A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)

NCTID	NCT06285643 (View at clinicaltrials.gov)
Description	The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease. (Show More)
Indication	Parkinson's Disease
Compound Name	AB-1005 (AAV2-GDNF)
Sponsor	Asklepios Biopharmaceutical, Inc.
Funder Type	Industry
Status	Recruiting
Enrollment Count	87

Target Gene/Variant	GDNF
Therapy Type	Gene transfer
Therapy Route	In-vivo
Mechanism of Action	Overexpression of protective allele/gene
Route of Administration	CED
Drug Product Type	Viral vector
Target Tissue/Cell
Delivery System	Viral transduction
Vector Type	AAV2
Editor Type
Dose 1	Up to 1.8mL (3.3 x 10^12 vg/ml/gadoteridol 2mM co-infusion)
Dose 2
Dose 3
Dose 4
Dose 5

No.of Trial Sites	18
Locations	United States

Has US IND	True
Recent Updates	Received FDA Fast Track designation