The Whitworths of Arizona, bringing science to you in everyday language.

Friday, October 11, 2019

2019 ILBDC: Caregiver Empowerment, Pt.3

This is the third in a series called The Four Pillars of Caregiver Empowerment, presented at the 2019 International LBD Conference in Las Vegas by Angela Taylor. The first pillar was about thinking ahead. The second was about using your resources and developing your skills. This week's blog is about a subject that many care partners neglect to do, caring for yourself. Yet, it is probably the most important task you have. YOU are your most important caregiving tool, and your loved one's most needed person.

Start by considering your obligations. Besides being a care partner, what else is there? Do you have a spouse or children that need your attention too? Do you have a regular job, or volunteering responsibilities? And what about your house? Who does the housekeeping, cooking, gardening, etc., etc.? Write it all down. Don't worry about whether you can do it all right now. For now, you just need to see what it is that you feel responsible for.

Make room for you. Now make up FOUR (4) to-do lists as follows:
  • For me to do. On it write down all the things you normally do, or think you should be doing. (Warning: This list is likely going to be far too long! Far more than you can do each day. Don't worry. You can shorten it later.)
  • For others to do: Start out by writing down all the jobs that others already do. Are there any crossovers? For example, does your daughter shop for you sometimes? Now go back to your "for me" list and find more jobs that others could do. Don't worry about who. Just make a list of things others could do for you, like vacuuming the floor or doing the dishes or shopping or...well, you get the idea. Don't forget to add "sitting with loved one while I go play." This is the list you refer to when someone asks you if they can help. You can even print some out and hand one to the asker, with a "Thanks so much. Here are some ideas."
  • For me to do for myself. Write down all you can think of. This may take more effort because you aren't used to thinking about this--and because you are afraid there won't be time and so why plan on it? Don't worry. Just write them down. Now when you have some time--like when someone offers to sit with your loved one or do your dishes, you can refer to YOUR list and find an activity that will refresh you. Don't forget to add "naps!"
  • Not to do at all. Look over your "for me" list again. What is there that just really doesn't have to be done? Be ruthless. Cut out all you can! And cut down too. Instead of washing dishes after every meal, consider every day, or even less often, for example.
Join the LBD community. As the disease progresses, you will find that you have less in common with old friends, and even family. But with fellow caregivers, especially fellow LBD caregivers, you will find empathetic ears, a safe place to vent and practical caregiving tips. You may also find new friends.

Manage your own health. This could be a whole single blog in itself--but I doubt there is much here you haven't heard. Nevertheless, how much of it do you do? It is all important. Remember if you don't maintain your physical and emotional health, your body is likely to rebel and you won't have any choice--you will be the one being cared for and who knows what will happen to your loved one.

Work to eat healthy, have regular physical exercise, get enough sleep and fluids, make time for socializing and more for just being quiet, and finally see your doctor when you need to and re-fill your prescriptions.

Next week's blog will be the final one in this series.

For more information about Lewy body disorders, read our books:
A Caregivers’ Guide to Lewy Body Dementia
Managing Cognitive Issues in Parkinson's and Lewy Body Dementia
Responsive Dementia Care: Fewer Behaviors Fewer Drugs
Riding A Roller Coaster with Lewy Body Dementia: A Manual for Staff

Helen and James Whitworth are not doctors, lawyers or social workers. As informed caregivers, they share the information here for educational purposes only. It should never be used instead of a professional's advice.

Friday, October 4, 2019

2019 ILBD: Caregiver Empowerment, Pt. 2

Last week, we started a series about Angela Taylor's Four Pillars of Caregiver Empowerment. This week we move on to her Pillar 2. You, personally, have a lot more resources than you may be aware of.

You are the expert. As the care partner of someone living with LBD, you become the expert. That's true even if you weren't that close before you became their caregiver. When I became my much older sister's caregiver, I knew very little about her. We'd actually never even lived in the same town, let alone the same house. But before long, I was an expert on her needs. I had to be to do my job well. You get to know how they relate to family. You know their level of education and as time goes on, you learn what they can understand and what they can't. What they can do and can no longer do. You know their hobbies and interests, those activities that can help them still feel like the person they used to be. You know their personal preferences and idiosyncrasies, those little things that can make life miserable or happy.

