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| ID | Type | Description | Link |
|---|---|---|---|
| GN00762 | Other Identifier | Hoffmann-La Roche |
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This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the effects of MABT5102A on brain amyloid burden (as assessed by amyloid PET imaging) and other biomarkers in patients with mild to moderate Alzheimer's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Subcutaneous cohort exp | Experimental |
| |
| Part 2: Intravenous cohort exp | Experimental |
| |
| Part 1: Subcutaneous cohort | Placebo Comparator | Repeating subcutaneous injection |
|
| Part 2: Intravenous cohort | Placebo Comparator | Repeating intravenous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MABT5102A | Drug | Repeating subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in brain amyloid load as assessed by amyloid PET imaging | Baseline to Week 69 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cerebrospinal fluid (CSF) biomarkers relevant to Alzheimer's disease | Baseline to Week 69 | |
| Change in brain metabolism as assessed by 18F-fluorodeoxyglucose positron emission tomography (FDG PET) imaging | Baseline to Week 69 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Paul, M.D., Ph.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Alzheimer's Institute | Phoenix | Arizona | 85020 | United States | ||
| Banner Sun Health Research Insitute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36946448 | Derived | Polhamus DG, Dolton MJ, Rogers JA, Honigberg L, Jin JY, Quartino A. Longitudinal Exposure-Response Modeling of Multiple Indicators of Alzheimer's Disease Progression. J Prev Alzheimers Dis. 2023;10(2):212-222. doi: 10.14283/jpad.2023.13. | |
| 31969177 | Derived | Yoshida K, Moein A, Bittner T, Ostrowitzki S, Lin H, Honigberg L, Jin JY, Quartino A. Pharmacokinetics and pharmacodynamic effect of crenezumab on plasma and cerebrospinal fluid beta-amyloid in patients with mild-to-moderate Alzheimer's disease. Alzheimers Res Ther. 2020 Jan 22;12(1):16. doi: 10.1186/s13195-020-0580-2. |
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| MABT5102A |
| Drug |
Repeating intravenous infusion |
|
| placebo | Drug | Repeating subcutaneous injection |
|
| placebo | Drug | Repeating intravenous infusion |
|
| Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS Cog) score | Baseline to Week 73 |
| Sun City |
| Arizona |
| 85351 |
| United States |
| NNS Clinical Research LLC | Tucson | Arizona | 85704 | United States |
| Margolin Brain Institute | Fresno | California | 93720 | United States |
| University of California Los Angeles (UCLA) | Los Angeles | California | 90095 | United States |
| Pacific Neuroscience Med Grp | Oxnard | California | 93030 | United States |
| Stanford Univ Medical Center | Palo Alto | California | 94304 | United States |
| Redwood Regional Medical Group | Santa Rosa | California | 95403 | United States |
| Internal Med Assoc of Lee Cty | Fort Myers | Florida | 33912 | United States |
| Neuropsychiatric Research; Center of Southwest Florida | Fort Myers | Florida | 33912 | United States |
| MD Clinical | Hallandale | Florida | 33009 | United States |
| Compass Research | Orlando | Florida | 32806 | United States |
| Dekalb Neurology Associates | Decatur | Georgia | 30033 | United States |
| Alexian Brothers Neurosci Inst | Elk Grove Village | Illinois | 60007 | United States |
| Hattiesburg Clinic | Hattiesburg | Mississippi | 39401 | United States |
| Cleveland Clinic Lou Ruvo; Center for Brain Research | Las Vegas | Nevada | 89106 | United States |
| Memory Enhancement Center of America, Inc. | Eatontown | New Jersey | 07724 | United States |
| Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch. | Manhasset | New York | 11030 | United States |
| Neurology & Neuroscience Ctr of Ohio | Toledo | Ohio | 43623 | United States |
| The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | 19046 | United States |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | 02914 | United States |
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
| Hopital Central-CHU de Nancy; Pharmacie | Nancy | 54035 | France |
| Hôpital Casselardit; Cons memoire | Toulouse | 31059 | France |
| Clinique Psychiatrique Univ | Tours | 37044 | France |
| Fundació ACE | BArcelon | Barcelona | 08034 | Spain |
| Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Mutua De Terrasa | Barcelona | 08221 | Spain |
| 30231896 | Derived | Salloway S, Honigberg LA, Cho W, Ward M, Friesenhahn M, Brunstein F, Quartino A, Clayton D, Mortensen D, Bittner T, Ho C, Rabe C, Schauer SP, Wildsmith KR, Fuji RN, Suliman S, Reiman EM, Chen K, Paul R. Amyloid positron emission tomography and cerebrospinal fluid results from a crenezumab anti-amyloid-beta antibody double-blind, placebo-controlled, randomized phase II study in mild-to-moderate Alzheimer's disease (BLAZE). Alzheimers Res Ther. 2018 Sep 19;10(1):96. doi: 10.1186/s13195-018-0424-5. |
| 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 |
|---|---|
| C573372 | crenezumab |
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