Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
40 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Neuron23 Inc. · Industry
Who this trial is looking for
This trial is looking for men and women aged 40-80 who have early Parkinson's Disease and a specific genetic profile. Participants will take part in a study to evaluate the safety and effectiveness of a new treatment called NEU-411.
Are You a Good Fit for This Trial?
You may be able to join if
I am 40-80 years old
I have early Parkinson's Disease
I have a genetic profile indicating LRRK2-driven Parkinson's Disease
I have a modified Hoehn and Yahr score of 1 to 2.5
You may not be able to join if
I have secondary or atypical parkinsonian syndromes
I have uncontrolled diabetes
I have significant medical conditions that my doctor finds concerning
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 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.
Trial Locations
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Eligibility Criteria
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
Exclusi…
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.
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