Try empathy first. However, as the disease progresses and your loved one's ability to communicate diminishes, understanding their wants and needs can often be frustrating. Step back and think about what you might want if you were feeling and thinking the things your loved one is. What's going on? Are they frustrated by things they can't do anymore. Speak to the underlying feeling. Are they experiencing hallucinations or delusions? Empathy will put you in their reality, where you can relate with them rather than expecting them to relate with you in your reality--a set up for disaster! Are they confused or anxious? Try empathy laced with patience, to help them calm down. Are they depressed or apathetic? Both are LBD symptoms, all of which get worse with stress and better with relaxation.

Be realistic. Schedules, routines and rituals are a caregiver's best friends. They help your loved one feel more in control of their life. But when you set them up, take into consideration how much longer everything takes now, and how much more energy it takes as well. Be alert for tiredness and low energy levels and curtail activities if necessary. Adequate sleep is extremely important. As time goes on a person living with LBD will sleep more and more. This is normal. But so are night time wakings because their time clock doesn't work well anymore. Do your best to keep these minimal--mainly for your own need for sleep, but be realistic about their presence. It may make more sense to have someone stay at least some nights every week so you can get some sleep. Finally, as the disease progresses, personal hygiene will become less and less important to your loved one. Insist on enough to keep him acceptable and safe and let the rest go.

Find community resources.If you are fortunate, you have family members who can help you. But even then, you need to know about the resources that are available in your community. The list is long and you should start researching these well before you need them. Remember it is much easier to make informed decisions if you aren't in crisis! Check out the following: home care assistance, respite care, legal and financial services, geriatric care managers, government agencies, adult day programs and long term care choices.

Finally, don't forget about the LBDA Research Centers of Excellence. Visit www.lbda.reoe to see if there is one in your area. If so, do take advantage of what they offer:
  • Experts in clinical management of LBD. You can always find a Lewy-savvy doctor here with the latest information because the centers also provide LBD education to their health professionals.
  • Support groups and community education for you and the community.
  • Opportunities to participate in research, which can be a gratifying experience.
Next week's blog will be Pillar3: Care for Yourself. This is a subject we talk about often, but never too often, given its importance!

For more information about Lewy body disorders, read our books:
A Caregivers’ Guide to Lewy Body Dementia
Managing Cognitive Issues in Parkinson's and Lewy Body Dementia
Responsive Dementia Care: Fewer Behaviors Fewer Drugs
Riding A Roller Coaster with Lewy Body Dementia: A Manual for Staff

Helen and James Whitworth are not doctors, lawyers or social workers. As informed caregivers, they share the information here for educational purposes only. It should never be used instead of a professional's advice.

Friday, September 27, 2019

2019 ILBDC: Caregiver Empowerment, Pt.1

This week's blog starts a series about a presentation of Angela Taylor's at the 2019 International LBD Conference in Las Vegas.

These four pillars can act as a guideline to help you do the things you need to do while taking care of yourself as well. This week is all about

Pillar 1: Prepare in advance.

Knowing what you are dealing with and getting some ideas about how to do that BEFORE you need it, before it is a crisis situation, can make all the difference in the world. It is sometimes difficult to think about the future, especially when you've just received a diagnosis. However, the sooner you can do this, the easier your life is going to be later on.

Study the basics. Learn about LBD, its symptoms and how it is managed. (We have several books that can help you with that--as can many entries in this blog. Check the books out at the end of every blog entry.)

Think ahead. Get your legal and financial matters in order. If you can do this while your loved one can still legally sign papers, it will make the process much easier. Care partners also highly recommend that you hire an elder care lawyer to make sure all of these complicated tasks are done correctly and in a way so that you will get the best benefit as the disease progresses.

Prepare for doctor visits and medical emergencies by keeping a journal and having a "go bag" of things you will need in the emergency room. Make sure your loved one's living will or other health care advisories are all in order.

And think ahead about when it will be time to stop driving. Again, if this is discussed while it is an abstract issue, it will be much easier to come to an agreement. And once that agreement is in place, you will find that your loved one will be more accepting of it later (not necessarily willing, even then, but less resistant!)

