A Phase 1, Open Label, Multiple-Dose Study to Assess the Changes in Cerebrospinal Fluid Biomarkers for Alzheimer’s Disease Following Treatment with LY3439539 in Participants with Symptomatic Alzheimer’s Disease (NCT07598370)

A Phase 1, Open Label, Multiple-Dose Study to Assess the Changes in Cerebrospinal Fluid Biomarkers for Alzheimer’s Disease Following Treatment with LY3439539 in Participants with Symptomatic Alzheimer’s Disease

Trial phase

Phase 1

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

A/Prof David Darby

Key inclusion data

INCLUSION: Age 1. Participants must be 50 to 85 years of age inclusive, at the time of signing the informed consent. Type of participant and disease characteristics 2. Have gradual and progressive change in memory function reported by the participant or informant for 6 months or longer, consistent with a diagnosis of dementia due to AD based on Revised criteria according to the Alzheimer’s Association Workgroup (Jack et al. 2024) 3. Have a Mini Mental Score Examination score of 16 to 24, inclusive 4. Meet plasma pTau criteria, as defined by the sponsor Weight 5. Have body mass index within the range of 17 and 32 kg/m2 (inclusive) at screening. Sex and contraceptive/barrier requirements 6. Are women not of childbearing potential and men willing to practice effective contraception throughout the study. See Appendix 10.4 for definitions. Contraceptive use by participants should be consistent with local regulations regarding the Page 2 methods of contraception for those participating in clinical studies. For the contraception requirements of this protocol, see Appendix 10.4. Informed consent 7. Are capable of giving signed informed consent, as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. EXCLUSION: Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker. 12. Have a screening MRI that shows evidence of significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact the participant’s ability to safely participate in the study in the opinion of the investigator. 13. Have history of suicidal behavior, or a lifetime history of suicide attempt, such that a determination of “yes” is made on the Suicidal Behavior section of the C-SSRS for “actual attempt,” “interrupted attempt,” “aborted attempt,” or “preparatory acts or behavior.” 14. Have acute suicidality, as evidenced by answering “yes” for Question 4 or Question 5 on the C-SSRS, indicative of active suicidal ideation with any intent to act at screening or baseline. 15. Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation or an amount deemed significant by the investigator. 16. Regularly use known drugs of abuse, show positive findings on urinary drug screening that cannot be explained by regular concomitant medications, or both. 17. Show evidence of human immunodeficiency virus infection, positive human immunodeficiency virus antibodies, or both. 18. Have a positive HCV antibody test. Participants with a positive HCV antibody test at screening can be included only if a confirmatory HCV RNA test is negative. 19. Show evidence of hepatitis B, positive hepatitis B surface antigen, or both.