Investigating NEU-411 for Early Parkinson's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 clinical trial aims to evaluate the efficacy and safety of NEU-411 in individuals aged 50-80 with early Parkinson's Disease who have elevated activity in the LRRK2 pathway, identified through a genetic test. Participants will be randomly assigned to receive either NEU-411 or a placebo daily for 52 weeks. The study will assess various outcomes, including the drug's pharmacokinetics and pharmacodynamics, compared to placebo. A follow-up visit will occur two weeks after the treatment period to monitor safety.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

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)

Additional inclusion and exclusion criteria for the RCP and OLE are outlined in the full study protocol.

Where it's running

• Banner Sun Health Research Institute
  Sun City, Arizona, United States Recruiting
• University of Arkansas
  Little Rock, Arkansas, United States Recruiting
• Neuro-Pain Medical Center
  Fresno, California, United States Recruiting
• University of California, Irvine
  Irvine, California, United States Recruiting
• University of California, Los Angeles
  Los Angeles, California, United States Recruiting
• Parkinson's Research Centers of America - Palo Alto
  Palo Alto, California, United States Recruiting

+22 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Fatta B Nahab, MD, FAAN FANA — Neuron23 Inc.
• Study coordinator: Fatta B Nahab, MD, FAAN, FANA
• Email: clinicaltrials@neuron23.com
• Phone: 650-228-2527

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mediterranean diet for people with Parkinson's disease

  This study will try a Mediterranean diet to see if it helps motor and non-motor symptoms in people with Parkinson's disease.

  Recruiting Università degli Studi dell'Insubria · Varese, Varese · NCT06705517

• Gut methane and Parkinson's: measuring if a probiotic helps people with Parkinson's, REM sleep behavior disorder, or cognitive concerns

  This study tests whether a probiotic containing Limosilactobacillus reuteri can help people with Parkinson's disease, those at high risk for PD, and related cognitive issues by potentially improving gut methane levels and overall symptoms.

  Recruiting University of Cambridge · Cambridge, CB2 · NCT07786116

• Detecting Parkinson's-related alpha-synuclein in colon tissue taken during routine colonoscopy

  This will see if small extra colon tissue samples taken during a routine colonoscopy can find phosphorylated alpha-synuclein in people with Parkinson's disease or REM sleep behavior disorder.

  Recruiting CND Life Sciences · Branford, Connecticut · NCT07217054

• Detecting phosphorylated alpha-synuclein in colon tissue to help diagnose Parkinson's

  This study will test whether routine colonoscopy tissue samples from adults with Parkinson's show phosphorylated alpha-synuclein, a protein linked to the disease.

  Recruiting CND Life Sciences · Portland, Oregon · NCT07204652

• Community walking program for people with Parkinson's disease

  This study tests a 6-month walking program for people with Parkinson's disease and their caregivers to see if it helps them stay active and connected with others.

  Recruiting St. Louis University · St Louis, Missouri · NCT06859528

• One-day exercise test to see how brain and body react in epilepsy, cognitive disorders, Parkinson's, dementia, and related conditions

  A one-day study tests how an acute bout of exercise changes brain function and bodily signals in people with certain neurological conditions compared with healthy individuals.

  Recruiting Brigham and Women's Hospital · Boston, Massachusetts · NCT07883720

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.