A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age55+
SponsorEli Lilly and Company
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Donanemab
DrugAdministered IV
Placebo
DrugAdministered IV
Treatment groups
550 Participants
are divided into 2 treatment groupsGroup A: DonanemabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Time frame
Baseline through Week 130Secondary outcomes
1
Change from Baseline as Measured by Cognitive Function Index (CFI)
Time frame
Baseline through Week 1302
Change from Baseline in Brain Amyloid Plaque Levels as Measured by Florbetapir F 18 Positron Emission Tomography (PET) Scan.
Time frame
Baseline through Week 1303
Change From Baseline in Plasma Phosphorylated Tau at Threonine 217 (P-tau217)
Time frame
Baseline through Week 1304
Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab
Time frame
Baseline, Week 52, Week 104Sponsors and contacts
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Source ClinicalTrials.gov