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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Alzheimer's Disease Cooperative Study (ADCS)
Information provided by (Responsible Party):
Ceregene
ClinicalTrials.gov Identifier:
NCT00876863
First received: April 3, 2009
Last updated: December 10, 2012
Last verified: December 2012

April 3, 2009
December 10, 2012
September 2009
December 2014   (final data collection date for primary outcome measure)
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00876863 on ClinicalTrials.gov Archive Site
  • Neuropsychological Test Battery [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Mini-Mental State Examination (MMSE) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease
A Double-Blind, Placebo-Controlled (Sham Surgery), Randomized, Multicenter Study Evaluating CERE-110 Gene Delivery in Subjects With Mild to Moderate Alzheimer's Disease

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Genetic: CERE-110: Adeno-Associated Virus Delivery of NGF
    CERE-110 2.0 X 10^11 vg
  • Procedure: Placebo Surgery
    Placebo Surgery
  • Experimental: CERE-110
    CERE-110: Adeno-Associated Virus Delivery of NGF
    Intervention: Genetic: CERE-110: Adeno-Associated Virus Delivery of NGF
  • Sham Comparator: Placebo
    Placebo Surgery
    Intervention: Procedure: Placebo Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
55 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00876863
CERE-110-03, NIH Grant 1R01AG030048-01A1
Yes
Ceregene
Ceregene
Alzheimer's Disease Cooperative Study (ADCS)
Study Director: Paul S. Aisen, M.D. Alzheimer's Disease Cooperative Study (ADCS)
Ceregene
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP