A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Eisai Inc.
Study ID
NCT06602258
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • E2814 — DRUG
    E2814 IV infusion.
  • Lecanemab — DRUG
    Lecanemab SC injection.
  • Placebo — DRUG
    Placebo IV infusion.

Study Details

The primary objective of the study is to determine the dose response of E2814, when concurrently administered with lecanemab, on the change from baseline at 6 months in cerebrospinal fluid (CSF) microtubule-binding region (MTBR)-tau-243 in participants with early Alzheimer's disease (AD).

Key Dates

Start date
Sep 30, 2024
Status verified
Jan 2026
Primary completion
Dec 3, 2026
Completion
Aug 18, 2027

Study Design

Enrollment
105 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: E2814 Dose A + Lecanemab
    Participants will receive E2814 Dose A administered as an intravenous (IV) infusion, every four weeks (Q4W) along with lecanemab administered as a subcutaneous (SC) injection, every week (QW).
  • Experimental: E2814 Dose B + Lecanemab
    Participants will receive E2814 Dose B administered as an IV infusion, Q4W along with lecanemab administered as a SC injection, QW.
  • Experimental: E2814 Dose C + Lecanemab
    Participants will receive E2814 Dose C administered as an IV infusion, Q4W along with lecanemab administered as a SC injection, QW.
  • Experimental: E2814 Dose D + Lecanemab
    Participants will receive E2814 Dose D administered as an IV infusion, Q4W along with lecanemab administered as a SC injection, QW.
  • Experimental: Placebo + Lecanemab
    Participants will receive placebo administered as an IV infusion, Q4W along with lecanemab administered as a SC injection, QW.

Primary Outcome Measure

Change From Baseline in CSF MTBR-tau-243 at 6 Months [ Time Frame: Baseline at 6 months ]

Locations (18)

FacilityCityStateZIPSite coordinators
Banner Sun Health ResearchPhoenixArizona85006-
Yale University School of MedicineNew HavenConnecticut06510-
Bradenton Research CenterBradentonFlorida34205-
K2 Medical ResearchClermontFlorida34711-
Advanced Clinical Research NetworkMiamiFlorida33165-
Renstar Medical ResearchOcalaFlorida34470-
Progressive Medical ResearchPort OrangeFlorida32124-
Alzheimer's Research and Treatment Center-StuartStuartFlorida34997-
Axiom Brain HealthTampaFlorida33609-
Charter ResearchThe VillagesFlorida32162-
Alzheimer's Research and Treatment CenterWellingtonFlorida33467-
Columbus Memory Center, PCColumbusGeorgia31909-
Hattiesburg ClinicHattiesburgMississippi39401-
Washington University School of MedicineSt LouisMissouri63110-
Abington Neurological Associates LTDAbingtonPennsylvania19001-
Neurology Clinic, P.C.CordovaTennessee38018-
Kerwin Memory CenterDallasTexas75231-
National Clinical Research-Richmond, IncRichmondVirginia23294-

Find similar trials in Phoenix, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Banner Sun Health Research· Phoenix, AZYale University School of Medicine· New Haven, CTBradenton Research Center· Bradenton, FLK2 Medical Research· Clermont, FLAdvanced Clinical Research Network· Miami, FLRenstar Medical Research· Ocala, FL

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