Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease
NCT ID: NCT00876863
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2008-11-30
2015-08-13
Brief Summary
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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 Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CERE-110
CERE-110: Adeno-Associated Virus Delivery of NGF
CERE-110: Adeno-Associated Virus injection Surgery
Injecting CERE-110 2.0 X 10\^11 vg into brain during surgical procedure.
Placebo
Placebo Surgery
Placebo Surgery
Placebo Surgery
Interventions
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CERE-110: Adeno-Associated Virus injection Surgery
Injecting CERE-110 2.0 X 10\^11 vg into brain during surgical procedure.
Placebo Surgery
Placebo Surgery
Eligibility Criteria
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Inclusion Criteria
* 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 depression or other psychiatric disorder
* Unstable medical conditions
55 Years
80 Years
ALL
No
Sponsors
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Alzheimer's Disease Cooperative Study (ADCS)
OTHER
Sangamo Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Paul S. Aisen, M.D.
Role: STUDY_DIRECTOR
Alzheimer's Disease Cooperative Study (ADCS)
Locations
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University of Alabama
Birmingham, Alabama, United States
University of California, Los Angeles
Los Angeles, California, United States
University of California, San Diego
San Diego, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Mount Sinai School of Medicine
New York, New York, United States
Duke University
Durham, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
Medical University of South Carolina
North Charleston, South Carolina, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Rafii MS, Tuszynski MH, Thomas RG, Barba D, Brewer JB, Rissman RA, Siffert J, Aisen PS; AAV2-NGF Study Team. Adeno-Associated Viral Vector (Serotype 2)-Nerve Growth Factor for Patients With Alzheimer Disease: A Randomized Clinical Trial. JAMA Neurol. 2018 Jul 1;75(7):834-841. doi: 10.1001/jamaneurol.2018.0233.
Other Identifiers
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NIH Grant 1R01AG030048-01A1
Identifier Type: -
Identifier Source: secondary_id
CERE-110-03
Identifier Type: -
Identifier Source: org_study_id