Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00876863
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : November 20, 2019
Sponsor:
Collaborator:
Alzheimer's Disease Cooperative Study (ADCS)
Information provided by (Responsible Party):
Sangamo Therapeutics

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.


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: CERE-110: Adeno-Associated Virus Delivery of NGF Procedure: Placebo Surgery Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : November 2008
Actual Primary Completion Date : August 13, 2015
Actual Study Completion Date : August 13, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CERE-110
CERE-110: Adeno-Associated Virus Delivery of NGF
Drug: 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




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

Secondary Outcome Measures :
  1. Neuropsychological Test Battery [ Time Frame: 24 Months ]
  2. Mini-Mental State Examination (MMSE) [ Time Frame: 24 Months ]
  3. Neuropsychiatric Inventory (NPI) [ Time Frame: 24 Months ]
  4. Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 24 Months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876863


Locations
Layout table for location information
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
Sangamo Therapeutics
Alzheimer's Disease Cooperative Study (ADCS)
Investigators
Layout table for investigator information
Study Director: Paul S. Aisen, M.D. Alzheimer's Disease Cooperative Study (ADCS)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sangamo Therapeutics
ClinicalTrials.gov Identifier: NCT00876863     History of Changes
Other Study ID Numbers: CERE-110-03
NIH Grant 1R01AG030048-01A1
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: January 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sangamo Therapeutics:
Alzheimer's disease
Dementia
Memory loss
Cognitive impairment
Nerve growth factor
NGF
Neurotrophic factors
Gene therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders