Is a
Clinical Study attributes
NCT Number
Health Conditions in Trial
Trial Recruitment Size
100
Trial Sponsor
Trial Collaborator
Clinical Trial Start Date
2004
0Primary Completion Date
2010
0Study Completion Date
2010
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Interventional Trial Phase
Phase 10
Participating Facility
Official Name
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 Disease0
Last Updated
November 10, 2022
0Allocation Type
Non-Randomized0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study 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.
Timeline
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