Radboudumc Centre of Expertise for Parkinson & Movement Disorders
Nijmegen, 6525 GC, Netherlands
NCT Number: NCT05558787
Rationale: Many persons with Parkinson's disease (PD) develop a progressive resistance to levodopa, which is the pharmacological mainstay of PD treatment. Recently, two enzymatic pathways have been identified that could be (partially) responsible for this: 1) breakdown of levodopa by bacterial tyrosine decarboxylase (TDC), an enzyme which normally decarboxylates dietary tyrosine but which is also able to decarboxylate levodopa. Accumulation of bacterial TDC in the small intestine, such as in the context of small-intestinal bacterial overgrowth (SIBO) - for which persons with PD are at increased risk - has the potential to prematurely metabolize levodopa, hence limiting its bioavailability and effect. 2) paradoxical induction of activity of the enzyme aromatic L-amino acid decarboxylase (AADC) in chronic users of levodopa combined with a peripheral decarboxylase inhibitor, also leading to a premature breakdown of levodopa and limitation of its bioavailability and effect.
Primary objective: in a cross-sectional sample of advanced (≥5 years) Parkinson's disease determining the prevalence of increased bacterial TDC activity in feces, and the prevalence of increased AADC activity in serum.
Secondary objective: correlating these biomarkers to clinical parameters, correlating composition of the microbiome to TDC activity, to the presence of levodopa resistance, and to factors related to socio-economic status.
Study design: using feces, serum and urine samples and clinical data from n=50 participants, the relevant enzymes' activity will be measured and the composition of the gut microbiome will be determined. These will be correlated to the clinical and demographic parameters.
Looking for future studies?
Notify Me25 year and older
All sexes
Observational
Nijmegen, 6525 GC, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: through study completion, an average of 2 weeks
Time frame: through study completion, an average of 2 weeks
Time frame: through study completion, an average of 2 weeks
Baseline score and score after levodopa administration
Time frame: through study completion, an average of 2 weeks
Baseline score and score after levodopa administration
Time frame: through study completion, an average of 2 weeks
TUG. Baseline score and score after levodopa administration
Time frame: through study completion, an average of 2 weeks
Baseline score and score after levodopa administration
Time frame: through study completion, an average of 2 weeks
This is a composite of MDS-UPDRS-III, TUG and pegboard test scores. Baseline score and score after levodopa administration.
Time frame: through study completion, an average of 2 weeks
Ordinal scale of Parkinson's disease severity. Baseline score and score after levodopa administration.
Time frame: through study completion, an average of 2 weeks
Questionnaire on wearing-off symptoms
Time frame: through study completion, an average of 2 weeks
15-item scale on gastrointestinal symptoms associated with small-intestinal bacterial overgrowth (SIBO)
Time frame: through study completion, an average of 2 weeks
Single-question scale on the ability to perform activities of daily living
Time frame: through study completion, an average of 2 weeks
9-item questionnaire on (current and past) medication use for Parkinson's disease, and their effect on symptoms
Time frame: through study completion, an average of 2 weeks
14-item questionnaire on demographic parameters
Time frame: through study completion, an average of 2 weeks
18-item questionnaire on diet
Time frame: through study completion, an average of 2 weeks
Catechol-O-methyltransferase
Radboud University Medical Center
Other
Aromatic L-amino Acid Decarboxylase Activity, Tyrosine Decarboxylase Activity and Gut Microbiome in Patients With Advanced Parkinson's Disease
Acronym: AADCTDC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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