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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

Study acronym: DIAN-TU
StatusRecruiting
PhasePhase 2/3
Started2024-11-22
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 13 times since 2022-09-22; most recent filed 2026-07-23. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-07-23
Amendment Study Status, Eligibility, Contacts/Locations v13
2026-02-11
Amendment Study Status, Contacts/Locations v12
2025-11-10
Amendment Study Status, Oversight, Study Description, Contacts/Locations v11
2025-07-30
Amendment Study Status, Oversight, Contacts/Locations v10
2025-03-31
Amendment Study Status, Contacts/Locations v9
2024-11-25
Amendment Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v8
2024-10-17
Amendment Study Status, Study Description v7
2024-10-15
Amendment Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, References v6
2024-09-23
Amendment Suspended→Not Yet Recruiting Study Status, Arms and Interventions, Contacts/Locations v5
2024-06-07
Amendment Study Status, Study Description v4
2024-03-04
Amendment Study Status v3
2023-01-10
Amendment Recruiting→Suspended Study Status, Contacts/Locations v2
2022-12-13
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
2022-09-22
Original filing
Trial Details
NCT Number NCT05552157
Lead Sponsor Washington University School of Medicine
Collaborators: Alzheimer's Association, Eli Lilly and Company, National Institute on Aging (NIA)
Conditions Alzheimers Disease, Dementia, Alzheimers Disease, Familial
Enrollment 280 participants
Start Date 2024-11-22
Primary Completion 2034-03-30 (estimated)
Study Completion 2034-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-27