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Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs

17. mai 2026 oppdatert av: First Affiliated Hospital of Wenzhou Medical University

Multicenter, Randomized, Controlled Study Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs

This research proposal outlines a multi-center, randomized, trial. Patients diagnosed with early-to-moderate Alzheimer's Disease will be recruited. Participants will be randomly assigned to receive either Lecanemab. The study will run over a period of 24 months, with evaluations conducted at baseline, 6 months, and 12 months, 18 months and 24 months. Data from multiple omics layers will be integrated to assess both the efficacy and safety of the treatment.

The primary aim of this study is to assess the efficacy and safety of Lecanemab in patients with Alzheimer's Disease, leveraging multi-omics approaches. Specifically, the study will integrate data from OCT/OCTA imaging of the eye and MRI imaging of the brain, as well as cognitive measures such as ADAS-Cog, MoCA and CDR scores. Furthermore, the presence of ARIA-a significant safety concern in amyloid-targeting therapies-will be closely monitored. The study seeks to provide a more robust understanding of Lecanemab's impact on disease progression, cognition, and potential adverse effects, contributing to a more informed clinical application of this treatment in Alzheimer's care.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

200

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Zhejiang
      • Wenzhou, Zhejiang, Kina
        • Rekruttering
        • First Affiliated Hospital of Wenzhou Medical University
        • Ta kontakt med:
          • First Affiliated Hospital of Wenzhou Medical University
          • Telefonnummer: +8613858868961
          • E-post: wyyy@wzhospital.cn

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Age: 50 to 90 years old.
  • No gender restrictions.
  • Patients with MCI and mild AD.
  • The MMSE score is ≥20, and the overall CDR score is 0.5 or 1 point.
  • Positive Amyloid protein confirmed by amyloid-PET or CSF.
  • There is a reliable caregiver accompanying the patient during the research visit and supervising the use of the study drug during the trial.
  • Agree to participate in the research and sign the informed consent form.

Exclusion Criteria:

  • Patients with cognitive impairment caused by reasons other than AD.
  • There was a history of transient ischemic attack (TIA), stroke, cerebral hemorrhage or epileptic seizure within 12 months prior to screening.
  • A Hamilton Depression Scale score of more than 17 at the time of screening, or any suicidal behavior within 6 months before screening, during screening, or at baseline visits, as well as other psychiatric diagnoses or symptoms (such as hallucinations, anxiety disorders, or delusions) that interfere with the research process of the subjects.
  • Patients with hemorrhagic diseases or those receiving anticoagulant therapy, as well as any patients with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine and cardiovascular system diseases that affect this study.
  • There is a hypersensitivity reaction to lecanemumab or any other component in the injection solution or any monoclonal antibody treatment.
  • There are contraindications for MRI scans, including the installation of cardiac pacemakers/defibrillators and ferromagnetic metal implants (except for cranial and cardiac devices approved for safe use in MRI scans).
  • There is a known or suspected history of drug or alcohol abuse or dependence within two years prior to screening.
  • Subjects who participated in clinical studies involving any therapeutic monoclonal antibodies or novel compounds for the treatment of AD within 6 months prior to screening, unless it can be demonstrated that the subjects were in the placebo treatment group.
  • Surgical operations under general anesthesia are planned to be performed during the research period.
  • Women who have positive pregnancy test results, are breastfeeding or pregnant at the time of screening or baseline.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Lecanemab treatment group
Legemiddel: Lecanemab 10 mg/kg
Lecanemab Injection Concentrate Solution (active ingredient at 100 mg/mL) is provided as a sterile aqueous solution containing 100 mg/mL of Lecanemab, 50 mmol/L citric acid, 350 mmol/L arginine/arginine hydrochloride, and 0.05% (w/v) polysorbate 80, with a pH of 5.0, and each vial is capable of being drawn into a volume of 5 mL. Lecanemab is to be administered via intravenous infusion over 60 minutes in saline solution. Lecanemab must be administered using an infusion system that includes a terminal 0.22 μM inline filter. The dosage of Lecanemab is 10 mg/kg.
Aktiv komparator: Conventional anti-dementia treatment
Legemiddel: Konvensjonell anti-demens behandlingsgruppe
Konvensjonell anti-demensbehandling: Alzheimers sykdom (AD) -pasienter i tidlig stadium tar rutinemessig kolinesterasehemmere som donepezil for behandling.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Aβ-PET centiloid values
Tidsramme: baseline, 12 month, 18 months
Change in Lecanemab versus Conventional Anti-Dementia Treatment Based on Aβ-PET Centiloid Scores in 18 months
baseline, 12 month, 18 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change of retinal and cerbral imaging
Tidsramme: baseline, 6 month, 12 month
Retinal and cerbral imaging Difference Between Lecanemab and Conventional Anti-Dementia Treatment Groups
baseline, 6 month, 12 month
Change of MoCA score
Tidsramme: baseline, 6 month, 12 month, 18 months
Assess the difference in MoCA Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups
baseline, 6 month, 12 month, 18 months
Change of MMSE score
Tidsramme: baseline, 6 month, 12 month, 18 months
Assess the difference in MMSE Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups
baseline, 6 month, 12 month, 18 months
Change of CDR score
Tidsramme: baseline, 6 month, 12 month, 18 months
Assess the difference in CDR Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups
baseline, 6 month, 12 month, 18 months
Change of structural MRI
Tidsramme: baseline, 6 month, 12 month, 18 month
3D T1-weighted, 3D T2-weighted and Diffusion Tensor Imaging (DTI)
baseline, 6 month, 12 month, 18 month
Change of functional MRI
Tidsramme: baseline, 6 month, 12 month, 18 month
Blood oxygenation level dependent (BOLD) imaging
baseline, 6 month, 12 month, 18 month

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2026

Primær fullføring (Antatt)

31. desember 2027

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

17. mai 2026

Først innsendt som oppfylte QC-kriteriene

17. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KY2025-355

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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