Evaluation of [18F]FD4 PET targeting alpha synuclein in Parkinson Disease and Multiple System Atrophy
FD4 is a new investigational radiotracer or imaging agent that binds to abnormal alpha synuclein, a brain protein that is abnormal in diseases like Parkinson’s Disease and Multiple System Atrophy (MSA). The purpose of this research to see how well FD4 can bind to abnormal alpha synuclein protein in the brain of people with and without Parkinson’s disease and MSA.
Link to enroll: www.redcap.link/more-info
Disclaimer: This research opportunity is not affiliated with NAF. We are sharing this information as a resource for the Ataxia community. Sharing this information does not imply endorsement by NAF.
About the Study
Eligible Ataxia Types
Multiple System Atrophy (MSA)
Type of Study
Interventional Trial
Clinical Trial Phase
Phase 1
Age Range
40+
Study Start Date
08/24/2026
Estimated Completion Date
02/28/2027
IRB Approval #
WCG IRB Protocol #20253544
Location(s)
The Institute for Neurodegenerative Disorders
55 Church Street, 7th Floor
New Haven, CT
Contact Information
What does participation in the study entail?
If you choose to take part in this study, you will be asked to sign this consent form. You will be asked to complete up to a total of two (2) visits for this study, a Screening, a Baseline visit, and a brief follow-up phone call. The Screening and Baseline visits will each take approximately 6-8 hours to complete.
Screening Visit is used to confirm your eligibility and ensure it is safe for you to participate in this study and study procedures. Screening tests may include the following:review consent form, review of your medical and neurological history, including diagnosis of MSA, review current and past medications, physical and neurological examinations, vital signs, blood tests, urine tests, review of existing brain imaging and ordering MRI and DaTscan additional imaging if needed to confirm your diagnosis and assess the involved brain systems. Screening also includes a lumbar puncture to confirm positive CSF for alpha-synuclein.
Baseline PET Imaging using the FD4 imaging tracer: You will complete a PET brain imaging scan using the NeuroEXPLORER (NX) camera. Imaging may last up to approximately 3 hours.
What are the potential benefits/risks for participants?
There will be no direct benefit to you from participating in this research study; however, you will undergo medical assessments with a study doctor who specializes in MSA. This study may generate information that can lead to a better understanding of the disease process and may lead to improvement in medical care.
- Risks include:
Some of the questions you will be answering are personal and about your health condition. This may make you feel uncomfortable, anxious or upset. You do not have to answer questions you do not feel comfortable answering. You may feel tired or frustrated when completing some of the study activities. - The insertion of the IV may cause pain or a stinging feeling or may leave a bruise. Sometimes people can feel lightheaded or even faint after a blood draw. Rarely, an injury to a blood vessel or nerve could occur. You will need to lie very still under the camera for up to 180 minutes, which may cause back pain, headache, dizziness or feeling tired.
- Risks of blood draw: Blood draws may cause pain and bruising at the site where the blood is taken.
- Risks of [18F] FD4: [18F]FD4 is an investigational imaging agent that contains a small amount of radiation. The amount of radiation you will receive from the [18F]FD4 PET scan is similar to what you would get naturally over 3 years by simply living on the earth
Risks of Lumbar Puncture (LP):
- The lumbar puncture may cause pain at the site where the needle goes in, and the spinal fluid is taken. There is a risk of infection or bleeding. Sometimes people can feel lightheaded or even faint during or after a procedure. After the lumbar puncture, you may get a headache. To minimize the risk of a headache, the doctor will use a thin needle and may prescribe bedrest for one or more hours after the procedure. If a headache occurs, it is usually mild and can be controlled by bedrest, drinking lots of fluids, caffeinated drinks, or a pain pill, such as Tylenol.
Is there financial compensation?
Up to $300 for completing screening and PET scan
Is there travel reimbursement?
Hotel, mileage, other transportation as needed
Who is eligible?
To be eligible for this study, participants meet the following criteria:
- Male or Female 40 years of age and older with a clinical Dx of Multiple System Atrophy
Clinically established MSA or Clinically Probable MSA according to the Movement Disorder Society Criteria for the Diagnosis of Multiple System Atrophy - Positive CSF α-syn SAA
- An abnormal DATscan