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

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Procedure: Placebo Surgery

• Registration Number: NCT00876863
• Lead Sponsor: Sangamo Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-03
• Study First Posted: 2009-04-07
• Primary Completion: 2015-08-13
• Study Completion: 2015-08-13
• Status Verified: 2017-01
• Disposition First Submitted: 2020-04-16
• Disposition First Submitted QC: 2020-04-16
• Disposition First Posted: 2020-04-22
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Surgery	Placebo Surgery

Primary Outcome Measures

Name	Time	Method
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)	24 Months

Secondary Outcome Measures

Name	Time	Method
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)	24 Months
Neuropsychological Test Battery	24 Months
Mini-Mental State Examination (MMSE)	24 Months
Neuropsychiatric Inventory (NPI)	24 Months

Trial Locations

Locations (10)

Georgetown University; 🇺🇸 Washington, District of Columbia, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Medical University of South Carolina; 🇺🇸 North Charleston, South Carolina, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States