Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

17 maj 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

200

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Zhejiang
      • Wenzhou, Zhejiang, Kina
        • Rekrytering
        • First Affiliated Hospital of Wenzhou Medical University
        • Kontakt:
          • First Affiliated Hospital of Wenzhou Medical University
          • Telefonnummer: +8613858868961
          • E-post: wyyy@wzhospital.cn

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Lecanemab treatment group
Läkemedel: 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
Läkemedel: Konventionell anti-demensbehandlingsgrupp
Konventionell anti-demensbehandling: Alzheimers sjukdom i tidigt stadium (AD) tar rutinmässigt kolinesterasinhibitorer såsom donepezil för behandling.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Aβ-PET centiloid values
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change of retinal and cerbral imaging
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: baseline, 6 month, 12 month, 18 month
Blood oxygenation level dependent (BOLD) imaging
baseline, 6 month, 12 month, 18 month

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2026

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

31 december 2028

Studieregistreringsdatum

Först inskickad

17 maj 2026

Först inskickad som uppfyllde QC-kriterierna

17 maj 2026

Första postat (Faktisk)

22 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • KY2025-355

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera