---
title: Relate genetic changes to mood
nct_id: NCT05518617
status: RECRUITING
sponsor: University of Exeter
study_type: OBSERVATIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT05518617"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05518617"
last_fetched: "2026-05-10T14:01:48.916Z"
source: "Parkinson's Pathways (curated)"
---
# Relate genetic changes to mood

**Goal (in five words):** Relate genetic changes to mood

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

**Trial ID:** [NCT05518617](https://clinicaltrials.gov/study/NCT05518617)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Sponsor:** University of Exeter
- **Target Enrollment:** 45 participants
- **Start Date:** 2022-07-01
- **Completion Date:** 2026-06-30
- **Conditions:** Parkinson Disease, Nervous System Disorder, Neurodegenerative Diseases, Neurodegenerative Disease, Hereditary, Parkinson's
- **Interventions:** Positron Emission Tomography (PET) scan using DASB tracer
- **Intervention Types:** OTHER

## Summary For Families

They want to map brain changes tied to hereditary Parkinson's genes SNCA, Parkin, and PINK1, to learn how these mutations affect non-dopaminergic systems that can drive symptoms like mood, sleep, and thinking. Participants have a PET scan with the DASB tracer, which binds the serotonin transporter so researchers can measure serotonergic nerve terminal health; the protocol also ties those images to MRI, dopamine SPECT, and spinal fluid measures, and it is observational so it does not change your Parkinson's medications. The study is looking for adults 25 to 80 who carry those mutations (or matched controls) who can tolerate PET and MRI and a lumbar puncture, are not taking serotonergic drugs like SSRIs, and do not have dementia, MRI contraindications, or bleeding risks.

## Eligibility

- **Minimum age:** 25 Years
- **Maximum age:** 80 Years
- **Sex:** ALL

### Full 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.
```

## Locations (1)

- University Of Exeter, Exeter, Devon, United Kingdom _(50.7236, -3.5275)_
  - Marios Politis, Professor — (CONTACT) — 07503 741242 — m.politis@exeter.ac.uk
  - Edoardo de Natale, Dr — (CONTACT) — 07503 741242 — e.de-natale@exeter.ac.uk

## Central Contacts

- Marios Politis, Professor — (CONTACT) — 07503 741242 — m.politis@exeter.ac.uk
- Edoardo de Natale, Dr — (CONTACT) — 07503 741242 — e.de-natale@exeter.ac.uk

---

*Canonical: https://parkinsonspathways.com/trial/NCT05518617*  
*HTML version: https://parkinsonspathways.com/trial/NCT05518617*  
*Source data: https://clinicaltrials.gov/study/NCT05518617*