Page 1




Alzheimer’s symptoms. Media attention is growing, and the push is on for a breakthrough by 2025. This is a dramatic undertaking worldwide. Like World War II, we are recruiting troops, creating the weapons and building the infrastructure with allies around the world to fight a global war against Alzheimer’s disease.

Dr. Salloway, Director, Memory and Aging Program



Alzheimer’s disease (AD) research is gaining increased exposure around the world, and the Memory and Aging Program at Butler Hospital is playing a vital role in the studies being conducted to find a preventative solution to AD.

I urge you to help spread the word about the efforts that are taking place to end AD and to take action to assist in ending this major health care crisis that lies ahead of us by working together as a community to find a cure.

We are entering a critical period in AD research. There are promising new medications, and research advances are being published online and in medical journals almost daily. The National Institute of Health is partnering with the Pharmaceutical industry to provide research funds aimed at slowing the progression of

In this first newsletter, I’d like to extend a very warm welcome to those of you who have just recently joined our citizen army and give a huge thank you to all who have contributed to our mission. Partnering with patients, families and those at risk is critical to our fight against AD, and we will continue to do our part, working hand-in-hand with you.


Research Study Highlight


We have entered the era of Alzheimer’s disease (AD) prevention. Without a cure for AD, and with no proven treatments to delay memory loss associated with the disease, scientists are investigating whether certain medications can safely delay memory loss in people who are at risk for developing the disease. There is a global initiative to find breakthroughs for Alzheimer’s by 2025 and we need people to participate in clinical trials to help reach that goal.

The EARLY trial, sponsored by Janssen Research, is evaluating the safety and efficacy of an investigational medication to determine whether it can prevent memory loss associated with Alzheimer’s disease. The study will enroll 1,650 volunteers worldwide over the course of eight years. This trial is for people who have normal memory function in daily life and who aren’t being treated for memory problems and are 60 to 85 years of age. These people might be at increased risk for developing AD in the future, because they have evidence of beta-amyloid buildup in their brain (determined by a PET scan in the screening period) and other risk factors.

The EARLY trial has three parts that will take place over a five year period: 1. Screening Period – Exams, tests and other procedures are administered over three months to see if a participant qualifies for entry into the trial. 2. Treatment Period – Over 4.5 years the participant will visit our program every one to two months during the first 12 months of the treatment period. After that, visits will take place once every three months. Participants will receive either the investigational medication (oral tablet) or a placebo that will be taken daily. A placebo is a tablet that contains no medication. It will be decided at random whether participants receive the investigational medication or placebo. Neither participants nor our study team will know if the investigational drug or placebo is being given. 3. Follow-up Period - There is one follow-up visit one to four weeks after the last dose of trial medication. Also, participants will be contacted by telephone every six months for up to five years after the last dose of trial medication to check on their general health and memory function in daily life.

Often we’re asked, “Why should I participate in research?” Aside from helping advance science to find a cure for this epidemic it’s a way for people to take charge of their own health, help future generations and their communities and potentially receive a treatment before it’s widely available. Individuals who would like to learn more about the EARLY trial may call (401) 455-6402, email or visit the website MEMORY MATTERS | NOVEMBER 2017 | BUTLER.ORG/MEMORY

THE FACTS AND MYTHS OF CLINICAL TRIALS When we first talk to people in the community, we often hear concern about participating in clinical research because of misconceptions or not fully understanding the process. For those who have never heard about clinical research, it can be intimidating to learn about the process, the procedures and appointments. In this article we hope to address some of the top concerns people have, and share what really goes on when a person joins a clinical trial.

#1: They have plenty of people to participate. They don’t need me. We would love to have you and others you know join the fight against Alzheimer’s disease! The fact is that without volunteers – of all ethnicities – we will not be able to find a cure for this horrible disease. We urgently need people with and without memory problems to participate in over 225 Alzheimer’s and dementia clinical trials worldwide. With the many different types of trials that are being conducted, there may be one that is the right fit for each individual and family member volunteer – from treatment to observational to imaging only.

#2: I’m only going to receive the placebo. Depending on the trial design, there could be a chance that a clinical trial participant would receive a placebo. Each study is structured differently, but in a randomized trial participants may have up to a 50 percent chance of receiving the placebo. During the consenting process, a member of the clinical team will explain what the chances are of receiving the investigational medication. A person should

carefully consider their comfort level in not knowing whether or not they would receive a placebo before deciding to join a trial.

#3: Volunteers do it for the money. When volunteers are asked what motivated them to join a particular trial, the top reasons often include: helping self, helping others (i.e. family) and gaining access to medication that is not yet available to the general public. Some trials reimburse participants for travel, for undergoing certain procedures or coming to so many visits. A clinical trial participant is not likely to be able to plan that grand trip to Hawaii on clinical trial stipends, so it’s always best to discuss potential compensation with the specific trial site. The consent to join a clinical trial also outlines any compensation offered, or that may be incurred, as well.


