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 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

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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 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

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

Farmington Hills

Quest Research Institute, Farmington Hills, Michigan, United States, 48334

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 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
  • 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

50 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