Alzheimer's Disease Education and Referral Center

CERE-110 in Subjects with Mild to Moderate Alzheimer's Disease

CERE-110 in Subjects with Mild to Moderate Alzheimer's Disease

Overall Status: 
No longer recruiting
Brief Description: 

The purpose of this study is to evaluate the potential benefits of CERE-110, an experimental drug, in the treatment of Alzheimer's disease (AD).

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
55 Years
80 Years
Both
No
Inclusion Criteria: 

  • Males and females 55-80 years old
  • MMSE score between 17 and 26
  • Modified Hachinski score less than or equal to 4
  • Stable doses of approved AD meds for 3 months prior to screening allowed; must remain stable for at least the first year after administration of CERE-110
  • Stable dose of Vitamin E not to exceed 1000 mg twice a day for 3 months prior to screening allowed; must remain stable for at least the first year after administration of CERE-110
  • Availability of study partner (10 hrs./week contact; participate in all visits)
  • Able to understand and comply with visit schedule and study procedures
  • Physically and mentally capable of performing required assessments
  • Medically able to undergo neurosurgery
  • Brain MRI at baseline without evidence of infection, infarction, or other focal (e.g., subdural hematomas, tumor, etc.) or generalized lesions (e.g., normal pressure or obstructive hydrocephalus, widespread infarcts, etc.)

Exclusion Criteria: 

  • Significant neurological disease other than AD
  • Depression, major psychiatric disorder, psychotic features, behavioral problems
  • Alcohol or substance abuse within past 2 years
  • Systemic cancer within past 3 years
  • Aphasia that could interfere with neuropsychometric testing
  • Any significant systemic illness or unstable medical condition

Detailed Description: 

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 participants 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 2 years after surgery.

Locations: 
Map MarkerCityStateZip CodePrimary Contact

Geolocation is 33.5075555, -86.8093239

Birmingham
Alabama
35294
Name:
Phone:

Geolocation is 34.070264, -118.4440562

Los Angeles
California
90095
Name:
Phone:

Geolocation is 32.84722, -117.27333

San Diego
California
92037
Name:
Phone:

Geolocation is 38.9156487, -77.0737149

Washington
District of Columbia
20007
Name:
Phone:

Geolocation is 33.8373942, -84.4201836

Atlanta
Georgia
30325
Name:
Phone:

Geolocation is 40.7916407, -73.9447994

New York
New York
10029
Name:
Phone:

Geolocation is 36.0038131, -78.9387241

Durham
North Carolina
27710
Name:
Phone:

Geolocation is 41.4769163, -81.5760945

Cleveland
Ohio
44120
Name:
Phone:

Geolocation is 32.9221152, -80.0367259

North Charleston
South Carolina
29406
Name:
Phone:

Geolocation is 40.7834328, -111.7376178

Salt Lake City
Utah
84108
Name:
Phone:
Lead Sponsor: 
Agency
Ceregene
Collaborator Sponsor: 
Agency
Alzheimer's Disease Cooperative Study (ADCS)
Facility Investigators: 
NameRoleAffiliation
Paul S. Aisen, M.D.
Study Director
Alzheimer's Disease Cooperative Study (ADCS)
Study Contact: 
NamePhoneEmail
Sarah Walter, M.P.H.
858-622-5863
Locations
 
 
ClinicalTrials.gov ID 
Official Title: 
Randomized, Controlled Study Evaluating CERE-110 in Subjects with Mild to Moderate Alzheimer's Disease
Study Start Date: 
September 2009
Study End Date: 
December 2014
Disease Stage: 
Early
Middle
Enrollment: 
50