#4: Clinical trials use unproven methods and medications and are dangerous – I’m just a guinea pig. Clinical trials are experiments so there will be some risk associated with them. However, the ethical and legal codes that our regular doctors have to follow, also apply to clinical trials. The larger trials are often federally regulated with built-in safeguards to protect volunteers. In fact, research participants are often more closely monitored in a clinical trial setting than by a regular doctor because of the safeguards and mandated reporting that is required by the FDA (Federal Drug Administration). During the consent process, the clinical team will review all potential side effects and risks associated with the investigational medication or procedure. Volunteers should thoroughly discuss and understand any side effects with the doctor and clinical team. It’s also important to understand that consent to participate in a trial is ongoing so at any time a research participant has the right to withdraw consent. As can be seen in the diagram above (Alzheimer’s UK), by the time a trial enters phases II and III, the regulatory body in a country (i.e. FDA) has deemed the investigational drug or procedure to be relatively safe in humans and acceptable for additional testing. Animal testing, if necessary, occurs in the preclinical phase five to 10 years before it’s tested in humans. Any concerns one has about joining a clinical trial can be brought up to his or her doctor and study team. They are trained in all the risks and benefits of joining a trial and would be happy to discuss any questions. The consent process occurs before undergoing any procedures and is a wonderful opportunity to ask questions and process the information. It’s important that individuals volunteering for research participation fully understand everything that is being asked of them and their families so never hesitate to ask if anything is unclear!


Caregiver Profile


1. How long have you had a connection with the Memory and Aging Program? I’ve been involved with the program for over two years now as a study partner with my Mom who has been part of a trial for Alzheimer’s treatment. 2. As a study partner – and son - to a clinical study participant, what has the (study) experience been like for you and your family? It has been challenging for my mom of course but also a source of hope. I remember us sitting with Dr. Salloway at the beginning of the process. She had the initial tests that proved her a strong candidate for the trial and was invited to participate. She looked to me and my Dad, who has since passed away, and asked “Do you think I should do it?” We both immediately said, absolutely. And I stressed to her that not only might it prove beneficial to her but the potential benefits for future generations would be something she could be very proud of. I think that it has helped

her a lot to know that her experience with the disease will be of great benefit to others. Like all great Moms, she is not shy of bragging about her children, she often tells people, “My son is an actor, he has a great memory.” I always remind her that that is exactly the reason to be part of the study. I am very aware that someday it could be a life changer for me. 3. Have there been any surprises for you about the clinical trial experience (or Alzheimer’s disease in general)? It’s a fascinating process and a great insight into the scientific method. It’s uplifting to see science in action, innovating to ease suffering and promote healthier and more productive lives. But doing so not by false promises and bromides but by rigorous trial and error. There may be no human achievement more important. We take it for granted but I can’t take any medication without being grateful to the year of sacrifice and hard work that went in to ensuring its effectiveness and safety.


The smallest change in the way our brains work can utterly transform us. Our memories form the core of our sense of self.

4. What advice would you give to families if a loved one wanted to participate in a clinical trial? Do it, if you can. Not only for moral reasons but for the actual care. The staff at the Memory and Aging Program are incredibly sensitive, warm and generous. They put a graceful human face on what is a very challenging time for many families. You are made to feel welcome and needed and that can make all the difference. 5. They say art often imitates life. As an actor, do you feel drawn to productions that speak about Alzheimer’s or other neuropsychological conditions? Very much so. Even before my personal experience, I have been very interested in the dramatic potential of the workings of the brain. When Christopher Hitchens, the great journalist and essayist was undergoing treatment for esophageal cancer, he remarked that his suffering reminded him that he didn’t have a mind, he was a mind. We are our brains. The idea of the self, of what makes us ‘who we are’ is contingent on the incredibly complex workings of this delicate organ in our skulls. The smallest change in the way our brains work can utterly transform us. Our memories form the core of our sense of self. What happens when they fade or disappear as they will to varying degrees for us all? What story could be more dramatic, more fundamental to the human experience? The next play that we are working on at The Gamm is the wonderful new play, Incognito by Nick Payne. It weaves the story of Einstein’s brain which was stolen by the pathologist who performed his autopsy with other tales based on historical cases of neurological disorder, including that of an acute amnesiac who forgets almost everything moments after it occurs but always remembers his profound love for his wife. Its a beautiful, moving and stunning look into the emotional and physical aspects of the self.


