LY3372689 for Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, LY3372689, to determine its safety and effectiveness for individuals with early symptoms of Alzheimer's disease. Participants will take either the drug or a placebo (a pill with no active ingredient) daily for up to 124 weeks. The goal is to assess the drug's impact on memory and cognitive function. It suits those who have experienced gradual memory changes for at least six months and have a reliable study partner willing to participate. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that LY3372689 is generally safe based on earlier studies. In tests with healthy participants, LY3372689 was well-tolerated, with no serious side effects reported from either single or multiple doses. These studies provide some confidence about its safety for individuals with Alzheimer's disease.12345
Why do researchers think this study treatment might be promising for Alzheimer's?
Researchers are excited about LY3372689 because it offers a new approach to treating Alzheimer's disease. Unlike most current treatments, which primarily focus on managing symptoms, LY3372689 is designed to target underlying disease mechanisms. This drug acts on specific pathways in the brain that are believed to contribute to Alzheimer's progression, offering hope for slowing or altering the course of the disease rather than just alleviating symptoms. Additionally, LY3372689 is administered orally, making it a convenient option for patients.
What evidence suggests that LY3372689 might be an effective treatment for Alzheimer's Disease?
Research shows that LY3372689, also known as ceperognastat, is under study for its potential to aid in early Alzheimer's disease. LY3372689 targets an enzyme called O-GlcNAcase, believed to be important for brain health. Early results suggest it could slow the worsening of Alzheimer's symptoms. While specific data on LY3372689's effectiveness is still being gathered, it builds on promising strategies used in other Alzheimer's treatments. More research is needed to confirm its benefits, but scientists consider this approach promising.16789
Who Is on the Research Team?
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)
Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive LY3372689 or placebo orally to assess safety, tolerability, and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY3372689
- Placebo
Trial Overview
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.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks
Participants received placebo administered orally once daily for up to 124 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Citations
A Study of LY3372689 to Assess the Safety, Tolerability, ...
The purpose of this study is to assess the safety, tolerability and effect of study drug LY3372689 in participants with early symptomatic Alzheimer's Disease.
Clinical trials of new drugs for Alzheimer disease
In the TRAILBLAZER-ALZ study, donanemab slowed disease progression by 32% at 18 months (p = 0.04 vs. placebo), thus demonstrating clinical efficacy [51].
A Study of LY3372689 to Assess the Safety, Tolerability, and ...
Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex ...
Discovery and clinical translation of ceperognastat, an O ...
A multidisciplinary approach was used to identify ceperognastat (LY3372689) as a potent OGA inhibitor, including an extensive discovery effort.
Ceperognastat
Ceperognastat (LY3372689) is a drug candidate molecule under investigation to treat Alzheimer's disease. It targets the enzyme O-GlcNAcase.
Discovery and clinical translation of ceperognastat, an O ...
Ceperognastat had an acceptable safety profile in Phase 1 clinical studies. Keywords: Alzheimer's disease; O‐GlcNAcase inhibition; O‐ ...
A Study of LY3372689 to Assess the Safety, Tolerability, and ...
The purpose of this study is to assess the safety, tolerability and effect of study drug LY3372689 in participants with early symptomatic Alzheimer's Disease.
8.
alz-journals.onlinelibrary.wiley.com
alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.057728Single and multiple ascending dose studies in healthy ...
LY3372689 demonstrated an acceptable safety and PK profile following single and multiple doses of LY3372689 in HV. These results support ...
9.
trial.medpath.com
trial.medpath.com/clinical-trial/c138f1bb6034851f/euctr2021-000170-29-pl-safety-tolerability-efficacy-ly3372689-alzheimers-diseaseAssessment of Safety, Tolerability, and Efficacy of (LY3372689 ...
•Gradual and progressive change in memory function reported by participants or informants for = 6 months •MMSE score of 22 to 30 (inclusive) at baseline
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