Ignite Creation Date:
2024-05-05 @ 9:24 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00876863
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2009-04-03
Brief Title:
Randomized Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimers Disease
Sponsor:
Sangamo Therapeutics
Organization:
Sangamo Therapeutics
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Sham Surgery Randomized Multicenter Study Evaluating CERE-110 Gene Delivery in Subjects With Mild to Moderate Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2017-01
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:
The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment of Alzheimers disease CERE-110 is an experimental drug that is designed to help nerve cells in the brain function better CERE-110 uses a virus to transfer a gene that makes Nerve Growth Factor NGF a protein that may make nerve cells in the brain healthier and protect them from dying The virus used in CERE-110 does not cause disease in people CERE-110 has been carefully studied in laboratory animals and is in the early stages of being tested in people
Fifty patients with mild to moderate Alzheimers disease will participate in this study Half of the study subjects will have CERE-110 injected into the brain during a surgical procedure while the other half will undergo a placebo surgery where no medication will be injected All study participants will be followed for at least two years after surgery
Fifty patients with mild to moderate Alzheimers disease will participate in this study Half of the study subjects will have CERE-110 injected into the brain during a surgical procedure while the other half will undergo a placebo surgery where no medication will be injected All study participants will be followed for at least two years after surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH Grant 1R01AG030048-01A1 | None | None | None |