A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease (J-REGENERATE-PD)
ConditionParkinson Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age45-75
SponsorBayer
About this trial
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 criteria
Qualifiers
Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- AB-1005
Treatment groups
8 Participants
are divided into 1 treatment groupSponsors and collaborators
Bayer
Lead sponsor
AskBio Inc
Collaborator
Source ClinicalTrials.gov