A Study of LY3439539 in Participants With Alzheimer's Disease
14. maj 2026 opdateret af: Eli Lilly and Company
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
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
30
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Telefonnummer: 1-317-615-4559
- E-mail: LillyTrials@Lilly.com
Undersøgelse Kontakt Backup
- Navn: Physicians interested in becoming principal investigators please contact
- E-mail: clinical_inquiry_hub@lilly.com
Studiesteder
-
-
-
Adelaide, Australien, 5042
- Flinders Medical Centre
-
Kontakt:
- Telefonnummer: +61 482 130 622
-
Ledende efterforsker:
- Lauren Priest
-
Birtinya, Australien, 4575
- University of the Sunshine Coast Clinical Trial Centre
-
Ledende efterforsker:
- Peter De Wet
-
Kontakt:
- Telefonnummer: +617 54563872
-
Ivanhoe, Australien, 3079
- Austin Health - Heidelberg Repatriation Hospital
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Ledende efterforsker:
- Paul Yates
-
Kontakt:
- Telefonnummer: +613 9496 2388
-
Kogarah, Australien, 2217
- Southern Neurology
-
Ledende efterforsker:
- Raymond Schwartz
-
Kontakt:
- Telefonnummer: +612 8566 1500
-
Macquarie University, Australien, 2109
- Macquarie University Hospital
-
Kontakt:
- Telefonnummer: 0298122956
-
Ledende efterforsker:
- James Burrell
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Melbourne, Australien, 3004
- The Alfred
-
Ledende efterforsker:
- David Darby
-
Kontakt:
- Telefonnummer: 0437 498 365
-
-
-
-
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Singapore, Singapore, 138623
- Lilly Centre for Clinical Pharmacology
-
Kontakt:
- Telefonnummer: +65 6413 9811
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Ledende efterforsker:
- Jeffer Hann Wei Pang
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: LY3439539
LY3439539 administered intravenously (IV)
|
Administered IV
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from Baseline in Cerebrospinal Fluid (CSF) Neurofilament Light Chain (NfL)
Tidsramme: Baseline through end of the Follow-up Period (Week 24)
|
Baseline through end of the Follow-up Period (Week 24)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from Baseline in Phospho-Tau (pTau)
Tidsramme: Baseline through end of the Follow-up Period (Week 24)
|
Baseline through end of the Follow-up Period (Week 24)
|
|
Change from Baseline in Plasma NfL
Tidsramme: Baseline through end of the Follow-up Period (Week 24)
|
Baseline through end of the Follow-up Period (Week 24)
|
|
Pharmacokinetics (PK) Maximum LY3439539 Serum Concentration (Cmax)
Tidsramme: Baseline through end of the Follow-up Period (Week 24)
|
Baseline through end of the Follow-up Period (Week 24)
|
|
PK: Minimum LY3439539 Serum Concentration (Cmin)
Tidsramme: Time Frame: Baseline through end of Follow up Period (Week 24)
|
Time Frame: Baseline through end of Follow up Period (Week 24)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: 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), Eli Lilly and Company
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. maj 2026
Primær færdiggørelse (Anslået)
1. maj 2027
Studieafslutning (Anslået)
1. maj 2027
Datoer for studieregistrering
Først indsendt
14. maj 2026
Først indsendt, der opfyldte QC-kriterier
14. maj 2026
Først opslået (Faktiske)
20. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 18818
- I9M-MC-ONAA (Anden identifikator: Eli Lilly and Company)
Plan for individuelle deltagerdata (IPD)
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INGEN
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