Mevidalen for Alzheimer's Disease

Recruiting at 104 trial locations

Overseen By Gregory Kirk

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Must not be taking: CYP3A4 inhibitors, inducers

Disqualifiers: Childbearing potential, CNS disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: 24 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, mevidalen, to determine its effectiveness on symptoms of mild to moderate Alzheimer's disease, such as memory problems, daily activities, sleep, and anxiety. Researchers aim to assess the drug's safety and efficacy by administering different doses and comparing them to a placebo (a pill with no active drug). The trial suits individuals who have experienced memory issues for over six months that impact daily life and have a reliable person to assist them during the study. The trial lasts about 26 weeks and includes up to 14 visits. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use moderate or strong CYP3A4 inhibitors or inducers. It's best to discuss your medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have shown that mevidalen is well-tolerated by patients. Research suggests that this drug is generally safe and easily processed by the body. In animal tests, mevidalen increased wakefulness, indicating a potential effect on alertness. However, the current study remains in an early phase. While some safety information is available, further research is necessary to fully understand any possible side effects or risks for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard Alzheimer's treatments, which typically focus on managing symptoms through cholinesterase inhibitors and memantine, Mevidalen works differently by targeting the dopamine D1 receptor. This new mechanism of action has researchers excited because it could potentially enhance cognitive function and slow disease progression more effectively. Additionally, Mevidalen is administered orally, which is convenient for patients. Researchers believe this unique approach may offer a promising new avenue for treating Alzheimer's disease, setting it apart from existing therapies.

What evidence suggests that mevidalen might be an effective treatment for Alzheimer's?

Research suggests that mevidalen may improve symptoms in people with Alzheimer's disease. In animal studies, mevidalen helped animals stay awake longer and fall asleep later, indicating potential benefits for sleep problems often seen in Alzheimer's. Early human studies showed that mevidalen was safe and well-tolerated by participants. This treatment affects dopamine D1 receptors, which play a crucial role in thinking and memory. Although more research is needed, these early results are promising. Participants in this trial will receive either a low dose or high dose of mevidalen, or a placebo, to further evaluate its effectiveness and safety. ^{1 2 4 5 6}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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 individuals with mild to moderate Alzheimer's Disease dementia. Participants will be involved in the study for about 26 weeks and may need to attend up to 14 visits.

Inclusion Criteria

Have MMSE score of 13 to 24

Have eligible plasma P-tau or historical evidence of AD pathology

Have a reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant and will be available at designated times

Exclusion Criteria

Are individuals of childbearing potential

Have significant central nervous system or psychiatric disease, other than AD, that in the investigator's opinion may affect cognition or the ability to complete the study (e.g: head trauma, stroke, seizure disorder etc.)

I have heart or liver issues, like high blood pressure or heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mevidalen or placebo to evaluate efficacy and safety in Alzheimer's Disease

24 weeks

Up to 14 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mevidalen

Trial Overview The trial is testing Mevidalen, a new drug, against a placebo (a substance with no therapeutic effect) to see if it can improve cognition, daily activities, sleep quality, physical activity, and reduce irritability or anxiety in Alzheimer's patients.

How Is the Trial Designed?

Group I: Mevidalen (low dose) Experimental Treatment 1 Intervention

Mevidalen low dose administered orally.

Group II: Mevidalen (high dose) Experimental Treatment 1 Intervention

Mevidalen high dose administered orally.

Group III: Placebo Placebo Group 1 Intervention

Placebo administered orally.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06538116

NCT06538116 | A Study of Mevidalen (LY3154207) in ... The main purpose of this study is to look at how safe the study drug (mevidalen) is and whether it works to alleviate symptoms when given to people with mild ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8048550/

Safety, Tolerability, and Pharmacokinetics of Mevidalen ... Mevidalen demonstrated an acceptable safety, tolerability, and PK profile in healthy subjects to support further development in neuropsychiatric ...

3. trials.lilly.com trials.lilly.com/en-US/trial/524115

A Study of Mevidalen (LY3154207) in Participants ... - Lilly Trials The main purpose of this study is to look at how safe the study drug (mevidalen) is and whether it works to alleviate symptoms when given to people with mild ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0022356524002477

The Dopamine D1 Receptor Positive Allosteric Modulator ... Mevidalen promoted wakefulness in mice after prior sleep deprivation and delayed sleep onset by 5.5- and 15.2-fold compared with vehicle-treated animals.

5. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/mevidalen-hydroxybenzoate-eli-lilly-and-co-alzheimer-s-disease-likelihood-of-approval/

Mevidalen hydroxybenzoate by Eli Lilly and Co for ... Mevidalen hydroxybenzoate is under clinical development by Eli Lilly and Co and currently in Phase II for Alzheimer's Disease.

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/524115

A Study of Mevidalen (LY3154207) in Participants With ... The main purpose of this study is to look at how safe the study drug (mevidalen) is and whether it works to alleviate symptoms when given to people with ...