- Determines a safe dose and identifies initial side effects of an investigational drug
- 20 to 100 healthy volunteers or patients
Learn more about alpha-synuclein
and the investigational drug.
Clinical research studies play an important part in the development of medical treatments. They are conducted to test investigational drugs to determine if they may be safe and effective treatment options for use in the future.
When people are interested in joining a clinical study, they will typically need to answer a few questions to see if a particular study is right for them. To begin with, researchers will see if a person who is interested in participating meets some initial requirements.
Participation in a clinical research study is always voluntary. If you decide to participate, you may withdraw at any time and for any reason. If you decide not to participate, your decision will not affect the care you are receiving now or may receive in the future.
To better understand the investigational drug, many studies require that researchers randomly assign patients (like flipping a coin) to receive either the investigational drug or a placebo. A placebo is an inactive substance that is designed to look like the investigational drug but has no effect on health.
The SPARK study is for people who have been recently diagnosed with Parkinson’s disease and are looking to take a proactive step in their care. We are evaluating an investigational drug to see if it may offer patients a way to potentially treat Parkinson’s disease in its earliest stages.
For the SPARK study, you may be eligible to participate if you:
If you are eligible and decide to take part in the SPARK study, you will undergo a series of medical tests and procedures that may include:
Blood and Urine Samples
Participants’ blood and urine samples will be used to evaluate how the participant’s body processes the investigational drug, in addition to other routine tests.
Electrocardiogram (ECG) Test
An ECG is a test that measures and records the electrical impulses from a person’s heart.
This is a procedure where doctors draw fluid from a space at the base of the spinal cord (in the lower back) using a thin needle. Only one third of participants will undergo lumbar punctures throughout study participation.
Magnetic Resonance Imaging (MRI)
This scan allows medical personnel to check the internal structures of a person’s body (like nerves and the brain).
Mental and Psychological Assessments
Study staff will ask patients to complete tests, interviews, and questionnaires so they can monitor your mental and psychological health throughout the study.
Parkinson’s Disease Assessments
The study staff will conduct a series of tests and assessments to monitor Parkinson’s disease symptoms.
Single-photon Emission Computed Tomography (SPECT) and DaTscan
These combined scans allow doctors to capture detailed images and information about chemical reactions in a person's brain.
Site Telephone Calls
Participants will occasionally be asked to speak with study staff on the telephone to review any changes in health or medications throughout the study.
All eligible study participants will receive at no cost:
Getting to and from study visits should not prevent you from joining the SPARK study. Speak with a member of the study staff to see if you may be eligible for our travel assistance program.
Our patient reimbursement program ensures study participants are quickly reimbursed for any study-related expenses (gas, public transportation, parking, meals) while attending study visits.