NCT00087789

CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease

A Phase I, Dose-Escalating Study to Assess the Safety and Tolerability of CERE-110 [Adeno-Associated Virus (AAV)-Based Vector-Mediated Delivery of Beta-Nerve Growth Factor (NGF)] in Subjects With Mild to Moderate Alzheimer's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sangamo Therapeutics · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I clinical study to assess the safety, tolerability and biologic activity of in vivo AAV-mediated delivery of CERE-110. Up to 12 subjects will receive open label CERE-110 in dose-escalating fashion. All subjects will receive bilateral, stereotactic injections of CERE-110 for a total of four (Dose A and B) and six (Dose C) injections to target the basal forebrain region of the brain containing the nucleus basalis of Meynert (NBM). All study participants will be observed for a 24-month period and then followed annually.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
GENETIC	CERE-110: Adeno-Associated Virus Delivery of NGF	CERE-110 2.0 x 10\^10 vg, CERE-110 1.0 x 10\^11 vg, CERE-110 2.0 x 10\^11 vg

Timeline

• Start date: 2004-06-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2004-07-16
• Last updated: 2022-11-10

Locations

2 sites across 1 country: United States