What side effects are associated with this type of intervention?

The most common treatments for Alzheimer's Disease include cholinesterase inhibitors (such as donepezil, rivastigmine, and galantamine) and memantine. Known side effects of cholinesterase inhibitors often include gastrointestinal issues like nausea, vomiting, and diarrhea, as well as muscle cramps and fatigue. Memantine, used for moderate to severe AD, can cause dizziness, headache, confusion, and constipation. LY3372993, currently under study, aims to evaluate similar safety and tolerability aspects, focusing on how the drug is absorbed and its effects on the body.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease, focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics. Aducanumab, an amyloid beta-directed antibody, was approved for its ability to reduce amyloid plaques in the brain, though it carries risks such as amyloid-related imaging abnormalities (ARIA). Additionally, vitamin E has been studied for its antioxidant properties, showing modest benefits in delaying functional progression with a favorable safety profile. These treatments aim to manage symptoms and slow disease progression, similar to the goals of the LY3372993 study.

What other types of research exist?

Promising novel alternatives to LY3372993 for Alzheimer's Disease treatment in 2024 include: 1) Lecanemab, an anti-amyloid beta protofibril antibody shown to reduce amyloid plaques and slow cognitive decline. 2) Donanemab, an antibody targeting a modified form of amyloid beta, which has demonstrated potential in slowing disease progression. 3) Aducanumab, an amyloid beta-directed antibody, approved by the FDA for reducing amyloid plaques in the brain. These alternatives focus on amyloid beta reduction and have shown varying degrees of efficacy and safety in clinical trials.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 predose through week 61 (part a) and week 13 (part b)

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease (AD) often target amyloid plaques, oxidative stress, and inflammation. Amyloid-targeting therapies, such as aducanumab, work by reducing amyloid-beta plaques in the brain, which are believed to contribute to AD pathology. Antioxidants like vitamin E aim to mitigate oxidative stress, which can damage neurons. Anti-inflammatory drugs attempt to reduce neuroinflammation, another factor implicated in AD progression. These mechanisms are crucial as they address different aspects of the disease's pathology, potentially slowing cognitive decline and improving quality of life for AD patients. LY3372993, being studied for its effects on AD, likely involves similar mechanisms, focusing on its safety and how it interacts with the body to provide therapeutic benefits.