A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease (J-REGENERATE-PD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AB-1005.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: 45 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Open-label, Single Group, Fixed-dose Study to Evaluate the Safety and Efficacy of a Single Bilateral Intraputaminal Administration of AB-1005 (AAV2-GDNF Gene Therapy) in Japanese Participants With Moderate Stage Parkinson's Disease
Overview
The objective of this Phase 2, open-label, single group, one-time, fixed-dose study is to assess the safety and efficacy of bilateral intraputaminal infusion of AB-1005 (AAV2-GDNF gene therapy) in Japanese patients with moderate Parkinson's Disease (PD).
Interventions
- Drug AB-1005
Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
Primary outcome measures
- Incidence of adverse events up to Month 18 after study intervention [Time frame: Up to 18 months]
- Change from Baseline to Month 18 in normalized Good ON time measured with PD Motor Diary [Time frame: Up to 18 months]
Eligibility criteria
Inclusion criteria
- Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent
- Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) and currently meeting all the following criteria:
- Presence of bradykinesia PLUS any of the following: rigidity, rest tremor, postural instability
- Presence of motor fluctuations as measured by the PD Motor Diary
- Stable anti-parkinsonian medication regimen for 4 weeks or more, prior to screening
- Responsiveness to levodopa therapy
Exclusion criteria
- Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis
- Presence or history of significant vascular and/or cardiovascular disease
- Presence of clinically significant cognitive impairment
- Presence or history of psychosis or impulse control disorder
- History of malignancy other than treated cutaneous squamous or basal cell carcinomas
- Presence of clinically relevant conditions that could compromise surgical suitability and/or subject safety
- Contraindication to magnetic resonance imaging and/or use gadolinium-based contrast agents
- Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure
- Chronic immunosuppressive therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 6 centers
- Nagoya Central Hospital - Neurosurgery — Nagoya
- Nagoya University Hospital - Neurology — Nagoya
- Yokohama City University Medical Center - Neurology — Yokohama
- National Hospital Organization Osaka Toneyama Medical Center - Neurology — Toyonaka
- Juntendo University Hospital - Neurology — Bunkyo-ku
- National Hospital Organization Utano National Hospital - Neurology — Kyoto
Identifiers
NCT: NCT07566429 · 23015 · ASK-PD5-CS203