, the person undergoes a 20-minute scan exam.
During the exam, the radiotracer dye “lights up” where amyloid plaques are located and the PET scan turns this information into images. A qualified expert will then assess the images to determine whether the level of amyloid is “elevated” or “not elevated.”
How is a lumbar puncture performed?
During this procedure, a thin needle is inserted into the lower part of the person’s spinal column to collect spinal fluid. The amount of amyloid in the spinal fluid is then measured to determine whether the level of brain amyloid is “elevated” or “not elevated.”
What does an “elevated” level of brain amyloid mean?
An “elevated” amyloid result means that you have enough amyloid plaques in your brain to meet the criteria that make you eligible to participate in the study. While an “elevated” amyloid result is associated with an increased risk of developing dementia due to Alzheimer’s disease, it does not mean definitively that you will develop dementia due to Alzheimer’s disease.
Studies suggest that the increased risk of developing dementia due to Alzheimer’s disease associated with an “elevated” amyloid level is spread out over years or even decades. Scientists do not yet know which people with normal memory and thinking ability as well as elevated brain amyloid will develop dementia due to Alzheimer’s disease. Some people with elevated levels of amyloid plaques in their brain may never develop dementia in their lifetimes.
Is an “elevated” level of amyloid similar to other risk factors?
Having an “elevated” level of amyloid plaques may increase the risk of developing memory problems and dementia due to Alzheimer’s disease but it does not mean a person will definitely develop dementia due to Alzheimer’s disease.
Studies suggest the relationship between elevated amyloid plaques and Alzheimer’s disease dementia may be similar to the relationship between cholesterol and heart disease. Having high cholesterol increases the risk of having heart disease, but having high cholesterol does not mean that person will definitely have a heart attack. Years of research involving thousands of people enabled us to calculate a person’s risk of heart disease. There are not yet enough amyloid test research results available to calculate an individual’s risk of developing Alzheimer’s disease-related memory decline.
There are some factors that may protect a person from developing memory or thinking problems, even if they do have elevated levels of amyloid plaques. For example, some protection may come from a person’s genes, but good general health and a healthy lifestyle may also lower the risk of Alzheimer’s disease-related memory decline.
What does a “not elevated” level of brain amyloid mean?
A “not elevated” amyloid result means you do not have enough amyloid plaques in your brain to be eligible to participate in the Generation Study 2. Having elevated brain amyloid is not an eligibility requirement for Generation Study 1. A “not elevated” amyloid result does not mean that you will never develop dementia due to Alzheimer’s disease. A person who has a “not elevated” amyloid level at the time of testing could in the future develop an “elevated” level of amyloid or dementia due to Alzheimer’s disease.
Are there other risk factors in addition to the APOE e4 gene and amyloid plaques that can lead to dementia caused by Alzheimer’s disease?
Yes. The greatest risk factor for developing dementia caused by Alzheimer’s disease is advancing age, especially for those who are over 70 years old. However, dementia caused by Alzheimer’s disease is not a normal part of aging.
Another risk factor is having a family history of dementia or Alzheimer’s disease. Some studies also indicate that cardiovascular disease and conditions such as diabetes and high blood pressure are associated with a higher risk of developing dementia due to Alzheimer’s disease as well as other types of dementias. If you have any questions regarding these risk factors, please consult with your study team.