What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and NMDA receptor antagonists (memantine). Cholinesterase inhibitors can cause gastrointestinal issues (nausea, vomiting, diarrhea), muscle cramps, fatigue, and insomnia. Memantine may lead to dizziness, headache, confusion, and constipation. Aducanumab, a newer treatment targeting amyloid plaques, has been associated with amyloid-related imaging abnormalities (ARIA), headache, falls, diarrhea, and confusion. These side effects should be discussed with a healthcare provider to manage and mitigate risks.

What prior FDA approvals exist?

Several FDA-approved treatments for Alzheimer's Disease target amyloid plaques, tau proteins, or neurotransmitter systems. Aducanumab, an anti-amyloid monoclonal antibody, targets amyloid plaques and was approved for Alzheimer's treatment. Other drugs like donepezil and galantamine are acetylcholinesterase inhibitors that enhance neurotransmitter systems by increasing acetylcholine levels. Memantine, another approved drug, works as an NMDA receptor antagonist to regulate glutamate activity. These treatments aim to modify disease progression or alleviate symptoms by targeting key pathological features of Alzheimer's Disease.

What other types of research exist?

Promising novel alternatives to LY3372689 for Alzheimer's Disease treatment in 2024 include: <ol> <li>Antisense Oligonucleotides (ASOs) targeting tau proteins, such as those studied in recent trials.</li> <li></li> </ol> Aducanumab, an antibody that targets amyloid plaques, which has been approved by the FDA. 3. Lecanemab, another monoclonal antibody targeting amyloid-beta, currently in late-stage clinical trials. 4. Donanemab, which targets a modified form of amyloid-beta and has shown positive results in clinical trials. 5. Blarcamesine (Anavex 2-73), which modulates sigma-1 and muscarinic receptors, showing potential neuroprotective effects.

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Monoclonal Antibodies

LY3372689 for Alzheimer's Disease

Phase 2

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

Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 76 to 124 weeks

Summary

This trial is testing a new drug, LY3372689, on people with early symptoms of Alzheimer's Disease to see if it is safe and how it affects their symptoms.

Who is the study for?

This trial is for people with early symptomatic Alzheimer's Disease, who have experienced a gradual memory decline for at least 6 months. Participants should score between 22 to 30 on the MMSE (a cognitive test) and meet specific criteria on a PET brain scan. They need a study partner willing to consent as well.

What is being tested?

The trial is testing LY3372689, which is being investigated for safety and effectiveness in treating Alzheimer's. Participants will either receive LY3372689 or a placebo without knowing which one they are getting to compare results fairly.

What are the potential side effects?

While the side effects of LY3372689 aren't detailed here, common side effects in trials like this may include allergic reactions, headaches, nausea, or other drug-related issues that will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My memory has been getting worse for at least 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 76 to 124 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 76 to 124 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 76 to 124 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline to End Time Point in Integrated Alzheimer's Disease Rating Scale (iADRS)

Secondary study objectives

Change From Baseline to End Time Point in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)

Change from Baseline to End Time Point in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)

Change from Baseline to End Time Point in Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living Inventory (ADCS-iADL)

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3372689 Low DoseExperimental Treatment1 Intervention

LY3372689 given orally

Group II: LY3372689 High DoseExperimental Treatment1 Intervention

LY3372689 given orally

Group III: PlaceboPlacebo Group1 Intervention

Placebo given orally

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3372689

2020

Completed Phase 1

~100

0 / 1Eligibility 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 often target amyloid plaques, tau proteins, and neurotransmitter systems. Amyloid-targeting therapies, like aducanumab, aim to reduce amyloid-beta plaques in the brain, which are believed to contribute to neurodegeneration. Tau protein-targeting treatments focus on preventing the formation of neurofibrillary tangles, another hallmark of Alzheimer's pathology. Neurotransmitter-based therapies, such as acetylcholinesterase inhibitors (donepezil, galantamine) and NMDA receptor antagonists (memantine), work by enhancing cholinergic function and regulating glutamate activity, respectively, to improve cognitive function. These mechanisms are crucial as they address the underlying pathophysiological processes of Alzheimer's, potentially slowing disease progression and improving quality of life for patients.