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A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease (J-REGENERATE-PD)

Not Yet RecruitingPhase 2

Sponsor: Bayer

Conditions: Parkinson Disease

Interventions: AB-1005

Countries: Japan

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).

Eligibility overview

Sex: ALL

Age: 45 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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:

  1. Presence of bradykinesia PLUS any of the following: rigidity, rest tremor, postural instability
  2. Presence of motor fluctuations as measured by the PD Motor Diary
  3. Stable anti-parkinsonian medication regimen for 4 weeks or more, prior to screening
  4. 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

Locations (6)

Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Yokohama, Kanagawa, Japan
Toyonaka, Osaka, Japan
Bunkyo-ku, Tokyo, Japan
Kyoto, Japan