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
Public ClinicalTrials.gov record NCT05552157. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled, Two-Stage Adaptive Design, Platform Trial of Investigational Treatments for Primary Prevention of Disease Progression in Dominantly Inherited Alzheimer's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05552157
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 280 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 21, 2024
- Primary completion
- Mar 29, 2034
- Completion
- Aug 29, 2034
- Last update posted
- Jul 26, 2026
2024 – 2034
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama in Birmingham | Birmingham | Alabama | 35294 | Recruiting |
| University of California San Diego Medical Center | La Jolla | California | 92037 | Recruiting |
| University of Southern Califonria | Los Angeles | California | 90089 | Not yet recruiting |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | Recruiting |
| Emory University | Atlanta | Georgia | 30329 | Recruiting |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | Recruiting |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | Recruiting |
| Washington University in St. Louis | St Louis | Missouri | 63110 | Recruiting |
| New York University Medical Center | New York | New York | 10016 | Recruiting |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | Recruiting |
| Butler Hospital | Providence | Rhode Island | 02096 | Recruiting |
| Kerwin Research and Memory Center | Dallas | Texas | 75231 | Recruiting |
| University of Washington | Seattle | Washington | 98195 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05552157, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 26, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05552157 live on ClinicalTrials.gov.