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| ID | Type | Description | Link |
|---|---|---|---|
| I5T-MC-AACW | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the effects of donanemab (LY3002813) versus placebo in Chinese participants who are at risk for decline of memory, language and physical ability to perform activities of daily living from Alzheimer's disease (AD).
The study drug will be administered intravenously (IV) (into a vein in the arm).
The study will last up to approximately 156 weeks, excluding screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donanemab | Experimental | Donanemab administered intravenously (IV) |
|
| Placebo | Placebo Comparator | Placebo administered IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donanemab | Drug | Administered IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS) | Baseline Up to Week 156 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Plasma Phosphorylated Tau at Threonine 217 (P-tau217) | Baseline, Week 52 | |
| Change From Baseline as Measured by Clinical Dementia Rating-Sum of Boxes (CDR-SB) | Baseline Up to Week 156 |
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Inclusion Criteria:
A Telephone Interview for Cognitive Status - Modified (TICS-M) score indicative of intact cognitive function (cut-off score of 35 or higher)
Clinical Dementia Rating-Global Score (CDR-GS) of 0
A plasma P-tau result consistent with amyloid pathology
A reliable study partner who:
Have adequate literacy, vision, and hearing for neuropsychological testing
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | 100191 | China |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication or approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Placebo |
| Drug |
Administered IV |
|
| Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab | Baseline Up to Week 156 |
| PK: Trough Concentrations of Serum Donanemab | Baseline Up to Week 156 |
| The First Hospital of Jilin University | Recruiting | Changchun | 100012 | China |
|
| Xiangya Hospital Central South University | Not yet recruiting | Changsha | 410008 | China |
|
| Sichuan Provincial People's Hospital | Recruiting | Chengdu | 610072 | China |
|
| 2nd Affiliated Hospital Chongqing Medical University | Not yet recruiting | Chongqing | 400010 | China |
|
| The First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | 400016 | China |
|
| Fujian Medical University Union Hospital | Not yet recruiting | Fuzhou | 350001 | China |
|
| Guangdong Provincial People's Hospital | Not yet recruiting | Guangzhou | China |
|
| Anhui Provincial Hospital | Recruiting | Hefei | 230036 | China |
|
| The Second Hospital of Jiaxing | Recruiting | Jiaxing | 314000 | China |
|
| Jinan Central Hospital | Recruiting | Jinan | 250100 | China |
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| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | 330038 | China |
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| Jiangsu Province Official Hospital | Not yet recruiting | Nanjing | 210008 | China |
|
| Nanjing Brain Hospital | Not yet recruiting | Nanjing | 210029 | China |
|
| Sir Run Run Hospital of Nanjing Medical University | Recruiting | Nanjing | 211166 | China |
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| The First Affiliated Hospital of Nanyang Medical College | Recruiting | Nanyang | 473061 | China |
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| Shanghai Sixth People's Hospital | Recruiting | Shanghai | 200030 | China |
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| Shanghai East Hospital | Recruiting | Shanghai | 200120 | China |
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| Renji Hospital Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | 200127 | China |
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| Huashan Hospital, Fudan University | Recruiting | Shanghai | 201107 | China |
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| Pudong New Area People's Hospital Shanghai | Recruiting | Shanghai | 201200 | China |
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| ShenZhen People's Hospital | Not yet recruiting | Shenzhen | 518020 | China |
|
| The First Hospital of Hebei Medical University | Recruiting | Shijiazhuang | 050031 | China |
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| Tianjin Medical University General Hospital | Recruiting | Tianjin | 300052 | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | 325027 | China |
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| Shaanxi provincial people's hospital | Recruiting | Xi'an | 710068 | China |
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| Xianyang Hospital of Yan'an University | Recruiting | Xianyang | 712000 | China |
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| Qinghai Provincial People's Hospital | Recruiting | Xining | 810007 | China |
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| Zigong First People's Hospital | Recruiting | Zigong | 643000 | China |
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| Zunyi First People's Hospital | Recruiting | Zunyi | 563002 | China |
|
| 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 |
|---|---|
| C000729112 | donanemab |
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