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

Sangamo Therapeutics

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Procedure: Placebo Surgery; Drug: CERE-110: Adeno-Associated Virus injection Surgery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00876863

NIH Grant 1R01AG030048-01A1

CERE-110-03

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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49 participants in 2 patient groups

CERE-110

Experimental group

Description:

CERE-110: Adeno-Associated Virus Delivery of NGF

Treatment:

Drug: CERE-110: Adeno-Associated Virus injection Surgery

Placebo

Sham Comparator group

Description:

Placebo Surgery

Treatment:

Procedure: Placebo Surgery