A Phase 2 Study of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Purpose
The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 50-80 years with early Parkinson's Disease (PD) who have predicted elevations in the activity of the "leucine-rich repeat kinase 2" ("LRRK2" for short) pathway based on their genetic profile. A DNA test will be used to identify the "LRRK2-driven" population with predicted elevation in the LRRK2 pathway. Participants will: • Take NEU-411 or placebo every day for 52 weeks
Conditions
- Parkinson Disease
- Parkinson
- Idiopathic Parkinson Disease
- Early Parkinson Disease (Early PD)
- Parkinson Disease, Idiopathic
Eligibility
- Eligible Ages
- Between 50 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Aged 50-80 years at time of screening, inclusive 2. Diagnosis of clinically established or clinically probable Parkinson's Disease (PD) 3. LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx) 4. Modified Hoehn and Yahr (mH&Y) of 1 to 2.5
Exclusion Criteria
- Secondary or atypical parkinsonian syndromes 2. Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) >8% 3. Other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening) Additional inclusion and exclusion criteria are outlined in the full study protocol.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- The Sponsor is also masked.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NEU-411 |
Orally-administered NEU-411 |
|
|
Placebo Comparator Placebo |
Orally-administered matching placebo |
|
Recruiting Locations
Sun City, Arizona 85351
Fresno, California 93710
Irvine, California 92697
Boca Raton, Florida 33486
Tampa, Florida 33613
Chicago, Illinois 60611
Kansas City, Kansas 66160
Lexington, Kentucky 40536
Boston, Massachusetts 02215
Farmington Hills, Michigan 48334
Golden Valley, Minnesota 55427
Chapel Hill, North Carolina 27599
Columbus, Ohio 43210
Round Rock, Texas 78681
Kirkland, Washington 98034
More Details
- NCT ID
- NCT06680830
- Status
- Recruiting
- Sponsor
- Neuron23 Inc.
Detailed Description
NEU-411-PD201 is a Phase 2, randomized, placebo-controlled, proof-of-concept study in participants with early Parkinson's Disease (PD) who have LRRK2-driven PD as measured by an investigational companion diagnostic genetic test (CDx). The study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NEU-411, an orally-administered, potent, selective, bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity as compared to placebo. After participants are screened for inclusion in the study, approximately 150 participants will be randomized in a 1:1 allocation ratio to NEU-411 30 mg once per day or placebo for a 52-week treatment period. A safety follow-up visit will occur 2 weeks after the last treatment visit.