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Monoclonal Antibodies

LY3372993 for Alzheimer's Disease

Phase 1
Waitlist Available
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
(Part B) Overtly healthy males or females
(Part B) Have a body mass index of 18.0 to 32.0 kg/m2, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 predose through week 61 (part a) and week 13 (part b)
Awards & highlights

Study Summary

This trial is testing a new drug, LY3372993, for safety and tolerability in Alzheimer's patients and healthy first-generation Japanese people. The study will last up to 61 weeks and include up to 31 visits to the study center.

Who is the study for?
This trial is for adults with Alzheimer's Disease (AD) showing memory decline for over 6 months and healthy individuals, including those of first-generation Japanese origin. AD participants need a partner to assist during the study. Healthy subjects must be within certain body weight limits and not on recent medications.Check my eligibility
What is being tested?
The safety and effects of LY3372993 are being tested in two parts: one with Alzheimer's patients and another with healthy people, possibly including first-generation Japanese individuals. The study will measure how much drug gets into the blood and its impact on participants.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones may include reactions at injection sites, headaches, nausea, or other symptoms that can vary widely among individuals based on their health status.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am generally in good health.
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My BMI is between 18.0 and 32.0.
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I have been experiencing worsening memory issues for over 6 months and have been diagnosed with mild cognitive impairment or Alzheimer's dementia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 predose through week 61 (part a) and week 13 (part b)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 predose through week 61 (part a) and week 13 (part b) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Secondary outcome measures
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3372993
Pharmacodynamics (PD): Change from Baseline in Cerebral Amyloid Plaque Level (Part A only)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3372993

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3372993 (Part B)Experimental Treatment1 Intervention
LY3372993 administered as single dose IV or SC.
Group II: LY3372993 (Part A)Experimental Treatment1 Intervention
LY3372993 administered as multiple doses either intravenously (IV) or subcutaneously (SC).
Group III: Placebo (Part A)Placebo Group1 Intervention
Placebo administered as multiple doses IV or SC.
Group IV: Placebo (Part B)Placebo Group1 Intervention
Placebo administered as single dose IV or SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3372993
2018
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,200,705 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
405,028 Total Patients Enrolled

Media Library

LY3372993 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04451408 — Phase 1
Alzheimer's Disease Research Study Groups: LY3372993 (Part B), Placebo (Part A), LY3372993 (Part A), Placebo (Part B)
Alzheimer's Disease Clinical Trial 2023: LY3372993 Highlights & Side Effects. Trial Name: NCT04451408 — Phase 1
LY3372993 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04451408 — Phase 1
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT04451408 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the inclusion criteria for this trial limited to those under 65 years of age?

"According to the specification, potential participants for this clinical trial must be between 18 and 85 years old. However, if you are below 18 or above 65 there are 73 trials available specifically targeting minors and 899 studies focusing on geriatric patients respectively."

Answered by AI

Who is eligible to enroll in this clinical experiment?

"To qualify for this clinical trial, individuals must have alzheimer disease and be of age between 18-85. Aspiring participants should note that 224 patients are being recruited in total."

Answered by AI

How many medical locations are offering this clinical trial?

"WCCT Global in Cypress, BioClinica Inc in Orlando and Progressive Medical Research in Port Orange are three of the thirteen medical centres currently participating. In addition to these sites, there are 10 other locations operating across the country."

Answered by AI

Are there any open enrollment opportunities for this clinical experiment?

"Correct. Clinicaltrials.gov has verified that this medical trial is actively accepting new participants, having initially been posted on July 7th 2020 and updated as recently as September 8th 2022. Currently, 224 patients need to be recruited from 13 different sites for the study's completion."

Answered by AI

Is LY3372993 an appropriate therapeutic solution with minimal risks?

"The safety of the drug LY3372993 has been rated as a 1, based on limited data from its Phase 1 trial and supporting evidence for efficacy."

Answered by AI

How many participants are currently partaking in this research trial?

"Confirmed. Details available on clinicaltrials.gov demonstrate that this research trial is actively recruiting participants, beginning with the initial posting date of July 7th 2020 and most recently being revised on September 8th 2022. 13 medical sites are involved in the recruitment process for a total target enrollment of 224 patients."

Answered by AI

Who else is applying?

What state do they live in?
California
Florida
What site did they apply to?
Collaborative Neuroscience Research, LLC
Charter Research
BioClinica Inc
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I live in The Villages, 62 years old, M, healthy, excercise regularly.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of LY3372993 in Participants With Alzheimer's Disease (AD) and Healthy Participants
2020. "A Study of LY3372993 in Participants With Alzheimer's Disease (AD) and Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04451408.
All > Alzheimer Disease > Alzheimers Disease
~18 spots leftby Aug 2024
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