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Remternetug for Alzheimer's Disease
Phase 3
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a phosphorylated tau (P-tau) result consistent with the presence of amyloid pathology
Be older than 18 years old
Must not have
Have dementia or significant other neurological disease that can affect cognition
Have a centrally read MRI demonstrating presence of ARIA-E, >4 cerebral microhemorrhages, any superficial siderosis, any macrohemorrhage, or severe white matter disease at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 255
Awards & highlights
Pivotal Trial
Summary
This trial aims to see if a new drug can delay memory or thinking problems in Alzheimer's disease compared to a placebo. Participants will be in the study for up to 255 weeks, including treatment and
Who is the study for?
This trial is for individuals with early Alzheimer's disease who experience agitation and dementia. Participants should be willing to commit up to almost 5 years, including treatment and observation periods. Details on specific inclusion or exclusion criteria are not provided.
What is being tested?
The study tests Remternetug against a placebo to see if it can delay the progression of memory, thinking, or functional issues in Alzheimer's patients. It includes a double-blind phase where neither participants nor researchers know who gets the real drug or placebo.
What are the potential side effects?
Specific side effects of Remternetug are not listed here, but common ones for Alzheimer's treatments may include nausea, diarrhea, insomnia, muscle cramps, and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tests show signs of amyloid in my brain.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have dementia or a neurological condition affecting my thinking.
Select...
My MRI shows signs of brain bleeding or severe white matter disease.
Select...
I haven't had anti-amyloid immunotherapy recently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 255
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 255
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate (CDR)
Secondary study objectives
Change from Baseline in Alzheimer's Disease Cooperative Study (ADCS) Activities of Daily Living - Prevention Instrument (ADCS-ADL-PI)
Change from Baseline in Clinical Dementia Rate Box Score (SB)
Change from Baseline in Cognitive Function Index (CFI)
+9 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RemternetugExperimental Treatment1 Intervention
Remternetug administered subcutaneously (SC).
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered SC.
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,465,184 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
427,641 Total Patients Enrolled