CERE-110 in Subjects with Mild to Moderate Alzheimer's Disease
CERE-110 in Subjects with Mild to Moderate Alzheimer's Disease
Overall Status:
No longer recruiting
Brief Description:
The purpose of this study is to evaluate the potential benefits of CERE-110, an experimental drug, in the treatment of Alzheimer's disease (AD).
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
55 Years | 80 Years | Both | No |
Inclusion Criteria:
- Males and females 55-80 years old
- MMSE score between 17 and 26
- Modified Hachinski score less than or equal to 4
- Stable doses of approved AD meds for 3 months prior to screening allowed; must remain stable for at least the first year after administration of CERE-110
- Stable dose of Vitamin E not to exceed 1000 mg twice a day for 3 months prior to screening allowed; must remain stable for at least the first year after administration of CERE-110
- Availability of study partner (10 hrs./week contact; participate in all visits)
- Able to understand and comply with visit schedule and study procedures
- Physically and mentally capable of performing required assessments
- Medically able to undergo neurosurgery
- Brain MRI at baseline without evidence of infection, infarction, or other focal (e.g., subdural hematomas, tumor, etc.) or generalized lesions (e.g., normal pressure or obstructive hydrocephalus, widespread infarcts, etc.)
Exclusion Criteria:
- Significant neurological disease other than AD
- Depression, major psychiatric disorder, psychotic features, behavioral problems
- Alcohol or substance abuse within past 2 years
- Systemic cancer within past 3 years
- Aphasia that could interfere with neuropsychometric testing
- Any significant systemic illness or unstable medical condition
Detailed Description:
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 Alzheimer's disease will participate in this study. Half of the study participants 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 2 years after surgery.
Locations:
| Map Marker | City | State | Zip Code | Primary Contact |
|---|---|---|---|---|
Geolocation is 33.5075555, -86.8093239 | Birmingham | Alabama | 35294 | Name: Phone: |
Geolocation is 34.070264, -118.4440562 | Los Angeles | California | 90095 | Name: Phone: |
Geolocation is 32.84722, -117.27333 | San Diego | California | 92037 | Name: Phone: |
Geolocation is 38.9156487, -77.0737149 | Washington | District of Columbia | 20007 | Name: Phone: |
Geolocation is 33.8373942, -84.4201836 | Atlanta | Georgia | 30325 | Name: Phone: |
Geolocation is 40.7916407, -73.9447994 | New York | New York | 10029 | Name: Phone: |
Geolocation is 36.0038131, -78.9387241 | Durham | North Carolina | 27710 | Name: Phone: |
Geolocation is 41.4769163, -81.5760945 | Cleveland | Ohio | 44120 | Name: Phone: |
Geolocation is 32.9221152, -80.0367259 | North Charleston | South Carolina | 29406 | Name: Phone: |
Geolocation is 40.7834328, -111.7376178 | Salt Lake City | Utah | 84108 | Name: Phone: |
Lead Sponsor:
| Agency |
|---|
Ceregene |
Collaborator Sponsor:
| Agency |
|---|
Alzheimer's Disease Cooperative Study (ADCS) |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Paul S. Aisen, M.D. | Study Director | Alzheimer's Disease Cooperative Study (ADCS) |
Study Contact:
| Name | Phone | |
|---|---|---|
Sarah Walter, M.P.H. | 858-622-5863 |
Locations
ClinicalTrials.gov ID
NCT00876863 (follow link to view full record on ct.gov in new window)
Official Title:
Randomized, Controlled Study Evaluating CERE-110 in Subjects with Mild to Moderate Alzheimer's Disease
Study Start Date:
September 2009
Study End Date:
December 2014
Disease Stage:
Early
Middle
Enrollment:
50
