Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Washington University School of Medicine
Study ID
NCT01760005
Phase
PHASE2/PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Gantenerumab — DRUG
    Subcutaneously every 4 weeks at escalating doses
  • Solanezumab — DRUG
    Intravenous infusion every 4 weeks at escalating doses
  • Matching Placebo (Gantenerumab) — DRUG
    Subcutaneous injection of placebo every 4 weeks
  • Matching Placebo (Solanezumab) — DRUG
    Intravenous infusion of placebo every 4 weeks
  • Gantenerumab — DRUG
    Open-label administered Subcutaneously every 4 weeks at escalating doses
  • E2814 — DRUG
    Administered intravenously in a blinded fashion
  • Lecanemab — DRUG
    Administered intravenously
  • Matching Placebo (E2814) — DRUG
    Placebo administered intravenously in a blinded fashion.

Study Details

The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers.

Key Dates

Start date
Dec 31, 2012
Status verified
Feb 2026
Primary completion
Apr 30, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
490 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Gantenerumab
    This arm completed and is closed.
  • Experimental: Solanezumab
    This arm completed and is closed.
  • Placebo Comparator: Matching placebo (Gantenerumab)
    This arm completed and is closed.
  • Placebo Comparator: Matching Placebo (Solanezumab)
    This arm completed and is closed.
  • No Intervention: Cognitive Run-in
    This arm is completed and closed.
  • Active Comparator: Gantenerumab Open Label Extension
    Subcutaneously every 4 weeks at escalating doses. This arm is completed and closed.
  • Experimental: E2814 plus lecanemab
    Symptomatic Population (Cohort 1) At Week 0, participants will receive open-label lecanemab administered intravenously for the full treatment period. At Week 24, participants randomized to E2814 will receive intravenously in a blinded fashion for the remainder of their treatment period. Asymptomatic Population (Cohort 2) At Week 0, participants randomized to E2814 will receive intravenously in a blinded fashion for the full treatment period. At Week 52, all participants will initiate open-label lecanemab administered intravenously for the remainder of their treatment period.
  • Experimental: Matching placebo (E2814) plus lecanemab
    Symptomatic Population (Cohort 1) At Week 0, participants will receive open-label lecanemab administered intravenously for the full treatment period. At Week 24, participants randomized to E2814 placebo will receive placebo intravenously in a blinded fashion for the remainder of their treatment period. Asymptomatic Population (Cohort 2) At Week 0, participants randomized to E2814 placebo will receive placebo intravenously in a blinded fashion for the full treatment period. At Week 52, all participants will initiate open-label lecanemab administered intravenously for the remainder of their treatment period.

Primary Outcome Measure

Assess cognitive efficacy in individuals with mutations causing dominantly inherited AD as measured by the change from baseline in the DIAN-Multivariate Cognitive Endpoint (DIAN-MCE) [ Time Frame: Baseline and Weeks 52, 104, 156, and 208 ]

Locations (12)

FacilityCityStateZIPSite coordinators
University of Alabama in BirminghamBirminghamAlabama35294-
University of California San Diego Medical CenterLa JollaCalifornia92037-
USC Keck School of MedicineLos AngelesCalifornia90033-
Yale University School of MedicineNew HavenConnecticut06510-
Emory UniversityAtlantaGeorgia30329-
Advocate Lutheran General HospitalPark RidgeIllinois60068-
Indiana University School of MedicineIndianapolisIndiana46202-
Washington University in St. LouisSt LouisMissouri63110-
University of PittsburghPittsburghPennsylvania15213-
Butler HospitalProvidenceRhode Island02096-
Kerwin Medical CenterDallasTexas75231-
University of WashingtonSeattleWashington98195-

Find similar trials in Birmingham, AL

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
University of Alabama in Birmingham· Birmingham, ALUniversity of California San Diego Medical Center· La Jolla, CAUSC Keck School of Medicine· Los Angeles, CAYale University School of Medicine· New Haven, CTEmory University· Atlanta, GAAdvocate Lutheran General Hospital· Park Ridge, IL

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