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 40-80 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 40 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Aged 40-80 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 5316201, Arizona 5551752 85351
Little Rock 4119403, Arkansas 4099753 72205
Fresno 5350937, California 5332921 93710
Irvine 5359777, California 5332921 92697
Los Angeles 5368361, California 5332921 90095
Aurora 5412347, Colorado 5417618 80045
Boca Raton 4148411, Florida 4155751 33486
Gainesville 4156404, Florida 4155751 32608
Orlando 4167147, Florida 4155751 32825
Tampa 4174757, Florida 4155751 33613
Atlanta 4180439, Georgia 4197000 30329
Augusta 4180531, Georgia 4197000 30912
Chicago 4887398, Illinois 4896861 60611
Kansas City 4273837, Kansas 4273857 66160
Lexington 4297983, Kentucky 6254925 40536
Boston 4930956, Massachusetts 6254926 02215
Farmington Hills 4992523, Michigan 5001836 48334
Golden Valley 5028163, Minnesota 5037779 55427
Las Vegas 5506956, Nevada 5509151 89106
Great Neck 5119218, New York 5128638 11021
New York 5128581, New York 5128638 10032
Rochester 5134086, New York 5128638 14618
Chapel Hill 4460162, North Carolina 4482348 27599
Columbus 4509177, Ohio 5165418 43210
Tulsa 4553433, Oklahoma 4544379 74136
Portland 5746545, Oregon 5744337 97239
Charleston 4574324, South Carolina 4597040 29425
Round Rock 4724129, Texas 4736286 78681
Charlottesville 4752031, Virginia 6254928 22903
Kirkland 5799841, Washington 5815135 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.