Alzheimer Disease
Conditions
Brief summary
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.
Interventions
DRUGDonanemab
Administered IV
DRUGPlacebo
Administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
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: * Provides written informed consent to participate in the study in their role * Has frequent contact with the participant and is familiar with their overall function and behavior, including daily activities and cognitive abilities * Is of legal age (18 years of age or older) to consent * Is available to conduct functional scales * Have adequate literacy, vision, and hearing for neuropsychological testing
Exclusion criteria
* Have mild cognitive impairment (MCI), dementia, or other significant neurodegenerative diseases that could affect cognition * Have a serious or unstable illness (including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease, or other condition) that, in the investigator's opinion, could interfere with study analyses or result in a life expectancy of 5 years or fewer * Have received active or passive immunization against amyloid beta (Aβ) in any other study * Have current or prior use of prescription medications for treatment of MCI or AD * Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants or other accessory medical devices, such as cardiac pacemakers, stents, and cochlear implants * Have a centrally read magnetic resonance imaging (MRI) demonstrating the presence of Amyloid-related imaging abnormalities (ARIA-E), more than 4 cerebral microhemorrhages, more than 1 area of cortical superficial siderosis, any macrohemorrhage (that is, intracerebral hemorrhage more than 1 cm), or severe white matter disease at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS) | Baseline Up to Week 156 |
Secondary
| Measure | 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 |
| Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab | Baseline Up to Week 156 |
| PK: Trough Concentrations of Serum Donanemab | Baseline Up to Week 156 |
Countries
China
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 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
Outcome results
None listed