Staff Spotlight

DIANE MONAST, RN, BSN, CNS 1. How long have you been part of the Memory & Aging Program and what inspires you to come to work every day? I have been a part of this program since its inception 20 years ago. We have grown from a staff of six with one clinical trial to a staff of 30 with over 20 research trials! I love nursing and research and I am inspired by the mission of our program to find treatments for and possibly defeat AD in my lifetime. My family has been touched by Alzheimer’s, and I owe it to their memory to fight everyday against this devastating disease. 2. What’s one of the biggest misconceptions about clinical research and what do you say to people who are concerned about it? One of the biggest misconceptions about research I think people have is that it’s too much trouble or it’s not worth it because they might get placebo. There are risks to research sure, but you have an opportunity to move the science forward. If no one participates in research there would be no drug development and no disease cures. I like to look at it as the glass is half full. You have a chance to receive a drug that may possibly help a threatening illness that is not available to the general public. The care and attention our participants receive at our center is impeccable. We follow research subjects very closely, and we see them so often our staff develops wonderful bonds with our participants and their study partners. They really become like family to us! 3. What advice would you give to families if a loved one wants to participate in a clinical trial? I would make sure they understand all the details of the research project and discuss it with their families, doctors and our staff. I would tell them it’s an opportunity to participate in ground breaking research and be part of the search for effective treatments. Our research physician believes we need a “citizen army” to come forward and help us in this fight and I truly feel that way. Our research participants inspire me every day with their dedication, courage and commitment to this cause. 4. What’s something that might surprise others about you? I am a total foodie! I collect cook books and kitchen gadgets. I have over 100 cookbooks in my collection, and my gadgets are spilling out of all my cupboards! I love to try all kinds of cuisine, but my favorites are Mediterranean/middle eastern and Asian. I love to bake and I bring in treats for the staff just about every week. If you’re ever here on a Monday, you just might get a piece of a goodie!

RESOURCES FOR PATIENTS AND CAREGIVERS Butler’s Alzheimer’s Prevention Registry Rhode Island Alzheimer’s Association 24/7 Hotline 1.800.272.3900 Brain Health Registry Genetic Information Nondiscrimination Act

EVENTS Driftwood Alzheimer’s Fundraiser The 5th annual fundraiser for Alzheimer’s disease, Driftwood III, was held on Saturday, November 18 at the Museum of Work and Culture in Woonsocket, RI. Attracting almost 300 people, the event is hosted by one of our own Heroes and Pioneers, Paul Cote. His family has been deeply affected by Alzheimer’s disease, and through his heartfelt artwork, Paul is making a difference in the fight against this horrible disease. The gala included performances by the State Ballet of Rhode Island, the Sound of Gravity and Blue Man Group–all of whom donated their talents for this cause. Their generosity, as well as ticket buyers and silent auction bidders, benefit the RI Chapter of the Alzheimer’s Association and Butler’s Memory and Aging Program, with more than $6000 going to Butler’s program. The monies will support our research efforts.


We Want YOU to Join the Fight Against Alzheimer’s Disease As part of our inaugural group of registrants, we need your help to spread the word about the registry. We ask that you help promote its growth by educating your friends and family members about our mission – to end Alzheimer’s disease...

In the top 10 causes of death in the United States, Alzheimer’s disease ranks sixth and it is the only top 10 cause for which there is still no treatment or known prevention. There is heightened awareness of the need for a cure amongst leaders in both public and private research funding sectors; however, money alone will not cure AD. We ultimately need community action and volunteerism from people just like you to get involved in research opportunities. Many people believe that researchers already have plenty of people to participate in their studies and they don’t need anymore. That is simply not the case. The truth is 80-85% of people who screen for AD prevention studies do not qualify for the trials being conducted. We need to screen thousands of people to find a few hundred who are eligible to participate. This is why we created the Butler Hospital Alzheimer’s Prevention Registry! The registry is our recruitment hub. It opened to enrollment in April, 2016, and in just over 16 months we have over 500 registrants! We are thrilled that you have joined the registry and want to receive the latest information about Alzheimer’s disease and research opportunities that you might be eligible to participate in. As part of our inaugural group of registrants, we need your help to spread the word about the registry. We ask that you help promote its growth by educating your friends and family members about our mission – to end Alzheimer’s disease – and encourage them to join us in the fight. As the word spreads and we gain momentum in growth, we have established a goal 1,200 registrants by January, 2018! Please help us achieve it! Spread the word, post on Facebook, write a letter to the editor of local newspapers, share with your congregation, tell your hairdresser and exercise classmates; any ear you can grab, grab it!



You are receiving The Memory Matters newsletter because of your current or past relationship with Butler Hospital's Memory & Aging Program, our research program or with the patients/family members we serve. If you would like to be removed from the mailing list and not receive future editions, please contact us at or 401-455-6402.


Memory and Aging Program 345 Blackstone Boulevard Providence, Rhode Island 02906 (401) 455-6402 A Major Teaching Affiliate of

Memory Matters  
Memory Matters  

Butler Hospital's Memory and Aging Program newsletter, fall edition. Includes information on research, the team, and how to sign up for the...