Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT00876863

Run by

Sangamo Therapeutics

People needed

49

Starts

2008-11-01

Expected to finish

2015-08-13

Last updated by the study team

2020-12-21

Who can join

Age: 55 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• University of California, Los Angeles — Los Angeles, California, United States
• University of California, San Diego — San Diego, California, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Emory University — Atlanta, Georgia, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Medical University of South Carolina — North Charleston, South Carolina, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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