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New treatment option for Alzheimer Disease
Official title Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease
ClinicalTrials.gov ID: NCT07571161
What this study is testing
What is Donanemab?
Donanemab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for alzheimer disease.
Also referred to as LY3002813.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 80
You may be able to join if
- 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
You likely can't join if
- 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...
- 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)...
- Have a centrally read magnetic resonance imaging (MRI) demonstrating the presence of Amyloid-related imaging abnormalities (ARIA-E), more than 4...
See the full eligibility 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
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Changchun, China
- Changsha, China
- Chengdu, China
- Chongqing, China
- Fuzhou, China
- Guangzhou, China
- Hefei, China
- Jiaxing, China
- Jinan, China
- Nanchang, China
- Nanjing, China
- Nanyang, China
- Shanghai, China
- Shenzhen, China
- Shijiazhuang, China
- Tianjin, China
- Wenzhou, China
- Xi'an, China
- Xianyang, China
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Changchun, China; Changsha, China; Chengdu, China; Chongqing, China; Fuzhou, China and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.