Plan to adapt. This starts by accepting the diagnosis. Accepting that you life and your loved one's life will change, and will continue to change. As the disease advances, there will be role changes. You will, of necessity, take on more responsibility. Your loved one's job becomes different, not easier. It will take more and more of his effort to maintain. Think about how you will balance this major, new priority, caregiving, with your work, family and social life. Planning now, can make this much more possible. Above all, cultivate a flexible attitude. Don't get caught up in "what was." That will keep you from finding ways to adapt to the new realities.

Keep living. Don't let LBD be all there is! Continue to make new memories together. Find enjoyable things to do together and with family and friends. Empower your loved one to contribute to these memories. Maintain your connection and trust with each other. You are a team. And finally, remember to appreciate the simple pleasures of life.

Next week's blog will be Part 2 in this series about the Four Pillars of Caregiver Empowerment. Pillar #2: Use Outside Resources and Develop Your Skills.

For more information about Lewy body disorders, read our books:
A Caregivers’ Guide to Lewy Body Dementia
Managing Cognitive Issues in Parkinson's and Lewy Body Dementia
Responsive Dementia Care: Fewer Behaviors Fewer Drugs
Riding A Roller Coaster with Lewy Body Dementia: A Manual for Staff

Helen and James Whitworth are not doctors, lawyers or social workers. As informed caregivers, they share the information here for educational purposes only. It should never be used instead of a professional's advice.

Friday, September 20, 2019

2019 ILBDC: What Are Biomarkers?

This presentation at the 2019 International Lewy Body Dementia Conference by Dr. David Irwin of the University of Pennsylvania offered a thorough overview of biomarkers. He started out with this "pre-test."

A biomarker is:

a) Paper and pencil cognitive test
b) Survey/questionnaire
c) Blood test
d) Spinal fluid test
d) Physical exam finding
e) Neuroimaging
f) Sleep study- Electrophysiology
g) ALL OF THE ABOVE

Yes, the answer is "All of the above." In the past, I had thought biomarkers were mainly those expensive and involved imaging tests that physicians use improve their diagnosis things like dementia. And they are that. But it turns out that many of the things we've experienced in doctor's offices and hospitals for years can be defined as "biomarkers."

According to the National Institute of Health, a biomarker is "a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or a pharmacologic response to a therapeutic intervention."

More simply, a biomarker is anything that can be used to objectively measure an aspect of one's health or a response to treatment.

Biomarkers are used in two ways. The first is to assist in diagnosis (measure an aspect of one's health) The second is to track the progress of (a response to) an illness or its treatment.

Blood pressure is a biomarker we've used for centuries measure and track the health of our heart and circulatory system. Doctors can also use it to track the body's response to various drugs, such as those for high blood pressure. In the same way, the blood tests used to diagnose certain cancers can be used to track the body's response to treatment later.

With DLB, the type of LBD that starts before motor symptoms are evident, biomarkers are used diagnostically and as trackers.  Diagnostically, they can facilitate an earlier diagnosis. The hope is that eventually, we will be able to use biomarkers to find Lewy bodies so early that they can be eliminated before they spread. They also help the diagnosing doctor differentiate DLB from the different dementias. Biomarkers can even firm up a choice of DLB vs. Parkinson's with dementia, the "other" LBD. As trackers, they help the doctor track progression and decide upon the best treatment.

The three most used DLB biomarkers are DAT (dopamine transport) imaging, I-MIBG scanning of the heart, and sleep studies. DAT measures the movement of a protein used to move dopamine in and out of a cell. Less activity means that DLB is more likely. I-MIBG is a radio-active tracer used to measure damage to the nerves that control automatic heart function. This damage can signal the presence of LBD. Sleep studies are used to identify the presence of REM sleep behavior disorder, or active dreams.

Another biomarker that you might come into contact is a short questionnaire that a primary doctor--or even care partners!--may use to identify the presence of enough LBD symptoms that a referral to a specialist is appropriate. This may or may not include the "clock test," where a hand drawn clock is used to judge concept and hand-eye coordination.

