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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876863
• Other study ID #: CERE-110-03
• Secondary ID: NIH Grant 1R01AG
• Status: Completed
• Phase: Phase 2
• Start date: November 2008
• Est. completion date: August 13, 2015

Study information

• Verified date: January 2017
• Source: Sangamo Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 13, 2015
• Est. primary completion date: August 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• CERE-110: Adeno-Associated Virus injection Surgery
Injecting CERE-110 2.0 X 10^11 vg into brain during surgical procedure.

Procedure:
• Placebo Surgery
Placebo Surgery

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Sangamo Therapeutics	Alzheimer's Disease Cooperative Study (ADCS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)		24 Months
Secondary	Neuropsychological Test Battery		24 Months
Secondary	Mini-Mental State Examination (MMSE)		24 Months
Secondary	Neuropsychiatric Inventory (NPI)		24 Months
Secondary	Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)		24 Months