If you have Parkinson’s, you may be asked to volunteer for a research study. Deciding whether or not to sign up is an important decision. Learning about research studies can help you decide if being a volunteer is right for you.
What is a research study?
Research studies are done when doctors and scientists want to find new ways of treating an illness. Research studies are often called clinical trials. Most Parkinson’s studies focus on new medicines. Others focus on treatments such as surgery.
Why are research studies important?
Research studies are important because they help discover new treatments. They are done to make sure that new medicines are safe and that they work. Research studies couldn’t be done without volunteers. People who volunteer for research studies make new treatments possible.
Why should I sign up for a research study?
You may be able to get new treatments before they are available to the public.
You will receive expert health care, usually at no charge.
You are helping to find new treatments, which will help others who get Parkinson’s.
What questions should I ask?
Before you decide to sign up, you should learn as much as you can about the research study. The research team should be approachable so you feel comfortable asking these important questions:
1.) Does the study test a new drug or piece of equipment?
2.) Do I have a chance of getting a pill that isn’t the study drug?
3.) Why is the study being done?
4.) How long will the study last?
5.) Where will I have to go for study visits?
6.) How many visits will I need to make?
7.) What tests and treatments will I take part in?
8.) Who will be in charge of my care?
9.) Are there other treatments that might help?
10.) What are the risks?
11.) What are the benefits?
12.) Who is paying for study treatments?
13.) What are my rights as a volunteer?
14.) Will my study information be shared with others?
15.) Will I have to pay for treatment?
What are the risks?
There are also risks when you sign up for a research study. Some medical tests or side effects may be uncomfortable, and the treatment may not help your Parkinson’s.
What happens if I decide to volunteer?
If you decide to volunteer, you must sign an informed consent form. The form includes answers to all of the questions above. You should read the form closely and ask any questions that have not been answered to your satisfaction. If you do sign the consent form, you still can withdraw from the study at any time.
Important terminology :
As you look into research studies, you may come across jargon unfamiliar to you.
IRB (Institutional Review Board): The IRB is a group of doctors, health care professionals, and members of the community. The IRB reviews the study plan and informed consent from to make sure that the safety and rights of the volunteers are protected. Every research study must be approved by an IRB.
FDA (Food and Drug Administration): The FDA is the government office that makes sure that all drugs and medical devices are safe and helpful.
Protocol: The protocol is the study plan. The protocol describes what types of people can volunteer, how long the study will last, and what will take place during the research study. The protocol is designed to protect the volunteers’ safety throughout the study.
Placebo: A placebo is a pill that doesn’t have any medicine in it. It looks like a drug, but causes no changes in the body. Some research studies will compare the new treatment with a placebo.
Phase of Study: All drugs and treatments go through different phases of research before they are approved. Most studies that you may sign up for will be Phase 2 or Phase 3 studies.
Phase 1 Study: Phase 1 studies are usually done with healthy volunteers. The new treatment is tested in a small group of 20-80 people to look for side effects and judge safety.
Phase 2 Study: Phase 2 studies are done with a larger group of people who have the target illness, such as Parkinson’s. The goal of Phase 2 research is to test how well the new treatment works, and to gather more information about side effects and safety.
Phase 3 Study: Phase 3 studies are done with a larger group of at least 500 people. Phase 3 testing compares the new treatment with similar treatments that are already approved.
Study Design: There are several different designs, or methods, for research studies. Here are three common designs:
- Placebo-controlled studies are those in which some people get a pill without any medicine in it.
- Single-blind, placebo-controlled studies are those in which either the study patient or the researcher does not know if the patient is receiving the actual study drug or a placebo.
- Double-blind, placebo-controlled studies are those in which neither the study patient nor the researcher knows if the patient is getting the study drug or a placebo. Double-blind studies are thought to be the best study design.
It’s always wise to speak with your doctor prior to participating in any research study.
STUDIES CURRENTLY RECRUITING PARTICIPANTS
Excessive Daytime Sleepiness and Diagnosed with Idiopathic PD
We are conducting a 9-week, double blind study. We are specifically looking for adults between 35 – 80 years of age at the start of the study. We are seeking study patients who suffers from excessive daytime sleepiness and has a diagnosis of idiopathic PD.
The first/screening visit, our physician (Dr. Roy Artal) will provide a thorough physical examination to assess if participants are eligible. If patients would like to participate, they will return to our clinic 30 days later and subsequently, all participants will come back in once a week for 5 weeks. So it will be a total of 7 clinic visits. All study participants will be provided compensation for transportation, any overnight stays and for each clinic visit.
The benefits of this medication is that the effects appear to last throughout the day without the effects of amphetamines like in other current medications on the market and more importantly, it does not produce rebound hypersomnia.
For more information contact Shelena Young, at email@example.com or by phone: (310) 657-1230 x130
Creation of Stem Cells from Patients with Familial PD
The UCSD Movement Disorder Center is conducting a study to learn more about the Genetics of familial Parkinson disease by using skin cells from affected individuals to be transformed into pluripotent stem cells and ultimately into neurons genetically identical to patients. We are currently seeking volunteers with either a known genetic mutation of Parkinson’s disease (e.g., LRRK2) and/or have a known family history of Parkinson’s disease. Non-UCSD patients will first need to be seen by a UCSD Movement Disorder Specialist to confirm the diagnosis and medical history. Participation will include a single skin biopsy and blood draw at our offices in La Jolla. For more information, please call (858) 822-MOVE or email firstname.lastname@example.org.
Dr. Michael P. Caligiuri kinematic research studies of handwriting movements to identify writer-based sources of variability in signature authentication in movement disorders and dementia for forensic applications. Please contact Christina Gigliotti, PhD, at 858-246-1243 for more information about these exciting opportunities.
Pre-Parkinson’s Progression Markers Initiative (Pre-PPMI)
The Parkinson’s Progression Markers Initiative (PPMI) is a landmark observational study designed to help define biomarkers, or indicators of Parkinson’s disease (PD) progression. PPMI has added a new arm to the existing study that will investigate certain risk factors of PD. By better understanding risk factors, such as smell loss, doctors may be able to identify people with Parkinson’s before the onset of motor symptoms. Early detection is a crucial step in understanding the causes of PD and developing better treatments for Parkinson’s disease.
The task of identifying risk factors for PD offers friends and family of people with Parkinson’s a unique role to play in Parkinson’s research. People who are over the age of 60 and who do not have Parkinson’s are needed for this study that will assess the relationship between Parkinson’s and sense of smell. Find out if you are eligible to participate by taking this smell survey or call (877) 525-PPMI. If you have Parkinson’s disease, we need your help to reach the 10,000 people without PD who may qualify. Invite family and friends to follow their noses to research that could make a difference for Parkinson’s research. UC San Diego is a site for this research study, and you may also contact Christina Gigliotti, Ph.D. at 858-246-1243 for additional information.
Parkinson’s Disease and its connection to the immune system
La Jolla Institute’s professor Dr. Sette, together with his collaborators at Columbia University, have linked autoimmunity to Parkinson’s disease. Published in Nature, their study found that T cells can be tricked into thinking dopamine neurons are foreign by the buildup of damaged alpha-synuclein proteins, a key feature of Parkinson’s disease.
For more information on joining this research study, email email@example.com. Or call/text us at (858)255-0680 or visit lji.org/study. CLICK HERE for more information on the study. CLICK HERE for more information on the research and press release.