NCT05516732 Serotonin Release in Premotor and Motor PD
| NCT ID | NCT05516732 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Exeter |
| Condition | Parkinson Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 42 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 42 participants in total. It began in 2022-07-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion criteria- * Subjects must understand the nature of the study and must provide signed and dated written HRA-approved informed consent in accordance with local regulations before any protocol-specific screening procedures are performed; * Males and females, age 25-85 years, inclusive; * Women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative β-hCG test at screening. For sexually active subjects (except females of non-childbearing potential-e.g., at least 2 years postmenopausal or surgically sterile), condoms should be used in addition to other birth control methods for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. These patients must be willing to remain on their current form of contraception for the duration of the study. All male subjects must agree to refrain from donating sperm for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. Sexually active male subjects must agree to use condoms to protect their partners from becoming pregnant for the duration of the study and for 3 months after the last administration of PET or SPECT ligands (i.e. for 15 consecutive months following baseline PET and SPECT scans); agree to ensure that they and their partners are routinely using a medically approved contraceptive method. It is important that male subjects not impregnate others for the duration of the study and for 3 months after the last administration of PET or SPECT ligands; * Able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures; * Adequate visual and auditory acuity to complete the psychological testing; * In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study. Exclusion criteria - * Subjects lacking capacity according to investigator judgement; * Subjects taking serotonin acting drugs such as antidepressants (i.e. tricyclic or selective serotonin reuptake inhibitors etc.); * Pregnancy or breastfeeding or intent to become pregnant in the next 18 months; * Subjects with current or a recent history of drug or alcohol abuse/dependence; * Subjects who have other neurological disorders and known intracranial co-morbidities such as stroke, hemorrhage, space-occupying lesions; * Presence of any clinically significant medical condition (including cardiovascular, respiratory, cerebrovascular, hematological, hepatic, renal, gastrointestinal, or other disease) that, based on the judgment of the investigator, is clinically unstable, is likely to deteriorate during the course of the study, could put the patient at risk because of participation in the study, could affect the subject's ability to complete the study, or could influence the study results; * History of suicidal behaviour or active suicidal ideation; * Within 1 year prior to screen or between screen and baseline (Day -1), any of the following: myocardial infarction; hospitalization for congestive heart failure; hospitalization for, or symptoms of, unstable angina; or syncope not related to PD; * History or presence of renal disease or impaired renal function; * Clinically important infection (e.g., chronic, persistent, or acute infection) within 30 days prior to screen or between screen and baseline (Day -1); * History of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma of the skin; * Clinically significant blood clotting or bleeding disorder, including clinically significant abnormal findings in laboratory assessments of coagulation or hematology; * Use of antipsychotic medication within 3 months prior to screen or between screen and baseline (Day -1); * Use of any anticoagulant within 30 days prior to baseline and follow-up PET scans; * Use of any oral corticosteroid within 30 days prior to baseline and follow-up PET scans; * Use of metoclopramide within 30 days prior to baseline and follow-up (Day -1); * Use of any thyroid medication within 30 days prior to baseline and follow-up (Day -1); * Regular use (e.g., taken \> 3 days/week) of narcotic pain medications within 30 days prior to baseline and follow-up (Day -1); * Presence of any of the following MRI contraindications: pacemaker; cardiac defibrillator; spinal cord or vagus nerve stimulator; aneurysm clip; artificial heart valve; recent coronary or carotid stent; ear implant; CSF shunt; other implanted medical device (e.g., Swan-Ganz catheter, insulin pump); or metal fragments or foreign objects in the eyes, skin, or body; * Negative modified Allen test in both hands, unless the brachial artery is used for arterial cannulation; * Claustrophobia or history of back pain that makes prolonged laying on the PET or MRI scanner intolerable; * History of severe skin allergy; * Patients who had previous surgery for PD (including but not limited to deep brain stimulation \[DBS\] or cell transplantation); * Patients who are treated with duodopa or apomorphine; * Initiation or change in pharmacologic therapy for symptoms of PD within 30 days prior to screen or between screen and baseline and follow-up (Day -1). * GDS score greater than or equal to 10 (GDS score of 5 - 9 requires Investigator discretion to enter study). * STAI Form Y-1 greater than or equal to 54 requires Investigator discretion to enter study.
Contact & Investigator
Marios M Politis, Professor
PRINCIPAL INVESTIGATOR
University of Exeter
Frequently Asked Questions
Who can join the NCT05516732 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 85 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05516732 currently recruiting?
Yes, NCT05516732 is actively recruiting participants. Contact the research team at M.Politis@exeter.ac.uk for enrollment information.
Where is the NCT05516732 trial being conducted?
This trial is being conducted at Exeter, United Kingdom.
Who is sponsoring the NCT05516732 clinical trial?
NCT05516732 is sponsored by University of Exeter. The principal investigator is Marios M Politis, Professor at University of Exeter. The trial plans to enroll 42 participants.
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