Cognitive Dysfunction, Lewy Body Disease, Synucleinopathies, Amyloid
Conditions
Keywords
Mild Cognitive Impairment, Mild Dementia, Brain Diseases, Nervous System Diseases, Neurodegenerative Diseases, Neurocognitive Disorders, Cognition Disorders, Alzheimer Disease, Cognitive Dysfunction
Brief summary
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.
Interventions
DRUGDonanemab
Donanemab administered IV
DRUGPlacebo
Placebo administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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. * Have previously received amyloid-targeting therapy. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB) | Baseline through Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline for Integrated Alzheimer's Disease Rating Scale (iADRS) | Baseline through Week 52 |
| Change from Baseline for Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13 items (ADAS-Cog13) | Baseline through Week 52 |
| Change from Baseline for Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living Inventory (ADCS-iADL) | Baseline through Week 52 |
| Time to Clinical Progression of Dementia as Measured by Clinical Dementia Rating - Global Score (CDR-GS) | Baseline through Week 52 |
| Change from Baseline in Brain Amyloid Plaque Levels | Baseline through Week 52 |
| Trough Concentration at Steady State | Baseline through Week 52 |
| Maximum Concentration at Steady State | Baseline through Week 52 |
| Antidrug Antibodies (ADA) Against Donanemab | Baseline through Week 52 |
| Frequency of Neutralizing Antibodies to Donanemab Treatment-Emergent ADA-Positive Participants | Baseline through Week 52 |
Countries
Japan, South Korea, Taiwan, United States
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