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

NCTID	NCT00876863 (View at clinicaltrials.gov)
Description	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. (Show More)
Development Status	Inactive
Indication	Alzheimer's Disease
Disease Ontology Term	DOID:10652
Compound Name	CERE-110
Compound Description	AAV2-NGF
Sponsor	Sangamo Therapeutics
Funder Type	Industry
Recruitment Status	Completed
Enrollment Count	49 (ACTUAL)
Results Posted	Not Available

Target Gene/Variant	NGF
Therapy Type	Gene transfer
Therapy Route	In-vivo
Mechanism of Action	Overexpression of protective allele/gene
Route of Administration	Intraparenchymal
Drug Product Type	Viral vector
Target Tissue/Cell	Nucleus basalis of Meynert
Delivery System	Viral transduction
Vector Type	AAV2
Editor Type	none
Dose 1	1.2E10 vg (Phase I)
Dose 2	5.8E10 vg (Phase I)
Dose 3	1.2E11 vg (Phase I)
Dose 4	2.0E11 vg (Phase II)

Eligible Age	55 Years - 80 Years
Standard Ages	Adult, Older adult
Sexes Eligible for Study	ALL
Eligibility Criteria	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 View Inclusion and Exclusion Criteria at ClinicalTrials.gov

No.of Trial Sites	10
Locations	United States

Has US IND	True
FDA Designations
Recent Updates	Program was terminated in April 2015