A Study of a Potential Disease Modifying Treatment in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Washington University School of Medicine
Study ID
NCT06647498
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Remternetug — DRUG
    Administered subcutaneously every 12 weeks
  • Matching Placebo (Remternetug) — DRUG
    Administered as subcutaneous injection of placebo every 12 weeks

Study Details

The purpose of this research study is to test the study drug, referred to as remternetug, to determine its effectiveness for the study treatment of asymptomatic (at risk) Alzheimer disease in individuals with AD-causing mutations. This study will also investigate the effects of remternetug on biomarkers (measures of the disease including brain scans, blood and spinal fluid tests), examine safety data to identify any potential benefits or risks, and examine how well participants can tolerate remternetug. Stage 1 will determine if treatment with the study drug prevents or reverses amyloid beta (Aβ) accumulation compared with placebo in participants with dominantly inherited Alzheimer's disease (DIAD). Stage 2 will evaluate the effect of early anti-amyloid treatment on downstream biomarkers of AD in treated participants compared to external control groups.

Key Dates

Start date
Nov 22, 2024
Status verified
Feb 2026
Primary completion
Mar 31, 2034
Completion
Aug 31, 2034

Study Design

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

Arms

  • Experimental: Stage 1: Remternetug
    Active Remternetug- blinded
  • Placebo Comparator: Stage 1: Matching placebo (Remternetug)
    Matching placebo
  • Active Comparator: Stage 2: Remternetug Open Label
    Open label will start after last dose of Stage 1

Primary Outcome Measure

Stage 1: Change in amyloid load as measured by centiloid (CL) [11C]PiB-PET as biomarker endpoint for DIAN-TU-002 remternetug arm [ Time Frame: Baseline and Week 192 ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
University of Alabama in BirminghamBirminghamAlabama35294
Erik Roberson (PRINCIPAL_INVESTIGATOR)
University of California San Diego Medical CenterLa JollaCalifornia92037
Doug Galasko (PRINCIPAL_INVESTIGATOR)
Yale University School of MedicineNew HavenConnecticut06510
Christopher Van Dyck (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30329
James Lah (PRINCIPAL_INVESTIGATOR)
Advocate Lutheran General HospitalPark RidgeIllinois60068
Darren Gitelman (PRINCIPAL_INVESTIGATOR)
Indiana University School of MedicineIndianapolisIndiana46202
Jared Brosch (PRINCIPAL_INVESTIGATOR)
Washington University in St. LouisSt LouisMissouri63110
Barbara Snider (PRINCIPAL_INVESTIGATOR)
New York University Medical CenterNew YorkNew York10016
Thomas Wisniewski, MD (PRINCIPAL_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania15213
Sarah Berman (PRINCIPAL_INVESTIGATOR)
Butler HospitalProvidenceRhode Island02096
Edward Denmead Huey (PRINCIPAL_INVESTIGATOR)
Kerwin Research and Memory CenterDallasTexas75231
Alka Khera, MD (PRINCIPAL_INVESTIGATOR)
University of WashingtonSeattleWashington98195
Suman Jayadev (PRINCIPAL_INVESTIGATOR)

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, CAYale University School of Medicine· New Haven, CTEmory University· Atlanta, GAAdvocate Lutheran General Hospital· Park Ridge, ILIndiana University School of Medicine· Indianapolis, IN

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