JPRN-jRCT2033210696
Recruiting
Phase 1
Phase I/II Study of Gene Therapy for Parkinson's disease
akajima Takeshi0 sites12 target enrollmentMarch 26, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- akajima Takeshi
- Enrollment
- 12
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients diagnosed with Parkinson's disease by MDS Clinical Diagnostic Criteria for Parkinson's Disease.
- •\-Patients aged 40 to 75 years at the time of obtaining informed consent.
- •\-Patients onset of an illness\> 35 years of age.
- •\-Patients who have received L\-dopa for at least 5 years.
- •\-Patients whose severity of Hoehn \& Yahr in the OFF state at the time of informed consent was IV.
- •\-Patients with a baseline total MDS\-UPDRS\-III score (OFF) of 30 to 100\.
- •\-Patients who have a clear response to L\-dopa and have improved MDS\-UPDRS\-III by at least 16 points at baseline ON and OFF.
- •\-Untolerable motor complications in patients with a total score of at least 4 on MDS\-UPDRS\-IV at baseline (motor fluctuations) who fail to respond satisfactorily to appropriate drug therapy.
- •\-Patients who can undergo stereotactic brain surgery.
- •\-Patients who do not need dosage changes for the Parkinson's Disease treatment for at least 8 weeks, prior to the start of the study substance administration.
Exclusion Criteria
- •\-Patients with a history of cerebrovascular disease, exposure to antipsychotics or toxins, encephalitis, symptoms such as progressive supranuclear palsy or cerebellar symptoms, pyramidal signs, autonomic signs, dementia, hallucinations or delusions, or MRI findings such as lachner infarction or atrophy of the midbrain tegment, pons and cerebellum suggesting secondary or atypical parkinsonism.
- •\-Patients who have already undergone stereotactic neurosurgery (pallidal coagulation, thalamic coagulation, deep brain stimulation) and MR\-guided focused ultrasound therapy for Parkinson's disease.
- •\-Patients with a Mini\-Mental State Examination (MMSE) score of 20 or less or with a diagnosis of dementia.
- •\-Patients with a history of schizophrenia or affective disorders.
- •\-Patients with apparent vascular diseases, including cerebrovascular disorders.
- •\-Patients with neoplastic disease of the central nervous system, clinically evident neurological disease (e.g., age\-inappropriate, obvious brain atrophy).
- •\-Patients with a concomitant malignancy or a history of other malignancies other than previously treated skin cancers within 5 years before obtaining informed consent.
- •\-Patients with uncontrolled hypertension.
- •\-Patients with coagulopathy or who require antithrombotic therapy.
- •\-Patients with clinically prominent evidence of immunodeficiency who require immunosuppressant treatments excluding steroid therapy.
Outcomes
Primary Outcomes
Not specified
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