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

This trial does not accept healthy volunteers

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 population

A cohort of carriers of genetic mutations for familial forms of Parkinson's Disease, Idiopathic Parkinson's Disease patients, and previously collected data from healthy controls

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Positron Emission Tomography (PET) scan using CIMBI-36 tracer

    Other intervention

    This scan creates images of regional serotonin release in by using a tracer compound called CIMBI to highlight the brains capacity to release serotonin.

  • Magnetic Resonance Imaging (MRI) Scan

    Other intervention

    MRI (magnetic resonance imaging) uses magnets alongside radio waves to create pictures of the brain

  • Positron Emission Tomography (PET) scan using DASB tracer

    Other intervention

    To create images of the brain using a tracer called DASB, which is a highly selective for serotonin transporters, this highlights serotonin terminals and neurons in the brain.

  • FP-CIT Single-photon Emission Computed Tomography (SPECT) scan

    Other intervention

    A single-photon emission computerized tomography (SPECT) scan allows analysis of brain function by creating 3D Pictures using compounds called tracers.

  • Lumbar puncture

    Other intervention

    A lumbar puncture invovles a thin needle is inserted between the bones in your lower spine using local anaesthetic. This allows the collection of Cerebrospinal fluid ( CSF)

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: SNCA (Alpha-synuclein gene)5 interventions
Group B: Idiopathic Parkinson's Disease5 interventions

Trial outcomes

Primary outcomes

1

DASB (a marker of Serotonin transporter) used to quantify in vivo pathology of serotonin

To quantify serotonergic pathology with \[11C\]3-amino-4-(2- imethylaminomethylphenylsulfanyl)-benzonitrile (DASB) Positron Emission Tomography (PET)

Time frame
3 Weeks
2

SPECT to measure brain molecular pathology

To quantify serotonergic pathology with \[11C\]DASB PET and dopaminergic pathology with Single-photon Emission Computed Tomography (SPECT)

Time frame
3 Weeks
3

Magnetic Resonance Imaging (MRI)

Magnetic Resonance Imaging (MRI) to view structural and microstructural changes and structural connectivity.

Time frame
3 Weeks
4

CIMBI to measure serotonin release

CIMBI-36 can be interpreted to show serotonin release capacity both quantifiably and locational.

Time frame
3 weeks

Secondary outcomes

Other outcomes

1

Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) To determine if there is a correlation with neuropsychological and behavioural evaluation.

A rating tool used to gauge the course of Parkinson's disease in patients

Time frame
3 Weeks
2

Montreal Cognitive Assessment (MOCA) to determine if there is a correlation with neuropsychological and behavioural evaluation

A cognitive screening test designed to assist in the detection of mild cognitive impairment. Scored out of 30.

Time frame
3 Weeks
3

Cambridge Neuropsychological Test Automated Battery (CANTAB) to determine if there is a correlation with neuropsychological and behavioural evaluation

Administered to detect cognitive issues \& brain disorders efficiently.

Time frame
3 Weeks
4

Symbol Digit Modalities Test (SDMT) to determine if there is a correlation with neuropsychological and behavioural evaluation

To be used in screening for organic cerebral dysfunction sored out of 110

Time frame
3 Weeks

Sponsors and contacts

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