Rebalance neurotransmitter precursors with supplement
- Trial ID
- NCT07115563
- Official Title
- Effects of Targeted Amino Acid Supplementation for People With Parkinson's Disease on Amino Acid Profiles and Health Related Markers
- Goal
- Rebalance neurotransmitter precursors with supplement
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Cristina Colon-Semenza
- Study Type
- INTERVENTIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson Disease (PD)
- Interventions
- Targeted Amino Acid Supplement, Control (placebo)
Summary For Families
The goal is to find out whether a targeted blend of amino acids can change blood amino acid profiles and related health markers in people with Parkinson's, which might influence neurotransmitter balance and overall metabolism. The approach gives a daily supplement of selected amino acids versus placebo, aiming to boost or rebalance precursors for neurotransmitters and protein synthesis, and the study will watch for interactions with levodopa because some amino acids can compete with it for transport into the brain. Participants should be age 60 to 80 with idiopathic Parkinson's, on dopamine replacement therapy like levodopa for at least two years and on a stable dose for three months, with exclusions for significant cognitive impairment, deep brain stimulation, bleeding disorders, or other unstable medical issues.
Locations
- University of Connecticut, Storrs, Connecticut, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Targeted Amino Acid Supplement. The goal is to find out whether a targeted blend of amino acids can change blood amino acid profiles and related health markers in people with Parkinson's, which might influence neurotransmitter balance and overall metabolism. The approach gives a daily supplement of selected amino acids versus placebo, aiming to boost or rebalance precursors for neurotransmitters and protein synthesis, and the study will watch for interactions with levodopa because some amino acids can compete with it for transport into the brain. Participants should be age 60 to 80 with idiopathic Parkinson's, on dopamine replacement therapy like levodopa for at least two years and on a stable dose for three months, with exclusions for significant cognitive impairment, deep brain stimulation, bleeding disorders, or other unstable medical issues.
- Who can participate?
- Participants must be between 60 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 10 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.