Gastrointestinal Dopamine Decarboxylase and Levodopa Pharmacokinetics
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- No age limits stated
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "They will also undergo a baseline blood draw (5.5 mLs) through an indwelling venous cannula in the antecubital vein."
- "Repeat blood samples will be collected immediately after oral levodopa ingestion (T=0) and then repeated every ½ hour until T=4 hours for a total of 10 draws, including the baseline."
- "Blood samples will be centrifuged to separate plasma and immediately frozen at -80oC until analysis by an investigator blinded to which study group the patient belongs."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at whether an enzyme in the stomach that breaks down levodopa affects how much medicine the body takes in, stomach and gut symptoms, and movement control. It is for people with Parkinson's disease who take dopamine replacement medicine and have already had stomach tissue samples taken during a needed medical test.
The main treatment for Parkinson's disease is a medication called levodopa. Levodopa has to be absorbed from the gut and travel to the brain to work, but a naturally occurring enzyme in the lining of the stomach, called dopamine decarboxylase (AADC), can break some of it down before it ever reaches the brain. We do not yet know whether people whose stomachs have more of this enzyme absorb less of their levodopa dose, have worsened gastrointestinal (GI) symptoms associated with levodopa intake, and whether that affects how well the medication controls their movement symptoms. This research may help doctors understand why levodopa works better in some people with Parkinson's disease than others, which could help improve treatment in future.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have Parkinson's disease.
- Previously had stomach tissue samples taken during an EGD—a test that uses a camera to look inside the upper gut—for a medical reason.
- Currently take dopamine replacement medicine, such as levodopa.
Who can't join
- Have no history of Parkinson's disease.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Parkinson's disease * Gastric biopsies previously obtained during clinically-indicated EGD procedure * Taking dopamine replacement therapy currently Exclusion Criteria: * No history of Parkinson's disease
Study sites (1)
MA
- Beth Israel Deaconess Medical Center · Boston, MA 02215Louise Halbert, BA · Study contact · 6176670698 · lhalbert@bidmc.harvard.eduTrisha Pasricha, MD, MPH · Study contact · 6176670161 · tpasrich@Bidmc.harvard.eduTrisha S Pasricha, MD, MPH · Principal investigatorMore trials in Boston