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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
Study Summary
This trial is to study the effects of a new drug, remternetug, in people with early Alzheimer's 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
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 moreTrial 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
2,619 Previous Clinical Trials
3,205,998 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
405,144 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research rely on a geriatric patient base?
"According to the eligibility requirements for this clinical trial, the minimum age for participation is 60 and the maximum age is 85."
Answered by AI
How many individuals can join this research project?
"The pharmaceutical company Eli Lilly and Company is sponsoring a clinical trial that requires 400 individuals that meet the necessary inclusion criteria. The trial will take place in Columbus Memory Center, LLC in Columbus, Georgia and Summit Headlands in Portland, Oregon."
Answered by AI
Please tell us how many hospitals are participating in this experiment.
"There are many locations across the country where this trial is being conducted, some of which include Columbus Memory Center, LLC in Columbus, Georgia, Summit Headlands in Portland, Oregon, and The University of Texas Health Science Center at Houston in Sugar Land, Texas."
Answered by AI
Are we still taking volunteers for this research project?
"The online database clinicaltrials.gov indicates that this trial is actively recruiting patients. The listing was created on 8/1/2022 and was last updated on 10/17/2022."
Answered by AI
What is the official decision from the FDA about Remternetug (SC)?
"Remternetug (SC) is a Phase 3 trial medication, meaning that it has some efficacy data to support its safety, which our team at Power rates as a 3."
Answered by AI
If I meet the qualifications, may I join this clinical trial?
"This study, which is looking for 400 patients that suffer from Alzheimer's disease, has the following age requirement: 60-85. Most notably, candidates must meet the following criteria: Gradual and progressive change in cognitive function ≥6 months prior to screening., A Mini-Mental (MMSE) score of 20 to 28 (inclusive) at screening., Have a reliable study partner who will provide written informed consent to participate and is in frequent contact with the participant., Have adequate literacy, vision, and hearing for the neuropsychological testing in the opinion of the investigator at the time of screening., Are reliable and willing to make themselves available"
Answered by AI
Who else is applying?
What state do they live in?
Texas
Pennsylvania
New York
Other
How old are they?
18 - 65
What site did they apply to?
MedVadis Research Corporation
NeuroScience Research Center
The Cognitive and Research Center of New Jersey
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
Why did patients apply to this trial?
I was in a previous trial for Aducanumab. I’m concerned about progress of the disease.
PatientReceived no prior treatments
To see if the memory loss can be slowed down or stopped. I’m doing well with Nemantine and Doneprazil over past year, but am interested in increasing my options and possibilities.
PatientReceived no prior treatments
I have been a national speaker in my career, and taught. I now find that in talking to people I sometimes can’t find the right word or the name of a person. It is very frustrating. This is unlike me. I will be 80 years old in a couple of months, and I am a widow with no children. So I am trying to seriously take care of myself and my future needs.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
If the primary objective of the trial is reduced amyloid plaque then why does there need to be clinical evidence of cognitive decline. If I am diagnosed with pre-clinical Alzheimer's disease then do I have Alzheimer's?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- The Cognitive and Research Center of New Jersey: < 48 hours
Average response time
- < 2 Days
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