Serotonin Release in Premotor and Motor PD

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25-85
SponsorUniversity of Exeter

About this trial

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

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Positron Emission Tomography (PET) scan using CIMBI-36 tracer
  • Magnetic Resonance Imaging (MRI) Scan
  • Positron Emission Tomography (PET) scan using DASB tracer
  • FP-CIT Single-photon Emission Computed Tomography (SPECT) scan
  • Lumbar puncture

Treatment groups

42 Participants
are divided into 2 treatment groups

Sponsors and collaborators