Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087789
Status:
COMPLETED
Last Update Posted:
2022-11-10
First Post:
2004-07-13
Brief Title:
CERE-110 in Subjects With Mild to Moderate Alzheimers Disease
Sponsor:
Sangamo Therapeutics
Organization:
Sangamo Therapeutics
Study Overview
Official Title:
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 Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None