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NCT05552157 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Dementia and Alzheimers Disease, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 280
- Enrollment target
- 20
- Study locations
NCT05552157: Recruiting Phase 2 study of Dementia and Alzheimers Disease, sponsored by Washington University School of Medicine.
NCT05552157 is a Phase 2 study of Dementia and Alzheimers Disease that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 280 participants, below the 7,722-participant average among 199 other Dementia trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05552157, a Phase 2 study of Dementia and Alzheimers Disease, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 280 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Defined in each drug-specific appendix; will be an assessment of biomarkers of early-stage disease (e.g., amyloid PET, soluble amyloid, soluble phospho-tau) compared with baseline in each treatment group
Conditions Studied
Interventions
- DRUG Matching Placebo (Remternetug)
- DRUG Remternetug (SC)
Study Locations (20)
Other
- Instituto de Investigaciones Neurologicas Raul Carrea, FLENI - Ciudad Autonoma de Buenos Aire
- CHU de Quebec - Hôpital de l' Enfant Jésus - Québec
- Grupo de Neurociencias Sede de la Universidad de Antioquia - Medellín
Alabama
- University of Alabama in Birmingham - Birmingham
California
- University of California San Diego Medical Center - La Jolla
Connecticut
- Yale University School of Medicine - New Haven
Georgia
- Emory University - Atlanta
Illinois
- Advocate Lutheran General Hospital - Park Ridge
Indiana
- Indiana University School of Medicine - Indianapolis
Missouri
- Washington University in St. Louis - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2024-11-22 |
| Est. Completion | 2034-08-30 |
| Phase | Phase 2 |
What NCT05552157 shows while recruiting
NCT05552157 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, below the 7,722-participant average among 199 other Dementia trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Dementia appearing as the primary indexed condition, and to 2 interventions - of which Matching Placebo (Remternetug) is the first listed.
NCT05552157 names 20 study sites across 18 states, led by Other, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT05552157 about?
NCT05552157 is a clinical study titled "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". 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) patholo...
What is the current status of trial NCT05552157?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 280 participants. The study started on 2024-11-22. Estimated completion is 2034-08-30.
What conditions does trial NCT05552157 study?
This clinical trial studies the following conditions: Dementia, Alzheimers Disease, Alzheimers Disease, Familial.
What interventions are being tested in trial NCT05552157?
The interventions under investigation include: Matching Placebo (Remternetug) (DRUG), Remternetug (SC) (DRUG).
Who is sponsoring clinical trial NCT05552157?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05552157 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dementia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05552157's enrollment target sits among peer trials
280 75th of 199 higher than 124 of 199 other Dementia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dementia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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