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Recruiting NCT07598370

A Study of LY3439539 in Participants With Alzheimer's Disease

Phase I Interventional Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LY3439539.
Who it may be relevant to
Registry conditions: Alzheimer Disease. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, New Zealand, Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug LY3439539
    Administered IV

Primary outcome measures

  • Change from Baseline in Cerebrospinal Fluid (CSF) Neurofilament Light Chain (NfL) [Time frame: Baseline through end of the Follow-up Period (Week 24)]
Secondary outcome measures (4)
  • Change from Baseline in Phospho-Tau (pTau) [Time frame: Baseline through end of the Follow-up Period (Week 24)]
  • Change from Baseline in Plasma NfL [Time frame: Baseline through end of the Follow-up Period (Week 24)]
  • Pharmacokinetics (PK) Maximum LY3439539 Serum Concentration (Cmax) [Time frame: Baseline through end of the Follow-up Period (Week 24)]
  • PK: Minimum LY3439539 Serum Concentration (Cmin) [Time frame: Time Frame: Baseline through end of Follow up Period (Week 24)]

Eligibility criteria

Inclusion criteria

  • 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
  • Are women not of childbearing potential and men willing to practice effective contraception throughout the study.
  • Have adequate premorbid literacy, vision, and hearing throughout the study duration and able to complete study procedures.
  • Have at least 1, and up to 2, study partners who are in frequent contact with the participant (defined as at least 10 hours per week).

Exclusion criteria

  • 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
  • Severe or ongoing allergy or hypersensitivity reactions
  • Hypersensitivity to immunizations or immunoglobulins
  • Two or more clinically significant or severe drug allergies,
  • Intolerance to topical corticosteroids or severe posttreatment hypersensitivity reactions
  • Have current serious or unstable illnesses, including hepatic, renal, gastroenterological, respiratory, cardiovascular, neurologic (other than AD), psychiatric, endocrinologic, immunologic, hematologic disease, or other conditions
  • Require treatment with another monoclonal antibody or have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
  • Have criteria that would preclude a lumbar puncture (LP).
  • Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Have a current exposure to amyloid-targeting therapies (ATTs). Prior exposure to ATTs greater than 1 year from the last dose may be permitted at the discretion of the investigator and in consultation with the sponsor.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Australia · 5 centers
  • Flinders Medical Centre — Adelaide
  • Austin Health - Heidelberg Repatriation Hospital — Ivanhoe
  • Southern Neurology — Kogarah
  • Macquarie University Hospital — Macquarie University
  • The Alfred — Melbourne
United States · 1 center
  • Irvine Clinical Research — Irvine
New Zealand · 1 center
  • Christchurch Neurology Trials — Christchurch
Singapore · 1 center
  • Lilly Centre for Clinical Pharmacology — Singapore

Identifiers

NCT: NCT07598370 · 18818 · I9M-MC-ONAA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