NIPH Clinical Trials Search

A study of AB-1005 gene therapy delivered to bilateral putamen in Japanese participants with Moderate stage Parkinsons Disease

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Parkinsons Disease
Date of first enrollment	17/07/2026
Target sample size	8
Countries of recruitment
Study type	Interventional
Intervention(s)	a single bilateral intraputaminal administration of AB-1005 (AAV2-GDNF Gene Therapy)

Outcome(s)

Primary Outcome	1. Incidence of adverse events up to Month 18 after study intervention 2. Change from Baseline to Month 18 in normalized Good ON time measured with Parkinson's disease Motor Diary
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 45age old
Age maximum	<= 75age old
Gender	Both
Include criteria	1. Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent 2. 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
Exclude criteria	1. Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis 2. Presence or history of significant vascular and/or cardiovascular disease 3. Presence of clinically significant cognitive impairment 4. Presence or history of psychosis or impulse control disorder 5. History of malignancy other than treated cutaneous squamous or basal cell carcinomas 6. Presence of clinically relevant conditions that could compromise surgical suitability and/or subject safety 7. Contraindication to magnetic resonance imaging and/or use gadolinium-based contrast agents 8. Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure 9. Chronic immunosuppressive therapy