Actively Recruiting
Serotonin Release in Premotor and Motor PD
Led by University of Exeter · Updated on 2025-10-07
42
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study, the investigators aim to provide a deeper understanding of Parkinson's disease and find a biomarker of Parkinson's disease. This is done using imaging scans called Positron Emission tomography (PET), Single Photon Emission Computed Tomography (SPECT), and Magnetic Resonance Imaging (MRI). The findings will provide a deeper understanding of the brain changes in Parkinson's disease. More importantly, this study will help with the discovery and development of new medications aiming to delay progression of Parkinson's disease symptoms
CONDITIONS
Official Title
Serotonin Release in Premotor and Motor PD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and provide signed informed consent before any screening
- Male or female, aged 25 to 85 years inclusive
- Women of childbearing potential must use approved contraception and have a negative pregnancy test at screening
- Sexually active participants must agree to use condoms and approved birth control methods during the study and for 3 months after last PET or SPECT scans
- Male participants must agree not to donate sperm and to use condoms with partners during the study and for 3 months after last PET or SPECT scans
- Able and willing to participate in all evaluations, follow study restrictions, and complete all tests and procedures
- Adequate vision and hearing to complete psychological testing
- Investigator considers participant likely to comply with protocol and complete the study
You will not qualify if you...
- Lacking capacity to consent as judged by investigator
- Taking serotonin-acting drugs such as antidepressants
- Pregnant, breastfeeding, or intending pregnancy within 18 months
- Current or recent history of drug or alcohol abuse or dependence
- Other neurological disorders or brain co-morbidities like stroke or hemorrhage
- Clinically significant unstable medical conditions that could affect safety or study completion
- History of suicidal behavior or active suicidal thoughts
- Recent serious heart events within 1 year before screening
- History or presence of kidney disease or impaired renal function
- Significant infections within 30 days before screening
- History of cancer in last 5 years except nonmetastatic basal cell skin carcinoma
- Blood clotting or bleeding disorders
- Use of antipsychotics within 3 months before screening
- Use of anticoagulants, oral corticosteroids, metoclopramide, thyroid medication, or regular narcotic pain meds within 30 days prior to baseline and follow-up
- MRI contraindications such as pacemaker, implanted devices, metal fragments, or claustrophobia
- Negative modified Allen test in both hands unless brachial artery used
- History of severe skin allergy
- Prior PD surgery including deep brain stimulation or cell transplantation
- Treatment with duodopa or apomorphine
- Changes in PD medication within 30 days prior to screening and baseline
- GDS score 10 or higher, or STAI Form Y-1 score 54 or higher unless investigator discretion allows
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Of Exeter
Exeter, Devon, United Kingdom, EX1 2LU
Actively Recruiting
Research Team
M
Marios Politis, Professor
CONTACT
E
Edoardo De Natale, Dr
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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