Naturally, biomarkers are also used with Alzheimer's disease (AD). There is more and more effort on identifying AD prior to symptoms. This will likely happen before it does with LBD, but many of the same techniques can be used for other neuro-diseases such as LBD, once they have succeeded with AD.

We aren't through talking about what happened at the LBD Conference yet! Next week, we will tell you about the LBDA's Research Centers of Excellence and what they can do for you.

For more information about Lewy body disorders, read our books:
A Caregivers’ Guide to Lewy Body Dementia
Managing Cognitive Issues in Parkinson's and Lewy Body Dementia
Responsive Dementia Care: Fewer Behaviors Fewer Drugs
Riding A Roller Coaster with Lewy Body Dementia: A Manual for Staff

Helen and James Whitworth are not doctors, lawyers or social workers. As informed caregivers, they share the information here for educational purposes only. It should never be used instead of a professional's advice.

Saturday, September 14, 2019

Participating in Research: Part 2

Last week's blog was the first how of a summary of a presentation by Dan Kaufer MD, of North Carolina at the 2019 International LBD Conference. It discussed the value of and need for clinical trials and their structure, design and purposes. This week we dig a little deeper and discuss the components of clinical trials and what you should know before you participate.

Clinical Trial Components:

Institutional Review Board (IRB)
  1. Board members: doctors, researchers, members of the community
Tasks:
  • Review, approve, and monitor all clinical research studies
  • Ensure that research risks are minimized and are reasonable in relation to any potential benefits
  • Review the informed consent document to make sure it is understandable and clearly describes the risks and benefits of the study
Informed Consent

Provides potential and enrolled participants information about a clinical study
  • Intended to help a person make an informed decision about the risks of, potential benefits of, and alternatives to the study
A person must sign an informed consent document before participating in a research study
  • Signing the document and providing consent is not a contract
  • Participants may withdraw from a study at any time
Clinical Study Research Plan

A clinical study is conducted according to a research plan (protocol) that is designed to answer specific research questions and safeguard the health of participants and covers the following :
  • Reason for conducting the study
  • The number of participants needed
  • The schedule of tests, procedures, or drugs and their dosages
  • The length of the study
  • What information will be gathered about the participants
What Do You Need To Know?

Many studies have strict criteria for the study and the subjects. You need to know the following before you sign up.

Study Basics
  • What is being studied?
  • What is the therapeutic rationale for this treatment?
  • What do we know about possible treatment effects?
Subject Eligibility
  • What is the target population?
  • Inclusion criteria: age, diagnosis, severity, etc.
  • Exclusion criteria: age, severity, prohibited medications, other medical conditions, etc.
Treatment Arms (components)
  • What are the possible interventions (e.g., treatment vs. placebo) that I might receive during the trial
  • How will it be determined which intervention I receive (for example, by chance)?
  • Who will know which intervention I receive during the trial (blinding)?
Other Medications
  • Can I take my current treatment(s)?
  • Are there any medications that I am not allowed to take?
  • Are there other treatment options available?
Study Requirements
  • What will I have to do to participate?
  • Do I need to have a study partner?
  • What tests and procedures are involved?
  • How often will I have to visit the hospital or clinic?
  • Will I have to stay overnight?
  • How long will the study last?
Cost/Payments
  • Who will pay for my participation?
  • Will there be an issue with my insurance company due to experimental vs. standard care?
  • Will I be reimbursed for other expenses such as travel?
  • Who will oversee my medical care while I am participating in the trial?
  • What are my options if I am injured during the study?
Follow-Up I Termination
  • What if I decide to withdraw from the study?
  • What type of long-term follow-up care is part of this trial?
  • If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?
  • Will results of the study be provided to me? (e.g., which treatment arm, brain imaging data, genetic testing, etc.)?
Now, go find a clinical trial and join up! Just be aware that if getting a new experimental treatment is your ONLY reason for signing up, you are likely to feel cheated if you end up in the placebo group. If you look at the whole process as a way of helping the researches find out more about LBD, then getting to be in the non-placebo group can be a wonderful, but unexpected bonus to an already good adventure.

