LY4006895 for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Eli Lilly and Company

Must not be taking: Anti-tau, Amyloid therapies

Disqualifiers: Serious illnesses, Suicidal, Drug abuse, others

Trial Summary

What is the purpose of this trial?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 in healthy participants or Part B will administer multiple-ascending doses in participants with early symptomatic Alzheimer's Disease (AD). Blood tests will be performed to check how much LY4006895 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and will last approximately 29 weeks for Part A and 61 weeks for Part B, including a screening period for each part.

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.

Eligibility Criteria

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

+1 more

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

+6 more

Trial Timeline

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

Participant Groups

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.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: LY4006895 of Part B (MAD)Experimental Treatment1 Intervention

Multiple-ascending doses of LY4006895 will be administered IV

Group II: LY4006895 of Part A (SAD)Experimental Treatment1 Intervention

Single-ascending doses of LY4006895 administered intravenously (IV)

Group III: Placebo Part APlacebo Group1 Intervention

Placebo administered IV

Group IV: Placebo Part BPlacebo Group1 Intervention

Placebo administered IV