Alzheimer Disease, Dementia, Plaque, Amyloid
Conditions
Keywords
Donanemab
Brief summary
The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses. For each participant, the study will last up to 2.5 years and will include 6 visits.
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, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have completed study AACM Addendum 7. * Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities. * Are individuals assigned female at birth who are not of childbearing potential, or are individuals assigned male at birth. * Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria
* Current serious or unstable illnesses that, in the investigator's opinion, could interfere with participation in this study. * Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker. * Have any intracranial abnormality or lesion, including but not limited to macrohemorrhage, inflammation, or structural findings that, in the opinion of the investigator, may pose an unacceptable safety risk to the participant. Screening MRI finding of amyloid-related imaging abnormalities with edema (ARIA-E) may be monitored for resolution. * Contraindication to florbetapir F 18 PET. * Have had history of amyloid-targeting therapy treatment outside donanemab trials. * Have participated, within the last 30 days, in a clinical trial involving a study intervention judged not to be scientifically or medically compatible with this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB) | Baseline through Week 130 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline as Measured by Cognitive Function Index (CFI) | Baseline through Week 130 |
| Change from Baseline in Brain Amyloid Plaque Levels as Measured by Florbetapir F 18 Positron Emission Tomography (PET) Scan. | Baseline through Week 130 |
| Change From Baseline in Plasma Phosphorylated Tau at Threonine 217 (P-tau217) | Baseline through Week 130 |
| Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab | Baseline, Week 52, Week 104 |
Countries
Puerto Rico, 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