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| Sponsor: | Ceregene |
|---|---|
| Collaborator: |
Alzheimer's Disease Cooperative Study (ADCS) |
| Information provided by (Responsible Party): | 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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CERE-110
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
|
|
Sham Comparator: Placebo
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.P.H. | 858-622-5863 | swalter@ucsd.edu |
| Contact: Tiffany Baumann | 858-458-8853 | tbaumann@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 | |
| Banner Sun Health Research Institute | Recruiting |
| Sun City, Arizona, United States, 85351 | |
| Contact: Karen Kohl 623-875-6512 karen.kohl@bannerhealth.com | |
| Principal Investigator: Marwan Sabbagh, M.D. | |
| United States, California | |
| University of California, Los Angeles | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Joanna Quach 310-794-6191 jquach@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: Rebecca McMurray 404-728-6427 rmcmurr@emory.edu | |
| Principal Investigator: James J Lah, M.D., Ph.D. | |
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Priyanka Ghosh 212-659-8885 priyanka.ghosh@mssm.edu | |
| Principal Investigator: Judith A. Neugroschl, M.D. | |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Debra Heydt 919-668-2843 debra.heydt@duke.edu | |
| Principal Investigator: James R. Burke, M.D., Ph.D. | |
| United States, Ohio | |
| Case Western Reserve University | Recruiting |
| Cleveland, Ohio, United States, 44120 | |
| Contact: Leon Hudson 216-464-6474 leon.hudson@case.edu | |
| Principal Investigator: Alan J. Lerner, M.D. | |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| North Charleston, South Carolina, United States, 29406 | |
| Contact: Beth Safrit 843-740-1592 ext 38 safritm@musc.edu | |
| Principal Investigator: Jacobo E. Mintzer, M.D. | |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84108 | |
| Contact: Cam Torres 801-587-8385 cam.torres@hsc.utah.edu | |
| Principal Investigator: Edward Zamrini, M.D. | |
| Study Director: | Paul S. Aisen, M.D. | Alzheimer's Disease Cooperative Study (ADCS) |
More Information
| Responsible Party: | Ceregene |
| ClinicalTrials.gov Identifier: | NCT00876863 History of Changes |
| Other Study ID Numbers: | CERE-110-03, NIH Grant 1R01AG030048-01A1 |
| Study First Received: | April 3, 2009 |
| Last Updated: | November 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Alzheimer's disease Dementia Memory loss Cognitive impairment |
Nerve growth factor NGF Neurotrophic factors Gene therapy |
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
