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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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A Phase II clinical research study to evaluate the efficacy and safety of two different dose levels of an injectable investigational treatment (ACC-001) in subjects with Mild-to-Moderate Alzheimer's disease. ACC-001 (vanutide cridificar) is a beta amyloid fragment attached to a carrier protein. It is intended to help induce an antibody response against beta amyloid and is administered as an intramuscular injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 μg ACC-001 / QS-21 50 μg IM dose 1 | Experimental | 3 μg ACC-001 / QS-21 50 μg IM |
|
| 10 μg ACC-001 / QS-21 50 μg IM dose 2 | Experimental | 10 μg ACC-001 / QS-21 50 μg IM |
|
| Placebo - Phosphate buffered saline (PBS) IM dose | No Intervention | Placebo - Phosphate buffered saline (PBS) IM |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACC-001 (vanutide cridificar) | Biological | Comparisons of 2 different doses of ACC-001 or placebo for 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of ACC-001 in combination with an adjuvant immunostimulatory agent (QS-21), administered intramuscularly compared to placebo on cerebral amyloid burden in subjects with mild to moderate Alzheimer's disease. | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of 2 dosage levels of ACC-001 plus QS-21 vs. placebo in subjects with mild to moderate AD. | As assessed by:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Janssen AI Investigational Site | Sun City | Arizona | 33613 | United States | ||
| Janssen AI Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29199321 | Derived | Ketter N, Liu E, Di J, Honig LS, Lu M, Novak G, Werth J, LePrince Leterme G, Shadman A, Brashear HR. A Randomized, Double-Blind, Phase 2 Study of the Effects of the Vaccine Vanutide Cridificar with QS-21 Adjuvant on Immunogenicity, Safety and Amyloid Imaging in Patients with Mild to Moderate Alzheimer's Disease. J Prev Alzheimers Dis. 2016;3(4):192-201. doi: 10.14283/jpad.2016.118. |
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|
| 24 Months |
| Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in disease biomarkers. | 24 Months |
| Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in measurements of immunogenicity. | 24 Months |
| Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in cognitive and functional scales. | 24 Months |
| Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in health outcome measures. | 24 Months |
| La Jolla |
| California |
| 92093 |
| United States |
| Janssen AI Investigational Site | Long Beach | California | 90806 | United States |
| Janssen AI Investigational Site | Los Angeles | California | 90095 | United States |
| Janssen AI Investigational Site | Oxnard | California | 93030 | United States |
| Janssen AI Investigational Site | San Diego | California | 92103 | United States |
| Janssen AI Investigational Site | San Francisco | California | 94143 | United States |
| Janssen AI Investigational Site | Washington D.C. | District of Columbia | 20057 | United States |
| Janssen AI Investigational Site | Miami | Florida | 33137 | United States |
| Janssen AI Investigational Site | Miami | Florida | 33410 | United States |
| Janssen AI Investigational Site | Ocala | Florida | 34471 | United States |
| Janssen AI Investigational Site | Orlando | Florida | 32806 | United States |
| Janssen AI Investigational Site | Sunrise | Florida | 33351 | United States |
| Janssen AI Investigational Site | Tampa | Florida | 33609 | United States |
| Janssen AI Investigational Site | Tampa | Florida | 33617 | United States |
| Janssen AI Investigational Site | West Palm Beach | Florida | 33407 | United States |
| Janssen AI Investigational Site | Scarborough | Maine | 04074 | United States |
| Janssen AI Investigational Site | Boston | Massachusetts | 02115 | United States |
| Janssen AI Investigational Site | Kansas City | Missouri | 64111 | United States |
| Janssen AI Investigational Site | Las Vegas | Nevada | 89106 | United States |
| Janssen AI Investigational Site | Princeton | New Jersey | 08540 | United States |
| Janssen AI Investigational Site | Albany | New York | 12205 | United States |
| Janssen AI Investigational Site | New York | New York | 10032 | United States |
| Janssen AI Investigational Site | Centerville | Ohio | 45459 | United States |
| Janssen AI Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000603458 | vanutide cridificar |
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