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

NCT00876863 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2020-12-21

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Alzheimer's Disease Cooperative Study (ADCS)

    collaborator OTHER

  • Sangamo Therapeutics

    lead INDUSTRY

Principal Investigators

  • Paul S. Aisen, M.D. · Alzheimer's Disease Cooperative Study (ADCS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2015-08-13
Completion
2015-08-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00876863 on ClinicalTrials.gov