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| Sponsor: | Ceregene |
|---|---|
| Collaborator: |
Alzheimer's Disease Cooperative Study (ADCS) |
| Information provided by: | Ceregene |
| ClinicalTrials.gov Identifier: | NCT00876863 |
Purpose
The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment of Alzheimer's 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 Alzheimer's 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Genetic: CERE-110: Adeno-Associated Virus Delivery of NGF Procedure: Placebo Surgery |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Double-Blind, Placebo-Controlled (Sham Surgery), Randomized, Multicenter Study Evaluating CERE-110 Gene Delivery in Subjects With Mild to Moderate Alzheimer's Disease |
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
CERE-110: Experimental
CERE-110: Adeno-Associated Virus Delivery of NGF
|
Genetic: CERE-110: Adeno-Associated Virus Delivery of NGF
CERE-110 2.0 X 10^11 vg
|
|
Placebo: Sham Comparator
Placebo Surgery
|
Procedure: Placebo Surgery
Placebo Surgery
|
Eligibility| Ages Eligible for Study: | 55 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sarah Walter, M.S. | 858-622-5863 | swalter@ucsd.edu |
| Contact: Lisa Ann Melia, M.A. | 858-458-8848 | lmelia@ceregene.com |
| United States, Alabama | |
| University of Alabama | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Denise Ledlow 205-934-6223 pdledlow@uab.edu | |
| Principal Investigator: Ray L. Watts, M.D. | |
| United States, Arizona | |
| Sun Health Research Institute | Not yet recruiting |
| Sun City, Arizona, United States, 85351 | |
| Principal Investigator: Marwan Sabbagh, M.D. | |
| United States, California | |
| University of California, Los Angeles | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Jenny Bardens 310-794-6191 jbardens@mednet.ucla.edu | |
| Principal Investigator: Joshua D. Grill, Ph.D. | |
| University of California, San Diego | Recruiting |
| San Diego, California, United States, 92037 | |
| Contact: Mary M. Pay 858-622-5804 ext 1804 mpay@ucsd.edu | |
| Principal Investigator: Michael Rafii, M.D., Ph.D. | |
| United States, District of Columbia | |
| Georgetown University | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Kelly Behan 202-687-0413 keb53@georgetown.edu | |
| Principal Investigator: R. Scott Turner, M.D., Ph.D. | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30325 | |
| Contact: Stephanie Vyverberg Stephanie.Vyverberg@emoryhealthcare.org | |
| Principal Investigator: James J Lah, M.D. | |
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Judy Creighton 212-659-8885 Judy.Creighton@mssm.edu | |
| Principal Investigator: Judith A. Neugroschl, M.D. | |
| United States, North Carolina | |
| Duke University | Not yet recruiting |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: James R. Burke, M.D., Ph.D. | |
| United States, Ohio | |
| Case Western Reserve University | Recruiting |
| Cleveland, Ohio, United States, 44120 | |
| Principal Investigator: Alan J. Lerner, M.D. | |
| United States, South Carolina | |
| Medical University of South Carolina | Not yet recruiting |
| North Charleston, South Carolina, United States, 29406 | |
| Principal Investigator: Jacobo E. Mintzer, M.D. | |
| United States, Utah | |
| University of Utah | Not yet recruiting |
| Salt Lake City, Utah, United States, 84108 | |
| Principal Investigator: Edward Zamrini, M.D. | |
| Study Director: | Paul S. Aisen, M.D. | Alzheimer's Disease Cooperative Study (ADCS) |
More Information
| Responsible Party: | Alzheimer's Disease Cooperative Study ( Paul S. Aisen, M.D. ) |
| Study ID Numbers: | CERE-110-03, NIH Grant 1R01AG030048-01A1 |
| Study First Received: | April 3, 2009 |
| Last Updated: | February 3, 2010 |
| ClinicalTrials.gov Identifier: | NCT00876863 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Alzheimer's disease Dementia Memory loss Cognitive impairment |
|
Delirium, Dementia, Amnestic, Cognitive Disorders Alzheimer Disease Mental Disorders Nervous System Diseases Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |
