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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: Sangamo Therapeutics

Current Primary Outcome: Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 24 Months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Sangamo Therapeutics

Dates:
Date Received: April 3, 2009
Date Started: September 2009
Date Completion: March 2020
Last Updated: January 6, 2017
Last Verified: January 2017