Summary

for people ages 55-80 (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

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.

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

Keywords

Alzheimer's Disease Dementia Memory loss Cognitive impairment Nerve growth factor NGF Neurotrophic factors Gene therapy Alzheimer Disease CERE-110: Adeno-Associated Virus Delivery of NGF CERE-110

Eligibility

You can join if…

Open to people ages 55-80

  • Diagnosis of mild to moderate Alzheimer's disease
  • Approved medications for Alzheimer's disease may be taken 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

You CAN'T join if...

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

Locations

  • University of California, San Diego
    San Diego California 92037 United States
  • University of California, Los Angeles
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sangamo Therapeutics
ID
NCT00876863
Phase
Phase 2
Study Type
Interventional
Last Updated