RECRUITING

A Phase 2 Study of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease

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Conditions

Parkinson DiseaseParkinsonIdiopathic Parkinson DiseaseEarly Parkinson Disease (Early PD)Parkinson Disease, IdiopathicEarly PDParkinsonsParkinsons DiseaseIdiopathic Parkinsons Diseaseleucine-rich repeat kinase 2PDNEULARKLRRK2

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-01-17
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06680830

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Aged 40-80 years at time of screening, inclusive
  2. 2. Diagnosis of clinically established or clinically probable Parkinson's Disease (PD)
  3. 3. LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx)
  4. 4. Modified Hoehn and Yahr (mH\&Y) of 1 to 2.5
  1. 1. Secondary or atypical parkinsonian syndromes
  2. 2. Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) \>8%
  3. 3. Other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening)

Contacts and Locations

Study Contact

Fatta B Nahab, MD, FAAN, FANA
CONTACT
650-228-2527
clinicaltrials@neuron23.com

Principal Investigator

Fatta B Nahab, MD, FAAN FANA
PRINCIPAL_INVESTIGATOR
Neuron23 Inc.

Study Locations (Sites)

Banner Sun Health Research Institute
Sun City, Arizona, 85351
United States
University of Arkansas
Little Rock, Arkansas, 72205
United States
Neuro-Pain Medical Center
Fresno, California, 93710
United States
University of California, Irvine
Irvine, California, 92697
United States
University of California, Los Angeles
Los Angeles, California, 90095
United States
Esperanza Clinical
Murrieta, California, 92562
United States
Parkinson's Research Centers of America - Palo Alto
Palo Alto, California, 94301
United States
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Invicro
New Haven, Connecticut, 06510
United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
United States
University of Florida
Gainesville, Florida, 32608
United States
Neurology One
Orlando, Florida, 32825
United States
USF Parkinson's & Movement Disorders Clinic
Tampa, Florida, 33613
United States
Emory University
Atlanta, Georgia, 30329
United States
Augusta University
Augusta, Georgia, 30912
United States
Northwestern Medical Group, Department of Neurology
Chicago, Illinois, 60611
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
University of Kentucky
Lexington, Kentucky, 40536
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
University of Maryland
Baltimore, Maryland, 21201
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Quest Research Institute
Farmington Hills, Michigan, 48334
United States
Struthers Parkinson Center
Golden Valley, Minnesota, 55427
United States
Cleveland Clinic
Las Vegas, Nevada, 89106
United States
Northwell Health
Great Neck, New York, 11021
United States
Icahn School of Medicine at Mount Sinai/Mount Sinai West
New York, New York, 10019
United States
Columbia University
New York, New York, 10032
United States
University of Rochester
Rochester, New York, 14618
United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Velocity Clinical Research at Raleigh Neurology
Raleigh, North Carolina, 27607
United States
The Ohio State University
Columbus, Ohio, 43210
United States
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, 74136
United States
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Vanderbilt University
Nashville, Tennessee, 37232
United States
Neurology Consultants of Dallas PA
Dallas, Texas, 75243
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
Central Texas Neurology Consultants
Round Rock, Texas, 78681
United States
University of Utah Movement Division
Salt Lake City, Utah, 84108
United States
University of Virginia
Charlottesville, Virginia, 22903
United States
EvergreenHealth
Kirkland, Washington, 98034
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Neuron23 Inc.

  • Fatta B Nahab, MD, FAAN FANA, PRINCIPAL_INVESTIGATOR, Neuron23 Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-17
Study Completion Date2027-09

Study Record Updates

Study Start Date2025-01-17
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

  • Early PD
  • Parkinsons
  • Parkinsons Disease
  • Idiopathic Parkinsons Disease
  • leucine-rich repeat kinase 2
  • PD
  • NEULARK
  • LRRK2

Additional Relevant MeSH Terms

  • Parkinson Disease
  • Parkinson
  • Idiopathic Parkinson Disease
  • Early Parkinson Disease (Early PD)
  • Parkinson Disease, Idiopathic