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Clinical Trial Report

Gene Therapy Trial Report

Summary

Gene Therapy for APOE4 Homozygote of Alzheimer's Disease


NCTID NCT03634007 (View at clinicaltrials.gov)
Description
Indication Alzheimer's Disease
Compound Name LX1001 (AAVrh.10hAPOE2-HA)
Sponsor Lexeo Therapeutics
Funder Type Industry
Status
Active not recruiting
Enrollment Count 15

Therapy Information


Target Gene/Variant APOE2
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Overexpression of protective allele/gene
Route of Administration Intrathecal
Drug Product Type Viral vector
Target Tissue/Cell
Delivery System Viral transduction
Vector Type AAVrh10
Editor Type
Dose 1 1.4 x 10^10 gc/mL CSF
Dose 2 4.4 x 10^10 gc/mL CSF
Dose 3 1.4 x 10^11 gc/mL CSF
Dose 4 1.4 x 10^14 gc (fixed dose)
Dose 5

Study Record Dates


Current Stage Phase1, Phase2
Submit Date 2018-08-03
Completion Date 2024-11
Last Update 2023-11-15

Participation Criteria


Eligible Age >=50 Years
Standard Ages Adult, Older adult
Eligible Sex ALL

Locations


No.of Trial Sites 4
Locations United States

Regulatory Information


Has US IND True
Recent Updates Interim Phase 1/2 data readout (all cohorts) 2H 2024

Resources/Links