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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
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Genetic: CERE-110: Adeno-Associated Virus Delivery of NGF
Procedure: Placebo Surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ceregene:

Primary Outcome Measures:
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: September 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CERE-110
CERE-110: Adeno-Associated Virus Delivery of NGF
Genetic: CERE-110: Adeno-Associated Virus Delivery of NGF
CERE-110 2.0 X 10^11 vg
Sham Comparator: Placebo
Placebo Surgery
Procedure: Placebo Surgery
Placebo Surgery

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876863

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
University of California, San Diego
San Diego, California, United States, 92037
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30325
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44120
United States, South Carolina
Medical University of South Carolina
North Charleston, South Carolina, United States, 29406
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Ceregene
Alzheimer's Disease Cooperative Study (ADCS)
Investigators
Study Director: Paul S. Aisen, M.D. Alzheimer's Disease Cooperative Study (ADCS)
  More Information

No publications provided

Responsible Party: Ceregene
ClinicalTrials.gov Identifier: NCT00876863     History of Changes
Other Study ID Numbers: CERE-110-03, NIH Grant 1R01AG030048-01A1
Study First Received: April 3, 2009
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ceregene:
Alzheimer's disease
Dementia
Memory loss
Cognitive impairment
Nerve growth factor
NGF
Neurotrophic factors
Gene therapy

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 19, 2014