Printed from Voxsanity (voxsanity.com.au) — NCT07685444 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Early Phase 1 Parkinson's Disease Trial, Not Yet Recruiting
NCT07685444
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People aged 30 to 70 years (inclusive), of any gender.
- People who fully understand the study's purpose, procedures, and possible side effects, and who are willing to sign a consent form to take part voluntarily.
- People who have been clinically diagnosed with idiopathic Parkinson's disease (Parkinson's disease with no known external cause) according to recognised 2015 diagnostic guidelines.
- People who carry at least one harmful change (variant) in a gene called GBA1.
- People who have had Parkinson's disease for 3 years or longer.
- People whose Parkinson's disease severity, measured when off their medication, falls within a specific range on a scale called the Hoehn-Yahr scale (stage 2.5 to 4).
- People whose blood test shows a low enough level of neutralising antibodies against a substance called AAV (a level of 1:200 or lower).
- People whose Parkinson's motor symptoms, measured when off medication, score above 25 on a standard assessment scale, and who also either respond well enough to a levodopa test dose or experience sufficient daily "off" time (periods when their medication is not working well).
- People who have been on a stable dose of Parkinson's medications, including levodopa, for at least 4 weeks before surgery, as determined by the trial doctors.
- People whose blood test results during the screening period fall within acceptable ranges for red blood cells, platelets, liver function, and kidney function (confirm with trial site for specific values).
- People who are able to attend scheduled follow-up visits and keep a Parkinson's disease diary during the study, or who have a family member, legal guardian, or carer who can help with this.
- People who agree to delay any other planned elective brain surgery, including Deep Brain Stimulation (DBS), until at least 52 weeks after joining the trial, unless a specialist recommends DBS as being in the person's best interest.
- People who agree not to join any other treatment studies or take medications that might interfere with the trial treatment during the study period.
- People who agree not to receive any vaccinations in the 30 days following surgery.
- People who are willing to permanently refrain from donating blood, organs, tissues, or cells after receiving the trial treatment.
- Female participants who could potentially become pregnant must have a negative pregnancy test before joining.
- People (and their partners) who do not plan to conceive from the screening stage through to 6 months after the study ends, and who agree to use effective contraception; participants must also agree not to donate sperm or eggs during this time.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have an atypical or secondary form of parkinsonism, such as Parkinson-plus syndromes, inherited forms of parkinsonism, or parkinsonism caused by medication.
- People who have a confirmed mutation in a gene called LRRK2.
- People who have previously had brain surgery, including pallidotomy, Deep Brain Stimulation (DBS), striatal surgery, or stereotactic brain surgery, or any other surgery that the trial doctors believe would interfere with participation.
- People whose previous brain CT or MRI scans have shown conditions such as brain injury, abnormal blood vessels, fluid build-up in the brain, brain tumours, signs of bleeding risk, blood vessel damage, or other abnormalities in brain regions that would significantly increase surgical risk.
- People who score below 20 on a standard memory and thinking assessment called the Mini-Mental State Examination (MMSE).
- People whose score on a depression questionnaire (PHQ) is 16 or higher, indicating severe depression.
- People who have serious psychiatric conditions such as epilepsy, severe anxiety, or schizophrenia that the trial doctors consider unsuitable for participation (mild hallucinations caused by Parkinson's medications are not automatically excluded).
- People taking blood-thinning or antiplatelet medications whose blood clotting has not returned to normal within 10 days of stopping those medications.
- People who have previously received gene therapy or cell therapy of any kind.
- People who have used systemic steroids (glucocorticoids) or immune-suppressing drugs within the 12 weeks before the trial treatment is given, except for any preventive immune-suppressing treatment required by the trial protocol.
- People with unstable heart or blood vessel conditions, including a heart attack, stroke, or unstable chest pain in the 3 months before screening; uncontrolled diabetes with a blood sugar marker (HbA1c) above 8.0%; or other serious uncontrolled conditions including severe uncontrolled high blood pressure or severe drops in blood pressure when standing up.
- People who test positive for Hepatitis B, Hepatitis C, HIV, or syphilis (specific rules apply for people with a past history of hepatitis B or C — confirm with trial site).
- People who have conditions or recent surgeries that make brain surgery unsafe or unsuitable, as determined by the trial doctors.
- People whose average weekly alcohol intake exceeds 21 units (for males) or 14 units (for females) in the 30 days before screening, or people with a history of drug dependence.
- People who are allergic to contrast dye used in MRI scans, unable to undergo MRI, or unable to tolerate surgical anaesthesia.
- People who have a known allergy or sensitivity to the trial treatment, LY-N001 Injection.
- People who have had cancer within the 5 years before screening, with some exceptions for certain fully treated, non-spreading cancers (confirm with trial site for details).
- People who are pregnant, planning to become pregnant, or currently breastfeeding.
- People who are currently enrolled in another clinical trial, or who received an investigational treatment in another trial within the past month.
- People who the trial investigators determine are not suitable for enrolment for any other reason.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.
Contact this trial
Principal Investigator: Yi Wang, PhD, The First Affiliated Hospital of Anhui Medical University
Phone: +8619121572057
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Early Phase 1
Sponsor
Lingyi Biotech Co., Ltd.
Registry
ClinicalTrials.gov
Start date
7 July 2026
Est. completion
7 July 2028
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Incidence of dose-limiting toxicity (DLT) events occurring within at least 28 days following a single intracranial administration of LY-N001; Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) occurring during the treatment period
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.