Remternetug (SC) for Alzheimer's Disease

Neurology Consultants of Dallas, PA, Dallas, TX
Alzheimer's DiseaseRemternetug (SC) - Drug
Eligibility
60 - 85
All Sexes
What conditions do you have?
Select

Study Summary

This trial is to study the effects of a new drug, remternetug, in people with early Alzheimer's disease.

Eligible Conditions
  • Alzheimer's Disease

Video Summary

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

0 Primary · 5 Secondary · Reporting Duration: Up to Week 52

Baseline to Week 52
Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)
Pharmacokinetics (PK) Observed Trough Serum Concentration (Cmin) of Remternetug
Baseline, Week 24
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo
Up to Week 52
Amyloid
Week 24
Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5 Treatment Groups

Remternetug (SC)
1 of 5
Open-Label Addenda Remternetug (SC)
1 of 5
Remternetug (IV)
1 of 5
Open-Label Addenda Remternetug (IV)
1 of 5
Placebo
1 of 5

Experimental Treatment

Non-Treatment Group

600 Total Participants · 5 Treatment Groups

Primary Treatment: Remternetug (SC) · Has Placebo Group · Phase 3

Remternetug (SC)
Drug
Experimental Group · 1 Intervention: Remternetug (SC) · Intervention Types: Drug
Open-Label Addenda Remternetug (SC)
Drug
Experimental Group · 1 Intervention: Remternetug (SC) · Intervention Types: Drug
Remternetug (IV)
Drug
Experimental Group · 1 Intervention: Remternetug (IV) · Intervention Types: Drug
Open-Label Addenda Remternetug (IV)
Drug
Experimental Group · 1 Intervention: Remternetug (IV) · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 52

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,497 Previous Clinical Trials
3,152,919 Total Patients Enrolled
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1,278 Previous Clinical Trials
379,369 Total Patients Enrolled

Eligibility Criteria

Age 60 - 85 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are committed to participating in the study for the entire duration and will follow all the study procedures as instructed.
Have you been experiencing a slow decrease in your ability to remember things or think clearly for more than 6 months?
You don't have any current neurological disease except for Alzheimer's or dementia that may cause memory and thinking problems, such as Parkinson's disease.
Do you have a friend or family member who can help you with study visits and answer questions about your health?

Who else is applying?

What state do they live in?
Texas42.9%
Pennsylvania28.6%
New Hampshire14.3%
Other14.3%
How old are they?
18 - 65100.0%
What site did they apply to?
Neuro-Pain Medical Center25.0%
MedVadis Research Corporation25.0%
NeuroScience Research Center25.0%
Other25.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria40.0%
Met criteria60.0%
Why did patients apply to this trial?
  • "I have called a number of trials. Most recently this month for Simufilam but the screening tester said my MMSE score was to low at 12/30 to enter the study. My current clinics most recent MoCA score was 15/30. I am hoping to get in a trial for something that might help as I was diagnosed over 3 years ago and have a strong family history. I am other wise very physically healthy."
  • "I know that I have pre-clinical Alzheimer's but I do not know my MMSE score. I am in the process of getting my own neurologist to help me navigate the clinical trial space. I would like to participate in a preventative or early Alzheimer's trial. With all the new biomarkers available it makes defining early Alzheimer's more difficult - for example, do you have to have measured cognitive decline if you have elevated amyloid plaque in your brain and intermediate tau?"
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?"
How many prior treatments have patients received?
050.0%
125.0%
3+25.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.