Alzheimer's Disease
Conditions
Interventions
DRUG: Remternetug(Other Name: LY3372993)
Administered SC
DRUG: Placebo
Administered SC
[Study Arms]
Experimental: Remternetug
Remternetug administered subcutaneously (SC).
Interventions:
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have a phosphorylated tau (P-tau) result consistent with the presence of amyloid pathology. - Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities. - Have adequate literacy, vision, and hearing for neuropsychological testing at screening. - Have a Mini Mental Status Exam (MMSE) score consistent with no to minimal cognitive impairment. - Have a Functional Activities Questionnaire (FAQ) score consistent with no to minimal functional impairment. - If currently receiving medications as symptomatic treatment for AD, dose has been stable for at least 30 days before screening.
Exclusion criteria
Exclusion criteria: - Have dementia or significant other neurological disease that can affect cognition. - Have current serious or unstable illnesses that in the investigator's opinion, could interfere with the analyses of the study. - Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence. - Have a history of clinically significant multiple or severe drug allergies, or hypersensitivity reactions. - Have a clinically important laboratory test result or other abnormality as determined by investigator, prior to radomization, that could be detrimental to the participant or could compromise the study. - Have any contraindications for magnetic resonance imaging (MRI). - Have a centrally read MRI that does not meets study entry criteria. Prior or Current Therapies - Have ever had prior treatment with a passive anti-amyloid immunotherapy. - Have received active immunization against AB in any other study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate (CDR) [ Time Frame: Baseline to Time to Event up to Week 255 Time to clinically meaningful progression as measured by CDR. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage and degree of impairment across the continuum of early Alzheimer's Disease (AD). | — |
Countries
Japan, United States
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed