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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002477-98 | EudraCT Number | ||
| 2023-509678-52-00 | Other Identifier | EU Trial Number |
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The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of multiple-ascending intravenous (IV) doses of RO7126209 in participants with prodromal or mild to moderate Alzheimer's disease (AD), who are amyloid positive based on amyloid positron emission tomography (PET) scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (Dose Finding) Cohort 1: Dose Level 1 of RO7126209 | Experimental | Participants will receive multiple doses of RO7126209 at dose level 1 once every 4 weeks (Q4W) for 28 weeks followed by a 28-week safety follow-up period. |
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| Part 1 (Dose Finding) Cohort 1: Placebo | Placebo Comparator | Participants will receive matching placebo to dose level 1 Q4W for 28 weeks followed by a 28-week safety follow-up period. |
|
| Part 1 (Dose Finding) Cohort 2: Dose Level 2 of RO7126209 | Experimental | Participants will receive multiple doses of RO7126209 at dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
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| Part 1 (Dose Finding) Cohort 2: Placebo | Placebo Comparator | Participants will receive matching placebo to dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
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| Part 1 (Dose Finding) Cohort 3: Dose Level 3 of RO7126209 | Experimental | Participants will receive multiple doses of RO7126209 at dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7126209 | Drug | RO7126209 will be administered intravenously as specified in each treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1, 2, 3, and 4: Percentage of Participants With Adverse Events (AEs) | Part 1 and 2: Up to approximately 56 weeks; Part 3: Up to approximately 52 weeks; Part 4: Up to approximately 233 weeks | |
| Part 3: Change From Baseline in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan | Up to approximately 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1, 2, and 4: Change From Baseline in Brain Amyloid Load as Measured by Amyloid PET Scan | Part 1 and 2: Up to approximately 28 weeks; Part 4: Up to approximately 205 weeks | |
| Part 1, 2, 3, and 4: Plasma Concentration of RO7126209 | Part 1 and 2: Up to approximately 32 weeks; Part 3: Up to approximately 24 weeks; Part 4: Up to approximately 209 weeks |
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Key inclusion criteria for part 1, 2 and 3:
Inclusion criteria for Part 4:
- Completed the treatment period in Part 1, Part 2, or Part 3 of the study
Key exclusion criteria for part 1, 2 and 3:
Exclusion criteria for Part 4:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JEM Research LLC | Atlantis | Florida | 33462 | United States | ||
| K2 Medical Research-Winter Garden |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Part 1 (Dose Finding) Cohort 3: Placebo | Placebo Comparator | Participants will receive matching placebo to dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
|
| Part 1 (Dose Finding) Cohort 4: Dose Level 4 of RO7126209 | Experimental | Participants will receive multiple doses of RO7126209 at dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
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| Part 1 (Dose Finding) Cohort 4: Placebo | Placebo Comparator | Participants will receive matching placebo to dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
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| Part 1 (Dose Finding) Cohort 5: Dose Level 5 of RO7126209 | Experimental | Participants will receive a total of 2 doses of RO7126209 at dose level 5 Q4W, for 28 weeks followed by an 8-week safety follow-up period. |
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| Part 1 (Dose Finding) Cohort 5: Placebo | Placebo Comparator | Participants will receive a total of 2 doses of matching placebo to dose level 5 Q4W, for 28 weeks followed by an 8-week safety follow-up period. |
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| Part 2 (Expansion) Cohort 1: Dose Level 3 of RO7126209 | Experimental | Participants will receive multiple doses of RO7126209 at dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
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| Part 2 (Expansion) Cohort 1: Placebo | Placebo Comparator | Participants will receive matching placebo to dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
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| Part 2 (Expansion) Cohort 2: Dose Level 4 of RO7126209 | Experimental | Participants will receive multiple doses of RO7126209 at dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
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| Part 2 (Expansion) Cohort 2: Placebo | Placebo Comparator | Participants will receive matching placebo to dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
