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Sponsored by: |
Ceregene |
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Information provided by: | Ceregene |
ClinicalTrials.gov Identifier: | NCT00087789 |
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.
Condition | Intervention | Phase |
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Alzheimer's Disease |
Genetic: CERE-110: adeno-associated virus delivery of NGF |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I, Dose-Escalating Study to Assess the Safety and Tolerability of CERE-110 [Adeno-Associated Virus (AAV)-Based Vector-Mediated Delivery of Beta-Nerve Growth Factor (NGF)] in Subjects With Mild to Moderate Alzheimer's Disease |
Enrollment: | 10 |
Study Start Date: | June 2004 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 50 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
a competent and willing subject, and a surrogate identified by the participant, or a legally authorized power of attorney for Health Care, or a family member
Exclusion Criteria:
United States, California | |
University of California San Diego | |
San Diego, California, United States, 92037 | |
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 |
Responsible Party: | Ceregene, Inc. ( Joao Siffert, MD; VP, Chief Medical Officer ) |
Study ID Numbers: | CERE-110-01 |
Study First Received: | July 13, 2004 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00087789 |
Health Authority: | United States: Food and Drug Administration |
Alzheimer's Disease Gene Transfer |
Virus Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |