A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Status: Recruiting
Location: See all (44) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
University of Arkansas
RECRUITING
Little Rock
Arizona
Banner Sun Health Research Institute
RECRUITING
Sun City
California
Neuro-Pain Medical Center
RECRUITING
Fresno
University of California, Irvine
RECRUITING
Irvine
University of California, Los Angeles
RECRUITING
Los Angeles
Esperanza Clinical
NOT_YET_RECRUITING
Murrieta
Parkinson's Research Centers of America - Palo Alto
NOT_YET_RECRUITING
Palo Alto
Colorado
University of Colorado - Anschutz Medical Campus
RECRUITING
Aurora
Connecticut
Invicro
NOT_YET_RECRUITING
New Haven
Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
RECRUITING
Boca Raton
University of Florida
RECRUITING
Gainesville
Neurology One
RECRUITING
Orlando
USF Parkinson's & Movement Disorders Clinic
RECRUITING
Tampa
Georgia
Emory University
RECRUITING
Atlanta
Augusta University
RECRUITING
Augusta
Illinois
Northwestern Medical Group, Department of Neurology
RECRUITING
Chicago
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Kentucky
University of Kentucky
RECRUITING
Lexington
Louisiana
Ochsner Clinic Foundation
NOT_YET_RECRUITING
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Maryland
University of Maryland
NOT_YET_RECRUITING
Baltimore
Michigan
Quest Research Institute
RECRUITING
Farmington Hills
Minnesota
Struthers Parkinson Center
RECRUITING
Golden Valley
North Carolina
University of North Carolina - Chapel Hill
RECRUITING
Chapel Hill
Velocity Clinical Research at Raleigh Neurology
NOT_YET_RECRUITING
Raleigh
Nevada
Cleveland Clinic
RECRUITING
Las Vegas
New York
Northwell Health
RECRUITING
Great Neck
Columbia University
RECRUITING
New York
Icahn School of Medicine at Mount Sinai/Mount Sinai West
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
Ohio
The Ohio State University
RECRUITING
Columbus
Oklahoma
The Movement Disorder Clinic of Oklahoma
RECRUITING
Tulsa
Oregon
Oregon Health & Science University (OHSU)
RECRUITING
Portland
Pennsylvania
Thomas Jefferson University Hospital
NOT_YET_RECRUITING
Philadelphia
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Vanderbilt University
RECRUITING
Nashville
Texas
Neurology Consultants of Dallas PA
NOT_YET_RECRUITING
Dallas
Baylor College of Medicine
RECRUITING
Houston
The University of Texas Health Science Center at Houston
NOT_YET_RECRUITING
Houston
Central Texas Neurology Consultants
RECRUITING
Round Rock
Utah
University of Utah Movement Division
RECRUITING
Salt Lake City
Virginia
University of Virginia
RECRUITING
Charlottesville
Washington
EvergreenHealth
RECRUITING
Kirkland
Wisconsin
Medical College of Wisconsin
NOT_YET_RECRUITING
Milwaukee
Contact Information
Primary
Fatta B Nahab, MD, FAAN, FANA
clinicaltrials@neuron23.com
650-228-2527
Time Frame
Start Date: 2025-01-17
Estimated Completion Date: 2027-09
Participants
Target number of participants: 150
Treatments
Experimental: NEU-411
Orally-administered NEU-411
Placebo_comparator: Placebo
Orally-administered matching placebo
Related Therapeutic Areas
Sponsors
Leads: Neuron23 Inc.
Collaborators: Qiagen Manchester Limited, Roche Diagnostic Ltd.