NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease

RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Alzheimer Disease

Interventions: Donanemab, Placebo

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 55 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (30)

Beijing, China
Changchun, China
Changsha, China
Chengdu, China
Chongqing, China
Chongqing, China
Fuzhou, China
Guangzhou, China
Hefei, China
Jiaxing, China
Jinan, China
Nanchang, China
Nanjing, China
Nanjing, China
Nanjing, China
Nanyang, China
Shanghai, China
Shanghai, China
Shanghai, China
Shanghai, China
Shanghai, China
Shenzhen, China
Shijiazhuang, China
Tianjin, China
Wenzhou, China
Xi'an, China
Xianyang, China
Xining, China
Zigong, China
Zunyi, China