Parkinsons Disease
Conditions
Interventions
a single bilateral intraputaminal administration of AB-1005 (AAV2-GDNF Gene Therapy)
Sponsors
Myoishi Masafumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public Contactcontact Dedicated
Bayer Yakuhin, Ltd.
Outcome results
None listed