Molecular and Functional Imaging in Monogenic PD.

Launched by UNIVERSITY OF EXETER · Aug 24, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring new ways to understand Parkinson's disease, a condition that affects movement and can lead to significant challenges over time. The researchers are using advanced imaging techniques, including PET scans, SPECT scans, and MRI, to look for specific markers in the brain that could reveal how Parkinson's disease progresses. The ultimate goal is to help develop new medications that might slow down the symptoms of the disease, potentially improving the quality of life for those affected.

To participate in this study, individuals must be able to understand the study's purpose and procedures and provide consent. They should be willing to attend scheduled visits and comply with the study's requirements. Eligible participants include both men and women aged between 18 and 80 who do not have certain medical conditions that could interfere with the study. Throughout the trial, participants can expect to undergo imaging scans and possibly some tests that help researchers learn more about their condition. It's important to know that participants will need to follow specific guidelines regarding medications and contraception during the study to ensure their safety and the accuracy of the results.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Subjects lacking capacity according to investigator judgement.
• • Subjects with a clinical diagnosis of dementia as determined by the investigator.
• • Current treatment with anticoagulants (e.g. warfarin, heparin) that might preclude safe completion of the lumbar puncture.
• • Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
• • Use of any of the following drugs that might interfere with dopamine transporter SPECT imaging: neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 5 months of Screening.
• • Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
• • History of cancer within the last 5 years, with the exception of non-metastatic basal cell carcinoma of the skin.
• • Subjects with current or recent history of drug or alcohol abuse/dependence.
• • Contraindication to MRI, such as presence of metal devises or implants (e.g. pacemaker, vascular- or heart- valves, stents, clips), metal deposited in the body (e.g. bullets or shells), or metal grains in the eyes;
• • Claustrophobia or history of back pain that makes prolonged laying on the PET or MRI scanner intolerable.
• • Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
• • Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.