drugset / Trial / NCT00087789
CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease
Non-randomizedSingle-groupOpen-labelTreatment
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
- Start
- 2004-06
- Primary completion
- 2010-05
- Completion
- 2010-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CERE-110 | Gene therapy (AAV / viral vector) | 1 vg | — |
| Subject | CERE-110 | Gene therapy (AAV / viral vector) | 2 vg | — |