LY4006895 for Alzheimer's Disease

Recruiting at 7 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Anti-tau, Amyloid therapies

Disqualifiers: Serious illnesses, Suicidal, Drug abuse, others

Compensation: Varies

Number of Visits: Unknown

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, LY4006895, to determine its safety and tolerability. It targets individuals with early symptoms of Alzheimer's Disease, such as noticeable memory problems for at least six months. The study consists of two parts: one for healthy participants receiving a single dose, and another for those with early Alzheimer's receiving multiple doses. Ideal candidates for Part B are those with early Alzheimer's who have up to two study partners for support. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently using an amyloid targeted therapy, you may need to stop, as current exposure to such therapies is an exclusion criterion for Part B.

Is there any evidence suggesting that LY4006895 is likely to be safe for humans?

Research shows that LY4006895 is being tested for safety and tolerability. As an early-phase study, the primary goal is to observe participants' reactions to the drug, including any side effects and how the body processes it. Since this is the first human trial of LY4006895, no previous safety data exists. However, as the study progresses, more information will be collected. Researchers will closely monitor participants for any adverse effects, prioritizing their health throughout the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's Disease?

Most treatments for Alzheimer's disease, like donepezil or memantine, work by managing symptoms rather than altering the disease's progression. But LY4006895 works differently, as it targets the underlying processes involved in Alzheimer's. Researchers are excited about LY4006895 because it is administered intravenously, which allows for precise dosage control and potentially more effective results. This approach might offer a new way to slow or modify the disease progression, providing hope for more significant therapeutic outcomes.

What evidence suggests that LY4006895 might be an effective treatment for Alzheimer's Disease?

Research is investigating LY4006895 as a potential treatment for early symptoms of Alzheimer's Disease. This trial includes different arms where participants may receive either single-ascending doses, multiple-ascending doses of LY4006895, or a placebo. The treatment aims to remove amyloid plaques in the brain, believed to be a major factor in Alzheimer's. Removing these plaques might help slow or improve the symptoms of the disease. While direct evidence on LY4006895's effectiveness in people is not yet available, its approach shows promise. Early studies with similar treatments have shown positive results in reducing amyloid plaques. As more research progresses, a clearer understanding of its potential as an effective treatment will emerge. ^{1 3 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 healthy individuals and those with early symptomatic Alzheimer's Disease. Participants will either receive a single dose (healthy participants) or multiple doses (Alzheimer's patients). The study checks organ function, medication levels in blood, and how the body processes the drug.

Inclusion Criteria

For Part A and Part B: Have a body mass index (BMI) within the range 18 to 40 kilogram per square meter (kg/m²)

For Part A and Part B: Are overtly healthy as determined by medical evaluation. Rescreening is not allowed in this study

For Part B: Have up to 2 reliable study partners who are in frequent contact with the participant (defined as at least 10 hours per week), one of whom at any one occasion: will accompany the participant to the study visits, will be available by telephone at designated times, and will provide a separate written informed consent to participate

Exclusion Criteria

For Part B: Have a sensitivity to florataucipir 18F

For Part A and Part B: Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide

For Part A and Part B: Regularly use known drugs of abuse and/or show positive findings on urinary drug screening that cannot be explained by regular concomitant medications

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Single-ascending doses of LY4006895 administered intravenously to healthy participants

29 weeks

Treatment Part B

Multiple-ascending doses of LY4006895 administered intravenously to participants with early symptomatic Alzheimer's Disease

61 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY4006895

Trial Overview LY4006895 is being tested against a placebo to assess its safety and tolerability. Part A involves healthy volunteers receiving one dose; Part B involves Alzheimer's patients getting several doses over an extended period.

How Is the Trial Designed?

Group I: LY4006895 of Part B (MAD) Experimental Treatment 1 Intervention

Multiple-ascending doses of LY4006895 will be administered IV

Group II: LY4006895 of Part A (SAD) Experimental Treatment 1 Intervention

Single-ascending doses of LY4006895 administered intravenously (IV)

Group III: Placebo Part A Placebo Group 1 Intervention

Placebo administered IV

Group IV: Placebo Part B Placebo Group 1 Intervention

Placebo administered IV

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/NCT06657768

A Study of LY4006895 in Healthy Participants With Early ... The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY4006895. Part A will administer a single-ascending dose ...

2. trials.lilly.com trials.lilly.com/en-US/trial/549035

A Study of LY4006895 in Healthy Participants With Early ... The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY4006895.

3. withpower.com withpower.com/trial/phase-1-alzheimer-disease-9-2024-bd950

LY4006895 for Alzheimer's Disease The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY4006895. Part A will administer a single-ascending dose ...

4. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/34458324/eli-lillys-promising-alzheimers-study-a-potential-game-changer/

Eli Lilly's Promising Alzheimer's Study: A Potential Game ... The study aims to assess the safety and tolerability of LY4006895, a potential treatment for early symptomatic Alzheimer's Disease (AD), ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10544555/

Clinical trials of new drugs for Alzheimer disease The primary outcome is the percentage of participants who achieve complete amyloid plaque clearance after 6 months for each treatment group, with clearance ...

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/549035

A Study of LY4006895 in Healthy Participants With Early ... The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY4006895. Part A will administer a single-ascending ...