Alzheimer's Disease
Conditions
Brief summary
The purpose of this study is to measure the difference in time to developing or worsening memory, thinking, or functional problems due to Alzheimer's disease occurring in participants receiving study drug compared to placebo. Participation could last up to 255 weeks including screening, a double-blind treatment period, and a double-blind observation period. In addition, eligible participants who receive placebo during the double-blind treatment period may choose to extend their study participation to receive open-label remternetug in an extension period.
Interventions
DRUGRemternetug
Administered SC
DRUGPlacebo
Administered SC
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 80 Years
Healthy volunteers
No
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 randomization, 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 Aβ in any other study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate Scale (CDR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Montreal Cognitive Assessment (MoCA) | Baseline, Week 255 | Change from baseline in Montreal Cognitive Assessment (MoCA). Total MoCA score is 0 to 30, with lower scores indicating greater level of impairment. |
| Change from Baseline in the Category Fluency - Language, Executive Function, Semantic Memory | Baseline, Week 255 | Change from baseline in the Category Fluency - Language, Executive Function, Semantic Memory. The total score reflects the sum of correct responses generated across all categories presented, with higher values indicating better performance. |
| Change from Baseline in the Continuous Paired Associate Learning (CPAL) | Baseline, Week 255 | Change from baseline in Continuous Paired Associate Learning (CPAL) - Visual episodic memory. |
| Change from Baseline in International Shopping List Test (ISLT) - Verbal Episodic Mem | Baseline, Week 255 | Change from baseline in the International Shopping List Test (ISLT) - verbal episodic memory. |
| Change from Baseline in International Daily Symbol Substitution Test-Medicines (iDSSTm) - Complex Attention Memory | Baseline, Week 255 | Change from baseline in the International Daily Symbol Substitution Test-Medicines (iDSSTm) - complex attention memory. |
| Change from Baseline in Clinical Dementia Rate Box Score (SB) | Baseline, Week 255 | Change from baseline in Clinical Dementia Rate Box Score (SB) scores range from 0 to 18, with higher scores indicative of more impairment. |
| Change from Baseline in Mild Behavioral Impairment Checklist (MBI-C) | Baseline, Week 255 | Change from baseline in the Mild Behavioral Impairment Checklist (MBI-C) The MBI-C total score range is 0 to 102, with higher scores indicating greater impairment. |
| Change from Baseline in Alzheimer's Disease Cooperative Study (ADCS) Activities of Daily Living - Prevention Instrument (ADCS-ADL-PI) | Baseline, Week 255 | Change from baseline in the Activities of Daily Living - Prevention Instrument total scores range from 0 to 54, with higher scores indicating better performance. |
| Pharmacokinetics: Serum Concentrations of Remternetug | Baseline through Week 255 | PK: serum concentration of remternetug. |
| Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs) | Baseline through Week 255 | Number of participants with treatment emergent anti-drug antibodies (TE-ADAs). |
| Change from Baseline in Cognitive Function Index (CFI) | Baseline, Week 255 | Change from baseline in the Cognitive Function Index (CFI). |
Countries
Australia, Canada, China, Japan, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom, United States
Outcome results
None listed