RECRUITING

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

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

Conditions

Parkinson DiseaseParkinsonIdiopathic Parkinson DiseaseEarly Parkinson Disease (Early PD)Parkinson Disease, Idiopathic
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Related Conditions:

Parkinson DiseaseParkinsonIdiopathic Parkinson DiseaseEarly Parkinson Disease (Early PD)Parkinson Disease, Idiopathic

Study Overview

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Study Details

Study overview

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

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

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

Condition
Parkinson Disease
Intervention / Treatment

-

Contacts and Locations

Sun City

Banner Sun Health Research Institute, Sun City, Arizona, United States, 85351

Little Rock

University of Arkansas, Little Rock, Arkansas, United States, 72205

Fresno

Neuro-Pain Medical Center, Fresno, California, United States, 93710

Irvine

University of California, Irvine, Irvine, California, United States, 92697

Los Angeles

University of California, Los Angeles, Los Angeles, California, United States, 90095

Murrieta

Esperanza Clinical, Murrieta, California, United States, 92562

Palo Alto

Parkinson's Research Centers of America - Palo Alto, Palo Alto, California, United States, 94301

Aurora

University of Colorado - Anschutz Medical Campus, Aurora, Colorado, United States, 80045

New Haven

Invicro, New Haven, Connecticut, United States, 06510

Boca Raton

Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida, United States, 33486

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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
  • 1. 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)

Ages Eligible for Study

40 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Neuron23 Inc.,

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

Study Record Dates

2027-09