Molecular and Functional Imaging of Parkinson's Pathology in SNCA, Parkin and PINK1 Mutation Carriers

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

In this study, the investigators aim to 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 PD symptoms.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 80
View:

• All subjects must be judged by the investigator able to understand the nature, design, and procedures of the study and must be able to provide a signed and dated informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.

• All subjects must be willing and able to comply with scheduled visits, required study procedures and laboratory tests.

• All subjects must be able to travel to the research sites for the study procedures.

• For female subjects: They must be either of non-childbearing potential (either surgically sterile or post- menopausal - defined as 12 months of spontaneous amenorrhea), or, if of childbearing potential, subjects must demonstrate to be non-pregnant (as demonstrated by negative urine β-HCG test at screening), non-breastfeeding.

• All subjects must comply with highly effective contraceptive measures. A highly effective contraceptive measure is defined as a measure that can achieve a failure rate of less than 1% per year when used consistently and correctly. These methods are listed in more detail below:

⁃ Oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation;

⁃ Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation:

⁃ Intrauterine device (IUD)

⁃ Intrauterine hormone-releasing system (IUS)

⁃ Bilateral tubal occlusion

⁃ Vasectomised partner

⁃ Sexual abstinence

• For sexually active male subjects, they 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. They must also 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.

• \*\*All subjects must have adequate visual and auditory acuity according to investigator's judgement to complete the psychological testing.

• All subjects must have no use of medications with known interaction with serotonergic transmission (e.g. selective serotonin reuptake inhibitors, tricyclic antidepressant, triptans, etc).

• For subjects taking any drugs that might interfere with dopamine transporter SPECT imaging (neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative) must be willing and able from a medical standpoint to hold the medication for at least 5 half-lives prior to screening DaTSCANä imaging.

Locations
Other Locations
United Kingdom
University Of Exeter
RECRUITING
Exeter
Contact Information
Primary
Marios Politis, Professor
m.politis@exeter.ac.uk
07503 741242
Backup
Edoardo de Natale, Dr
e.de-natale@exeter.ac.uk
07503 741242
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 45
Treatments
SNCA (Alpha-synuclein gene)
PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology.
Parkin (Parkin gene)
PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology
PINK1 (Phosphatase and Tensin Homolog (PTEN)-Induced Kinase 1 gene)
PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology
GBA1 (Glucosylceramidase beta gene)
Symptomatic and asymptomatic heterozygous carriers of risk variants to the GBA1 gene for Parkinson's disease
Related Therapeutic Areas
Sponsors
Leads: University of Exeter

This content was sourced from clinicaltrials.gov