jRCT2031240502Active, not recruitingNot Applicable
A Study of Remternetug Versus Placebo in Early Alzheimer's Disease Participants at Risk for Cognitive and Functional Decline (J1G-MC-LAKI)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly Japan K.K.
- Enrollment
- 1,200
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 55age old over to 80age old under (—)
- Sex
- All
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
- •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.
Outcomes
Primary Outcomes
-
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
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