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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 you been noticing a gradual decline in your memory or other thinking-related functions for more than 6 months?
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 52
Awards & highlights
Pivotal Trial
Summary
This trial tests remternetug, a drug given by injection or IV, in people with early Alzheimer's disease. It aims to find out if the drug is safe and can help improve symptoms or slow down the disease.
Who is the study for?
This trial is for individuals with early Alzheimer's who've noticed memory or cognitive decline over 6+ months. They need a reliable partner to assist with the study, must not have other neurological diseases affecting cognition, and should be able to undergo neuropsychological testing.
What is being tested?
The study tests Remternetug's safety and effectiveness in treating early Alzheimer's disease. Participants will receive either a placebo or Remternetug through subcutaneous (SC) injections or intravenous (IV) infusions.
What are the potential side effects?
While specific side effects of Remternetug are not listed here, common side effects in trials may include injection site reactions, fatigue, nausea, and potential allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have experienced a decline in memory or thinking for over 6 months.
Select...
I am committed to following the study's schedule and procedures.
Select...
Do you have a friend or family member who can help you with study visits and answer questions about your health?
Select...
I do not have a neurological condition affecting my memory, excluding Alzheimer's or dementia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo
Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)
Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo
+2 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Remternetug (SC)Experimental Treatment1 Intervention
Participants will receive one of two dosing regimens of remternetug subcutaneously (SC)
Participants will receive remternetug SC during the treatment period, then switch to placebo SC in the extension period.
Group II: Remternetug (IV)Experimental Treatment1 Intervention
Participants will receive remternetug intravenously (IV)
Participants will receive remternetug IV during the treatment period, then switch to placebo IV in the extension period.
Group III: Open-Label Addenda Remternetug (SC)Experimental Treatment1 Intervention
Participants will receive one of two dosing regimens of remternetug SC during the open-label addenda.
Group IV: Open-Label Addenda Remternetug (IV)Experimental Treatment1 Intervention
Participants will receive one of three dosing regimens of remternetug IV during the open-label addenda.
Group V: PlaceboPlacebo Group1 Intervention
Participants will receive placebo matching remternetug IV or SC.
Participants will receive placebo IV during the treatment period, then switch to remternetug IV in the extension period.
Participants will receive placebo SC during the treatment period, then switch to LY3372993 SC in the extension period.
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,651 Previous Clinical Trials
3,223,867 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,369 Previous Clinical Trials
420,794 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a positive result for P-tau, which shows the presence of amyloid protein in your body.I am a woman who cannot become pregnant.I am either male or female.You have a score between 20 to 28 on a test that measures your memory and thinking abilities.You have a positive amyloid PET scan indicating the presence of amyloid in the brain.I am committed to following the study's schedule and procedures.Do you have a friend or family member who can help you with study visits and answer questions about your health?I have experienced a decline in memory or thinking for over 6 months.I have someone who can support me during the study and is willing to provide consent.You are able to read, see, and hear well enough to complete the required neuropsychological testing, according to the investigator's judgement.I do not have a neurological condition affecting my memory, excluding Alzheimer's or dementia.
Research Study Groups:
This trial has the following groups:- Group 1: Open-Label Addenda Remternetug (SC)
- Group 2: Remternetug (SC)
- Group 3: Open-Label Addenda Remternetug (IV)
- Group 4: Remternetug (IV)
- Group 5: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05463731 — Phase 3
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