Parkinson Disease study: NEU-411
Official title A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
ClinicalTrials.gov ID: NCT06680830
What this study is testing
What is NEU-411?
NEU-411 is an investigational medicine, taken by mouth, being studied as a potential treatment for parkinson disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if the drug NEU-411 is safe and effective for treating early Parkinson's disease in people whose genes suggest a specific biological pathway is overactive.
- Who it's for
- Men and women aged 40 to 80 with early Parkinson's disease who have a specific genetic profile indicating high activity in the LRRK2 pathway.
- What's involved
- Participants will take the study drug NEU-411 and undergo a DNA test to confirm their genetic profile. They will also have regular check-ups to monitor their health and how the drug is working.
- Time commitment
- The study includes a main testing phase followed by an open-label extension, but the specific total duration and visit schedule are not listed in the provided text.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- Aged 40-80 years at time of screening, inclusive
- Diagnosis of clinically established or clinically probable Parkinson's Disease (PD)
- LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx)
- Modified Hoehn and Yahr (mH\&Y) of 1 to 2.5
You likely can't join if
- Secondary or atypical parkinsonian syndromes
- Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) \>8%
- Other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening) Additional inclusion...
The study team makes the final eligibility decision.
Where it is enrolling
- Sun City, Arizona, United States
- Little Rock, Arkansas, United States
- Fresno, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Sacramento, California, United States
- Aurora, Colorado, United States
- Boca Raton, Florida, United States
- Gainesville, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Lexington, Kentucky, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
+ 44 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Sun City, Arizona, United States; Little Rock, Arkansas, United States; Fresno, California, United States; Irvine, California, United States; Los Angeles, California, United States; Palo Alto, California, United States and 58 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.