Targeted Amino Acid Supplement for Parkinson's (NCT07115563)
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 50 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 10 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- 3 in-person lab visits — at baseline, after 3 months, and after 6 months — over a total of 6 months.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.