Not Yet Recruiting

Parkinson Disease

Bayer Identifier:

23015

ClinicalTrials.gov Identifier:

NCT07566429

EudraCT Number:

Not Available

EU CT Number:

Not Available

A study of AB-1005 gene therapy in Japanese adults with moderate Parkinson's Disease

Trial purpose

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).

Key Participants Requirements

Sex

All

Age

45 - 75 Years

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

Trial summary

Enrollment Goal

Trial Dates

July 2026 - June 2032

Phase

Phase II

Could I Receive a placebo

Products

Ametefgene Parvec, BAY 3657334

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Not Yet Recruiting	Nagoya Central Hospital - Neurosurgery	Nagoya, 453-0801, Japan
Not Yet Recruiting	National Hospital Organization Osaka Toneyama Medical Center - Neurology	Osaka, 560-8552, Japan
Not Yet Recruiting	Juntendo University Hospital - Neurology	Bunkyo-ku, 113-8431, Japan
Not Yet Recruiting	Nagoya University Hospital - Neurology	Nagoya, 466-8560, Japan
Not Yet Recruiting	Yokohama City University Medical Center - Neurology	Yokohama, 232-0024, Japan
Not Yet Recruiting	National Hospital Organization Utano National Hospital - Neurology	Kyoto, 616-8255, Japan

Primary Outcome

Incidence of adverse events up to Month 18 after study intervention
Number and proportion of participants with at least one adverse event
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

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

N/A

Blinding

Open Label

Assignment

Single Group

Trial Arms

Additional Information

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