References/Resources 
Dan Kaufer MD, North Carolina
Food and Drug Administration:
Lewy Body Dementia Association
Comprehensive Clinical Trials Site
Center Watch. Overview of Clinical Trials.

For more information about Lewy body disorders, read our books:
A Caregivers’ Guide to Lewy Body Dementia
Managing Cognitive Issues in Parkinson's and Lewy Body Dementia
Responsive Dementia Care: Fewer Behaviors Fewer Drugs
Riding A Roller Coaster with Lewy Body Dementia: A Manual for Staff

Helen and James Whitworth are not doctors, lawyers or social workers. As informed caregivers, they share the information here for educational purposes only. It should never be used instead of a professional's advice.

Friday, September 6, 2019

Participating in Research: Part 1

Learning more about LBD and how to treat, or even cure takes more than researchers. It also takes people like us to step up and volunteer to be subjects. More clinical trials are ended for lack of subjects than for any other reason!  Most of the information below is from a presentation by Dan Kaufer MD, of North Carolina at the 2019 International LBD Conference.

How does clinical research differ from clinical care?
  • Clinical research involves human subjects who participate in a study protocol designed to answer a question that contributes to medical knowledge
  • Clinical trials are meant for research, not to administer proven effective medical care.
  • Clinical research is the only legitimate pathway for developing new, safe and effective treatments for a medical disorder or condition.
Types of Clinical Research Studies

Observational:
  • May be done prior to or in conjunction with a clinical trial
  • Evaluates a health-related outcome
  • Evaluating one or more tests aimed at identifying or diagnosing a particular disease or condition
Interventional:
  • Clinical trial
  • Evaluates or compares one or more therapeutic interventions for safety and potential benefits
Reasons for Conducting Clinical Studies
  • To evaluate one or more tests aimed at identifying or diagnosing a particular disease or condition
  • To explore ways to improve the comfort and quality of life through supportive care for people with a chronic illness
  • To find ways to prevent the initial development or recurrence of a disease or condition
  • To evaluate one or more interventions for treating a disease, syndrome, or condition
Drug Development Process for Human Disease

Preclinical to Clinical:
  • Average time: 12 years
  • Average cost: $1-2 billion
  • Potential treatment identified based on laboratory studies (in vitro)
  • Proof of concept studies in laboratory animal models (in vivo)
  • Human testing - clinical
Clinical Testing

Phase 1.
  • Less than 100 subjects.
  • Average time: 2 years
  • Assess safety for use in humans?
  • Usually tested in normal human subjects.
Phase 2.
  • 100 - 1000 subjects
  • Average time: 2 years
  • Assess the safety and potential effectiveness of an experimental therapy for a specific medical condition.
  • Ex: What dose or delivery method provides the highest benefit and least risk.
  • More then one Phase 2 trial exploring various aspects of a drug may run concurrently or may run consecutively, which can greatly increase the time for this phase.
Phase 3.
  • 100s - 1000s (a.k.a. "pivotal" trial)
  • Average time: 3 years
  • Typically Involves testing 1or more doses of the experimental therapy In a randomized, placebo­ controlled, double-blind study to determine If the therapy is safe and effective.
  • Randomized: Subjects are assigned by chance
  • Placebo-controlled: Subjects receive either active treatment or placebo
  • Double-blind: Assignment is not known by either the subject or investigators
Therapeutic Interventions: Regulatory Tiers
Once a therapy has passed Phase 3 Clinical Trials, it must be approved by the FDA before it can be marketed.

FDA Registered Therapies
  • Pharmaceuticals (chemically based substances)
  • Requires clinical research protocols that must meet high standards for scientific merit (e.g., double-blind, placebo-controlled), safety, and ethical conduct
  • FDA reviews data from the Phase 3 trials (and possibly others) for regulatory approval.
  • FDA approval can take over 2 years, but can be fast-tracked, with results in as little as 6 months.
Vitamins and Herbal Supplements
  • Derived from natural vs. chemical sources
  • Not intended to treat specific medical conditions 
  • Homeopathic treatments are in this category. While they are often designed to treat specific symptoms, they are not FDA governed.
  • Rigorous testing for efficacy or safety not required
  • Testing and quality control depends on company standards
Therapies for Neuro-degenerative Disorders

Symptomatic
  • Palliative
  • focus of treatment is alleviating one or more signs/symptoms associated with the disease or condition
  • potential benefit of treatment is cumulative
Disease-modifying
  • focus of treatment is to alter the underlying disease process in a way that slows down or halts progression, or reverses decline
  • potential benefit of treatment may be cumulative
Where Are Clinical Studies Conducted?

