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
Accordion Pill for PD Patients with Fluctuations
This clinical trial is an approximately 32 week long study comparing the effectiveness of the Accordion Pill Carbidopa/Levodopa; AP CD/LD to the current FDA-approved Carbidopa/Levodopa. Patients eligible for this study should have a meaningful response to their PD medication and must have a total daily “OFF” time duration of ≥ 2 hours during the waking day. They should also not have any memory problems. This study has open label extension continuation (not placebo-controlled) study available for patients after completion of the initial study. For more information, please call (858) 822-MOVE or email email@example.com.
Biomarkers for PD-related cognitive problems
Dr. Joanne Hamilton in the UC San Diego Shiley-Marcos Alzheimer’s Disease Research Center (ADRC) is recruiting individuals with Parkinson’s disease-related cognitive problems and Dementia with Lewy bodies to take part in ongoing studies investigating biomarkers for and nonmotor symptoms of these diseases. Interested individuals should contact Christina Gigliotti, PhD, at 858-246-1243 for more information about these exciting opportunities.
Treatment of OFF episodes
Cynapsus Therapeutics Inc. is conducting a Phase 3 clinical study in Carlsbad on people with Parkinson’s disease to test the safety and effectiveness of a fast-acting thin film formulation of apomorphine that is absorbed under the tongue for the treatment of OFF episodes.
Patients 18 years of age or older with a clinical diagnosis of Parkinson’s disease who experience at least one well-defined OFF episode for at least two hours per waking day may be eligible to participate.
If you are interested in learning more about this study, visit https://foxtrialfinder.michaeljfox.org/trial/4154/ or contact Estela Soto by calling 760-732-0557 ext. 2123 or e-mailing firstname.lastname@example.org
Cognitive rehabilitation for people with Parkinson’s
Drs. Schiehser and Filoteo, neuropsychologists at UC San Diego, are conducting a study to evaluate if people with Parkinson’s who have cognitive impairment can benefit from a cognitive rehabilitation course. If you are interested in participating in the study, or want to learn more, call (858) 552-8585. ext. 5593.
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 email@example.com.
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.
PD and the Immune System
Dr. Litvan is collaborating with Dr. Sette at the La Jolla Allergy and Immunology (LJI) to determine if certain immune cells play a role in Parkinson’s Disease (PD). Participants will come in and be asked to provide a standard blood donation and may be asked for information regarding their medical history. Eligible patients include people diagnosed with Parkinson’s disease between the ages of 50 – 70. For more information, please call (858) 822-MOVE or email firstname.lastname@example.org.
Skin Biopsy for Familiar PD
Dr. Litvan is collecting skin biopsy of patients with Parkinson’s disease with blood relatives with pD for future PD stem cell research. For more information, please call (858) 822-MOVE or email email@example.com.
Sticker Sensor Study
Dr. Litvan is studying the applicable uses of a sticker sensor called epidermal electronic system (EES) sensor. There are three uses currently being studied:
EEG: This sub-study is studying if this sticker sensor can be used to find out more about processing in the brain. The sticker sensor will be placed on the forehead and be connected to a portable EEG to measure their brain waves while viewing visual stimulus on a computer screen and/or listening to auditory stimulus. Patients may be asked to take this system home and complete fifteen minutes of testing a day for a week.
EMG: Prior studies have demonstrated a hyperactivation of a laryngeal muscle at rest in patients with PD with needle-based EMG. This sub-study is determining if this EES sticker sensor and standard transcutaneous EMG electrodes can replicate this study in a non-invasive manner. During this study, the sticker sensor will be placed on the skin to record muscle activation while the subject is making different phonations.
EGG: This sub-study is studying if this sticker sensor can be used to monitor the GI tract non-invasively. The sticker sensors will be placed on your abdomen and will monitor your GI tract while you stay sitting for up to four hours for each recording.
For more information, please call (858) 822-MOVE or email firstname.lastname@example.org.
Using MRI to study cognitive changes
Dr. Deborah Harrington’s lab uses functional and structural magnetic resonance imaging to study the neural bases for cognitive changes in Parkinson’s disease. The goal is to identify early signatures of dysfunction in brain networks that support cognition and to explore individual differences in the risk for cognitive decline. If you are interested in participating or would like to refer a potential volunteer, please contact Dr. Harrington’s research coordinator at 858-642-6392. Link to Dr. Harrington’s publications.
Validation of new MDS PD Diagnostic Criteria
This study is validating a new PD criteria. All patients with a diagnosis of Parkinsonism without dementia are eligible. During this study, the patient will be asked to complete a scratch and sniff test, answer a few additional questions and allow a movement disorder fellow evaluate their medical record. For more information, please call (858) 822-MOVE or email email@example.com.