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| ID | Type | Description | Link |
|---|---|---|---|
| NIH Grant 1R01AG030048-01A1 |
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| Name | Class |
|---|---|
| Alzheimer's Disease Cooperative Study (ADCS) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CERE-110 | Experimental | CERE-110: Adeno-Associated Virus Delivery of NGF |
|
| Placebo | Sham Comparator | Placebo Surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CERE-110: Adeno-Associated Virus injection Surgery | Drug | Injecting CERE-110 2.0 X 10^11 vg into brain during surgical procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological Test Battery | 24 Months | |
| Mini-Mental State Examination (MMSE) | 24 Months | |
| Neuropsychiatric Inventory (NPI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul S. Aisen, M.D. | Alzheimer's Disease Cooperative Study (ADCS) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| University of California, Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29582053 | Derived | 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. |
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| Placebo Surgery | Procedure | Placebo Surgery |
|
| 24 Months |
| Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) | 24 Months |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California, San Diego | San Diego | California | 92037 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Emory University | Atlanta | Georgia | 30325 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44120 | United States |
| Medical University of South Carolina | North Charleston | South Carolina | 29406 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D008569 | Memory Disorders |
| D060825 | Cognitive Dysfunction |
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D009421 | Nervous System Malformations |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
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