NCT05558787|Completed
AADC/TDC in Advanced Parkinson's Disease
AADCTDC
Aromatic L-amino Acid Decarboxylase Activity, Tyrosine Decarboxylase Activity and Gut Microbiome in Patients With Advanced Parkinson's Disease
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AADCTDC
Aromatic L-amino Acid Decarboxylase Activity, Tyrosine Decarboxylase Activity and Gut Microbiome in Patients With Advanced Parkinson's Disease
Sponsor study identifier
observational
48
1 country
1
Study Start
June 28, 2023
Actual (reported)Primary Completion
August 14, 2024
Actual (reported)Study Completion
August 14, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 14, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 9, 2022
Actual (reported)September 28, 2022
Actual (reported)June 28, 2023
Actual (reported)August 14, 2024
Actual (reported)August 14, 2024
Actual (reported)Prevalence of increased TDC activity in feces
through study completion, an average of 2 weeks
Prevalence of increased AADC activity in serum
through study completion, an average of 2 weeks
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
through study completion, an average of 2 weeks
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV
through study completion, an average of 2 weeks
Timed up-and-go test
through study completion, an average of 2 weeks
Purdue Pegboard Test
through study completion, an average of 2 weeks
Composite Clinical Motor Score
through study completion, an average of 2 weeks
50 adult patients with Parkinson's disease (diagnosed by a neurologist), with a disease duration of at least 5 years (since diagnosis).
Radboudumc Centre of Expertise for Parkinson & Movement Disorders
Nijmegen, 6525 GC, Netherlands
Feces, serum, urine
48 participants (actual enrollment reported by the registry).
First Submitted
September 9, 2022
First Posted
September 28, 2022
Study Start
June 28, 2023
Actual (reported)The Effect of Compensation Strategies on Gait Impairment in Parkinson's Disease
Contact the study team to confirm eligibility.
Primary Completion
August 14, 2024
Actual (reported)Study Completion
August 14, 2024
Actual (reported)Last Updated
August 19, 2024
Record last verified: 2024-08
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Source: ClinicalTrials.gov.
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