Health Trials

A Study of LY3439539 in Participants With Alzheimer's Disease

ConditionAlzheimer Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50-85
SponsorEli Lilly and Company

About this trial

The purpose of this study is to see how LY3439539 affects certain proteins found in the spinal fluid of participants with Alzheimer's disease.

Participation in the study will last approximately 9 months with visits about once a month.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 Alzheimer's disease

Have a Mini Mental Score Examination score of 16 to 24, inclusive

Meet plasma pTau criteria, as defined by the sponsor

Have body mass index within the range of 17 and 32 kilograms per square meter (kg/m²) (inclusive) at screening

Disqualifiers

Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.

Have a screening MRI that shows evidence of significant abnormality.

Have history of suicidal behavior, or a lifetime history of suicide attempt or acute suicidality.

Have a history of

Trial design

Design model

Single group

Treatments tested in this trial

  • LY3439539

    Drug

    Administered IV

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: LY3439539Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in Cerebrospinal Fluid (CSF) Neurofilament Light Chain (NfL)

Time frame
Baseline through end of the Follow-up Period (Week 24)

Secondary outcomes

1

Change from Baseline in Phospho-Tau (pTau)

Time frame
Baseline through end of the Follow-up Period (Week 24)
2

Change from Baseline in Plasma NfL

Time frame
Baseline through end of the Follow-up Period (Week 24)
3

Pharmacokinetics (PK) Maximum LY3439539 Serum Concentration (Cmax)

Time frame
Baseline through end of the Follow-up Period (Week 24)
4

PK: Minimum LY3439539 Serum Concentration (Cmin)

Time frame
Time Frame: Baseline through end of Follow up Period (Week 24)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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