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| Part 2 (Expansion) Cohort 3: Dose Level 5 of RO7126209 | Experimental | Participants will receive a total of 2 doses of RO7126209 at dose level 5, Q4W, for 28 weeks followed by an 8-week safety follow-up period. |
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| Part 2 (Expansion) Cohort 3: Placebo | Placebo Comparator | Participants will receive a total of 2 doses of matching placebo to dose level 5, Q4W, for 28 weeks followed by an 8-week safety follow-up period. |
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| Part 3 (Dose/Frequency/Pharmacodynamic (PD) Relationship): Dose Level 1: RO7126209 | Experimental | Participants will receive multiple doses of RO7126209 in an open-label treatment period at dose level 1, Q4W, for 24 weeks followed by a 28-week safety follow-up period. |
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| Part 3 Dose/Frequency/PD Relationship: Dose Level 2: RO7126209 | Experimental | Participants will receive multiple doses of RO7126209 in an open-label treatment period at dose level 2, Q12W, for 24 weeks followed by a 28-week safety follow-up period. |
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| Part 4: Open Label Extension (OLE) | Experimental | Participants who completed Part 1, 2, or 3 will receive RO7126209 for a maximum of 205 weeks. |
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| Placebo | Drug | RO7126209-matching placebo will be administered intravenously as specified in each treatment arm. |
|
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| Part 1, 2, 3, and 4: Cerebral Spinal Fluid (CSF) Concentration of RO7126209 | Part 1 and 2: Up to approximately 25 weeks; Part 3: Up to approximately 21 weeks; Part 4: Up to approximately 205 weeks |
| Part 1, 2, 3, and 4: Number of Participants With Anti-Drug Antibodies (ADAs) to RO7126209 | Part 1 and 2: Up to approximately 56 weeks; Part 3: Up to approximately 52 weeks; Part 4: Up to approximately 233 weeks |
| Clermont |
| Florida |
| 34711 |
| United States |
| K2 Medical Research - The Villages | Lady Lake | Florida | 32159 | United States |
| K2 Medical Research, LLC | Maitland | Florida | 32751 | United States |
| Optimus U Corp | Miami | Florida | 33135 | United States |
| Charter Research - Winter Park/Orlando | Orlando | Florida | 32803 | United States |
| Advent Health Orlando | Orlando | Florida | 32804 | United States |
| Alzheimer's Research and Treatment Center | Stuart | Florida | 34996 | United States |
| Charter Research - Lady Lake/The Villages | The Villages | Florida | 32162 | United States |
| Alzheimer?s Research and Treatment Center | Wellington | Florida | 33414 | United States |
| Conquest Research, LLC | Winter Park | Florida | 32789 | United States |
| Alzheimer's Research and Treatment Center - Columbus | Columbus | Georgia | 31904 | United States |
| Center for Advanced Research & Education | Gainesville | Georgia | 30501 | United States |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | United States |
| Summit Research Network Inc. | Portland | Oregon | 97210 | United States |
| Abington Neurological Associates | Abington | Pennsylvania | 19001 | United States |
| Kerwin Research Center, LLC | Dallas | Texas | 75231 | United States |
| Heidelberg Repatriation Hospital | Heidelberg West | Victoria | 3081 | Australia |
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Richmond Clinical Trials | Richmond | British Columbia | V6V 2L1 | Canada |
| Toronto Memory Program | Toronto | Ontario | M3B 2S7 | Canada |
| Centro de Investigación Clínica UC-CICUC | Santiago | 8330034 | Chile |
| Hospital Clinico Univ de Chile | Santiago | 8380456 | Chile |
| Yokohama City Minato Red Cross Hospital | Kanagawa | 231-8682 | Japan |
| Koseikai Takeda Hospital | Kyoto | 600-8558 | Japan |
| National Hospital Organization Utano National Hospital | Kyoto | 616-8255 | Japan |
| Keio University Hospital | Tokyo | 160-8582 | Japan |
| Tokyo Metropolitan Institute for Geriatrics and Gerontology | Tokyo | 173-0015 | Japan |
| Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital | Tokyo | 190-8531 | Japan |
| Osrodek Badan Klinicznych Euromedis | Szczecin | 70-111 | Poland |
| NZOZ WCA | Wroc?aw | 53-659 | Poland |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital General De Catalunya | Sant Cugat del Vallès | Barcelona | 8195 | Spain |
| Policlínica Guipuzcoa | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Fundación ACE | Barcelona | 08028 | Spain |
| Hospital Clinic i Provincial | Barcelona | 08036 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Dr. Peset | Valencia | 46017 | Spain |
| Hospital Universitario la Fe | Valencia | 46026 | Spain |
| UCL Institute of Neurology | London | WC1N 3BG | United Kingdom |
| 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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