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Nerve Growth Factor Gene Delivery for Alzheimer’s Disease

Purpose

This study will examine the safety and efficacy of gene transfer delivered directly to the brain via neurosurgery. Patients will undergo a one-time surgical injection of an experimental therapeutic agent that may prevent neuronal death and stimulate neuronal function in the brain. Subjects will then be assessed approximately once every other month for two years as part of the study. You have a 50% chance of receiving the experimental agent. For more information, please contact Celine Ossinalde at (310) 794-6191 or This email address is being protected from spambots. You need JavaScript enabled to view it. .

Sponsor: Ceregene
Collaborator: Alzheimer's Disease Cooperative Study (ADCS)
ClinicalTrials.gov Identifier: NCT00876863

Condition: Intervention Phase
Alzheimer's Disease CERE-110 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 (5 at UCLA)
Eligibility
Ages Eligible for Study: 50 Years to 80 Years
Genders Eligible for Study: Both
Criteria

Inclusion Criteria:

Diagnosis of Alzheimer's disease
Approved treatments for Alzheimer's disease are permitted if the dose has been stable for 3 months
A study partner who can attend all study visits
Good general health
Medically able to undergo neurosurgery

Exclusion Criteria:

Significant neurological disease other than Alzheimer's disease
Significant depression or other psychiatric disorder
Unstable medical conditions

Contact: Celine Ossinalde at (310) 794-6191 This email address is being protected from spambots. You need JavaScript enabled to view it. for more information.