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NCT03533257 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Safety and Biological Activity of AMX0035 for the Treatment of Alzheimer's Disease
A Phase 2 study of Alzheimer Disease, sponsored by Amylyx Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
- 11
- Study locations
NCT03533257: Completed Phase 2 study of Alzheimer Disease, sponsored by Amylyx Pharmaceuticals.
NCT03533257 is a Phase 2 study of Alzheimer Disease that has completed, run by Amylyx Pharmaceuticals. The registered enrollment target is 95 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (97% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03533257, a Phase 2 study of Alzheimer Disease, has completed, sponsored by Amylyx Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
- 11
- Study locations
Study Summary
The study is a 24-week, randomized, double-blind, multi-site, placebo-controlled study in participants with mild cognitive impairment (MCI) or early dementia due to Alzheimer's disease (AD).
Primary Outcome
Comparison between the AMX0035 Group and Placebo of the number of participants with TEAEs
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AMX0035
Study Locations (11)
Florida
- Clinical Neuroscience Solutions, Inc. - Jacksonville - Jacksonville
- Clinical Neuroscience Solutions, Inc. - Orlando - Orlando
- International Medical Investigational Centers (IMIC) - Palmetto Bay
New York
- Mount Sinai Alzheimer's Disease Research Center - New York
- Columbia University - New York
Illinois
- Rush University Medical Center - Chicago
Kansas
- University of Kansas Clinical Research Center - Fairway
Massachusetts
- Massachusetts General Hospital - Boston
New Jersey
- Rowan University School of Osteopathic Medicine - Stratford
Pennsylvania
- Hospital of the University of Pennsylvania, Penn Memory Center - Philadelphia
Tennessee
- Genesis NeuroScience Clinic - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2018-09-14 |
| Est. Completion | 2020-11-06 |
| Phase | Phase 2 |
What the finished NCT03533257 record still lists
NCT03533257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03533257 lists 11 locations in 8 states (Florida, New York, Illinois).
Frequently Asked Questions
What is clinical trial NCT03533257 about?
NCT03533257 is a clinical study titled "Study to Assess the Safety and Biological Activity of AMX0035 for the Treatment of Alzheimer's Disease". The study is a 24-week, randomized, double-blind, multi-site, placebo-controlled study in participants with mild cognitive impairment (MCI) or early dementia due to Alzheimer's disease (AD).
What is the current status of trial NCT03533257?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2018-09-14. Estimated completion is 2020-11-06.
What conditions does trial NCT03533257 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT03533257?
The interventions under investigation include: Placebo (DRUG), AMX0035 (DRUG).
Who is sponsoring clinical trial NCT03533257?
This trial is sponsored by Amylyx Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03533257 being conducted?
This trial has 11 study locations across Florida, Illinois, Kansas, Massachusetts, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
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 NCT03533257's enrollment target sits among peer trials
95 157th of 306 higher than 149 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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