Academic research centers
  • conduct a variety of different research studies
  • perform clinical trials
  • provide clinical care
Community-based clinical trial centers
  • primary focus on performing clinical trials
  • little or no provision for clinical care
Private practices
  • primary focus is clinical care
  • also conduct clinical studies
Well, you may know a lot more about clinical trials than you did but there's more to come. I know I do! But, be sure to read next week's blog before you consider volunteering. While it is a great thing to do and much needed, you need to understand what you are getting into! Next week, the last half of this series will discuss the components of clinical trials and what you should know before you participate.

References/Resources
Dan Kaufer MD, North Carolina
Food and Drug Administration
Lewy Body Dementia Association
Comprehensive Clinical Trials Site
Center Watch. Overview of Clinical Trials.

For more information about Lewy body disorders, read our books:
A Caregivers’ Guide to Lewy Body Dementia
Managing Cognitive Issues in Parkinson's and Lewy Body Dementia
Responsive Dementia Care: Fewer Behaviors Fewer Drugs
Riding A Roller Coaster with Lewy Body Dementia: A Manual for Staff

Helen and James Whitworth are not doctors, lawyers or social workers. As informed caregivers, they share the information here for educational purposes only. It should never be used instead of a professional's advice.

Friday, August 30, 2019

2019 LBD LBD Conference: Netflamapimod, an Experimental Drug of Promise.

In April, 2019, EIP Pharma announced that they had funded a program to explore the use of neflamapimod as a treatment for DLB. Phase 2 clinical studies are expected to start this year. Ongoing Phase 2 studies trials with early Alzheimer's are expected to provide results in early fall. The drug inhibits an enzyme involved in a process that appears to increase nerve inflammation and turn a natural protein, alpha-synuclein, into toxic Lewy bodies.

Even if this new drug shows promise, it is still a long way from being available for use. Phase 2 trials can last up to two years and only about a third of experimental drugs pass these tests. In addition, drugs may undergo more than one Phase 2 trial. So far, neflamapimod has had four. Each phase of a clinical trial takes about 2 years, but as with the trials of neflamapimod for Alzheimer's, there can be more than one in each phase which may or may not run concurrently.

Netflamapimod has been in Phase 2 clinical trials for use with Alzheimer's since 2015. The four Phase 2 trials brought about enough positive reports to instigate Phase 2 trials for other diseases, including DLB, to start in 2019. If everything goes perfectly, it may be ready for FDA approval in five years--in about 2024. (2 more years for the new Phase 2 tests and 3 years for Phase 3).

FDA approval can be a long drawn out process taking 2-3 years. The FDA has been fast tracking drugs to treat serious conditions like dementia. The skipped steps do decrease the assurance of a drugs effectiveness but it can shorten the approval process by many months. Our experience is that most people living with LBD and their families would be willing to accept that danger so as to be able to try the drug sooner.

However, once the drug is on the market, it still won't be easy to get. Doctors may also hesitate to prescribe them until Phase 4 clinical trials, which occur after a drug is on the market, are complete. These Phase 4 trials test new drugs that are in public use for any problems that might have been missed in the previous trials. Even if your doctor is willing to prescribe it, insurance companies provide limited coverage for new drugs that are usually a lot more expensive than existing drugs to start with.

For more information about Lewy body disorders, read our books:
A Caregivers’ Guide to Lewy Body Dementia
Managing Cognitive Issues in Parkinson's and Lewy Body Dementia
Responsive Dementia Care: Fewer Behaviors Fewer Drugs
Riding A Roller Coaster with Lewy Body Dementia: A Manual for Staff

Helen and James Whitworth are not doctors, lawyers or social workers. As informed caregivers, they share the information here for educational purposes only. It should never be used instead of a professional's advice.