Donanemab for early memory and thinking decline with Lewy body features
Tests donanemab against placebo in people with early cognitive decline and Lewy body features.
Plain-language title generated from the registry record
Registry title: A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
Key facts
- Where
- Bunkyō City, Fujisawa, Himeji, Inage, Kawasaki, Kobe, Kōtoku, Kurashiki, Nagoya, Ōbu, Suita, tabashi City, Tachikawa, Toride, Yokohama, and Yufu, JapanSee the 18 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 85 years old?
Source: NCT07589595, who can take part
Where in Japan
- Memory Clinic OchanomizuBunkyō City, JapanTaking people
- Shonan Keiiku HospitalFujisawa, JapanTaking people
- Hyogo Prefectural Harima-Himeji General Medical CenterHimeji, JapanTaking people
- Inage Neurology and Memory ClinicInage, JapanTaking people
- Nippon Medical School Musashi Kosugi HospitalKawasaki, JapanNot yet recruiting
- St. Marianna University HospitalKawasaki, JapanNot yet recruiting
- Kobe University HospitalKobe, JapanTaking people
- Juntendo Tokyo Koto Geriatric Medical CenterKōtoku, JapanNot yet recruiting
- KATAYAMA medical ClinicKurashiki, JapanTaking people
- Nagoya Ekisaikai HospitalNagoya, JapanTaking people
- Nagoya University HospitalNagoya, JapanNot yet recruiting
- National Center for Geriatrics and GerontologyŌbu, JapanTaking people
- The University of Osaka HospitalSuita, JapanNot yet recruiting
- Tokyo Metropolitan Institute for Geriatrics and Gerontologytabashi City, JapanNot yet recruiting
- Tachikawa HospitalTachikawa, JapanTaking people
- Memory Clinic TorideToride, JapanTaking people
- Yokohama Minami Kyosai HospitalYokohama, JapanTaking people
- Oita University HospitalYufu, JapanNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07589595
- Record updated
- 4 November 2026
- Original description
The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.Read full original descriptionShow less
A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology
The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.
Inclusion: Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months; Have least 1 core clinical feature of dementia with Lewy bodies (DLB); Have a score ≥20 on Montreal Cognitive Assessment (MoCA); Meet plasma P-tau217 criteria; Have a cerebrospinal fluid (CSF) result consistent with the presence of brain amyloid pathology; Have a CSF result consistent with the presence of alpha-synuclein pathology; Have at least 1 reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant, and is familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
Exclusion: Have previously received amyloid-targeting therapy; Have a disease or condition that could interfere with this study or is a current serious or unstable illness; Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study; Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study; Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions; Active immunization against amyloid-beta; Have a centrally read MRI that does not meet study entry criteria; Have contraindication to MRI or PET scans; Have any contraindication to lumbar puncture.