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



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:September 2009
End Date:December 2014
Contact:Sarah Walter, M.P.H.
Email:swalter@ucsd.edu
Phone:858-622-5863

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A Double-Blind, Placebo-Controlled (Sham Surgery), Randomized, Multicenter Study Evaluating CERE-110 Gene Delivery in Subjects With Mild to Moderate Alzheimer's Disease


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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- Significant neurological disease other than Alzheimer's disease

- Significant depression or other psychiatric disorder

- Unstable medical conditions
We found this trial at
11
sites
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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1 Gustave L Levy Pl # 504
New York, New York 10029
 (212) 241-6500
Mount Sinai School of Medicine Icahn School of Medicine at Mount Sinai is proud to...
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New York, NY
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10515 W Santa Fe Drive
Phoenix, Arizona 85351
623-875-6500
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Cleveland, OH
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San Diego, California 92093
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San Diego, CA
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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Washington,
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