A Study of Potential Disease Modifying Treatments 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
NCT05552157
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

The purpose is to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an Alzheimer's disease (AD)-causing mutation. Stage 1 will determine if treatment with the study drug prevents or slows the rate of amyloid beta (Aβ) pathological disease accumulation demonstrated by Aβ positron emission tomography (PET) imaging. Stage 2 will evaluate the effect of early Aβ plaque reduction/prevention on disease progression by assessing downstream non-Aβ biomarkers of AD (e.g., CSF total tau, p-tau, NfL) compared to an external control group from the DIAN-OBS natural history study and the DIAN-TU-001 placebo-treated participants.

Key Dates

Start date
Nov 22, 2024
Status verified
Feb 2026
Primary completion
Mar 30, 2034
Completion
Aug 30, 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: Evaluate the ability of study drug to prevent or slow the rate of Aβ accumulation compared with placebo in participants with mutations that cause DIAD [ Time Frame: Baseline and Week 208 ]

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 (PRINCIPAL_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania15213
Sarah Berman (PRINCIPAL_INVESTIGATOR)
Butler HospitalProvidenceRhode Island02096
Edward Denmead Huey (PRINCIPAL_INVESTIGATOR)
Kerwin Research and Memory CenterDallasTexas75231
Alka Khera (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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