Aromatic L-amino acid decarboxylase activity, tyrosine decarboxylase activity and gut microbiome in patients with advanced Parkinson*s disease

Recruiting

• Conditions: idiopathic parkinsonism; Parkinson's disease; 10025477; 10028037

• Registration Number: NL-OMON51457
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

- Subject has Parkinson*s disease of at least 5 years duration, defined as time
since diagnosis made by a neurologist;
- Subject is an adult, at least 25 years of age;
- Subject can read and understand Dutch;
- Subject has completed the METC-approved Informed Consent;
- Subject is willing, competent, and able to comply with all aspects of the
protocol,
including not taking their PD medication during a 12-hour period, and
biospecimen collection.

Exclusion Criteria

- Co-morbidities that would hamper interpretation of parkinsonian
disability, such as coincident musculoskeletal abnormalities, as judged by the
investigators;
- Significant doubt over the correctness of the diagnosis PD, as judged by the
investigators;
- Not able to stand or walk without the assistance of another person (walking
aids are not an exclusion criterion);
- Never having used levodopa;
- No current use of levodopa due to lack of effect, despite never having used
at least 600mg/day during at least 1 month;
- Documented allergy or contraindication to either levodopa or benserazide;
- Documented severe and debilitating dyskinesias on levodopa, to such an extent
that levodopa treatment was terminated;
- Current pregnancy or breastfeeding;
- Co-morbidity with primary gastrointestinal pathology associated with altered
gut microbiota and/or altered absorption (such as inflammatory bowel disease,
celiac disease, colorectal carcinoma);
- Antibiotic use at any time during the 12 months leading up to the clinic
visit;
- Current or recent (less than 1 month before clinic visit) use of
(non-parkinson) drugs known or suspected to influence AADC activity, including
amphetamine, dexamethasone, dopamine receptor antagonists, monoamine oxidase
(MAO) inhibitors (including MAO-B inhibitors which are infrequently used as
antiparkinsonian drugs), prostaglandin E2, and vigabatrin.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Prevalence of increased TDC activity in faeces and increased AADC activity in<br /><br>serum.</p><br>