Study to Assess the Safety and Biological Activity of AMX0035 for the Treatment of Alzheimer's Disease
Public ClinicalTrials.gov record NCT03533257. 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
Phase II Study to Assess the Safety, Tolerability, and Target Engagement of AMX0035, a Fixed Combination of Sodium Phenylbutyrate and Tauroursodeoxycholic Acid for the Treatment of Alzheimer's Disease
Study identification
- NCT ID
- NCT03533257
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Amylyx Pharmaceuticals Inc.
- Industry
- Enrollment
- 95 participants
Conditions and interventions
Conditions
Interventions
- AMX0035 Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 55 Years to 89 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 13, 2018
- Primary completion
- Oct 21, 2020
- Completion
- Nov 5, 2020
- Last update posted
- Mar 6, 2025
2018 – 2020
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Neuroscience Solutions, Inc. - Jacksonville | Jacksonville | Florida | 32256 | — |
| Clinical Neuroscience Solutions, Inc. - Orlando | Orlando | Florida | 32801 | — |
| International Medical Investigational Centers (IMIC) | Palmetto Bay | Florida | 33157 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Kansas Clinical Research Center | Fairway | Kansas | 66205 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Rowan University School of Osteopathic Medicine | Stratford | New Jersey | 08084 | — |
| Mount Sinai Alzheimer's Disease Research Center | New York | New York | 10029 | — |
| Columbia University | New York | New York | 10032 | — |
| Hospital of the University of Pennsylvania, Penn Memory Center | Philadelphia | Pennsylvania | 19104 | — |
| Genesis NeuroScience Clinic | Knoxville | Tennessee | 37909 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03533257, 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 Mar 6, 2025 · Synced May 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03533257 live on ClinicalTrials.gov.