Safety and Efficacy of TRx0237 in Subjects With Alzheimer's Disease Followed by Open-Label Treatment
Public ClinicalTrials.gov record NCT03446001. 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
Randomized, Double-Blind, Placebo-Controlled, Three-Arm, 12-Month, Safety and Efficacy Study of TRx0237 Monotherapy in Subjects With Alzheimer's Disease Followed by a 12-Month Open-Label Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the safety and efficacy of TRx0237 16 mg/day and 8 mg/day in the treatment of subjects with Alzheimer's Disease compared to placebo. In addition, an open-label, delayed-start phase is included to demonstrate a disease-modifying effect of TRx0237.
Study identification
- NCT ID
- NCT03446001
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 598 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 90 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
- Dec 1, 2017 (Actual)
- Primary completion
- Mar 31, 2022 (Actual)
- Completion
- Apr 4, 2023 (Actual)
- Last update posted
- Sep 4, 2025
2017 – 2023
United States locations
- U.S. sites
- 60
- U.S. states
- 15
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Xenoscience | Phoenix | Arizona | 85004 | — |
| Arizona Research Center | Phoenix | Arizona | 85053 | — |
| Imaging Endpoints Research | Scottsdale | Arizona | 85258 | — |
| Atria Clinical Research | Little Rock | Arkansas | 72209 | — |
| ATP Clinical Research, Inc. | Costa Mesa | California | 92626 | — |
| HB Clinical Trials Inc. | Fountain Valley | California | 92708 | — |
| Fullerton Neurology and Headache Center | Fullerton | California | 92835 | — |
| Senior Clinical Trials, Inc. | Laguna Hills | California | 92653 | — |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | — |
| Excell Research, Inc. | Oceanside | California | 92056 | — |
| Sharp Mesa Vista Hospital | San Diego | California | 92123 | — |
| Syrentis Clinical Research | Santa Ana | California | 92705 | — |
| California Neuroscience Medical Group | Sherman Oaks | California | 91403 | — |
| Visionary Investigators Network | Aventura | Florida | 33180 | — |
| Finlay Medical Research | Greenacres City | Florida | 33467 | — |
| MD Clinical | Hallandale | Florida | 33009 | — |
| Indago Research & Health Center, Inc. | Hialeah | Florida | 33012 | — |
| Merrit Island Medical Research | Merritt Island | Florida | 32952 | — |
| Health Care Family Rehab and Research | Miami | Florida | 33015 | — |
| Optimus Clinical Research | Miami | Florida | 33125 | — |
| Biomed Research Institute, Inc | Miami | Florida | 33126 | — |
| Finlay Medical Research | Miami | Florida | 33126 | — |
| CCM Clinical Research Group | Miami | Florida | 33133 | — |
| Advance Medical Research Center | Miami | Florida | 33135 | — |
| Vitae Research Center, LLC | Miami | Florida | 33135 | — |
| L&C Professional Medical Research Institute | Miami | Florida | 33144 | — |
| Allied Biomedical Research Institute | Miami | Florida | 33155 | — |
| Future Care Solution, LLC | Miami | Florida | 33165 | — |
| Florida International Research Center | Miami | Florida | 33173 | — |
| Miami Dade Medical Research Institute, LLC | Miami | Florida | 33176 | — |
| Visionary Investigators Network | Miami | Florida | 33176 | — |
| Sensible Healthcare | Ocoee | Florida | 34761 | — |
| Bioclinica Research | Orlando | Florida | 32806 | — |
| IMIC Inc | Palmetto Bay | Florida | 33157 | — |
| Emerald Coast Center for Neurological Disorders | Pensacola | Florida | 32504 | — |
| Progressive Medical Research | Port Orange | Florida | 32127 | — |
| The Roskamp Institute, Inc. | Sarasota | Florida | 34243 | — |
| Stedman Clinical Trials | Tampa | Florida | 33613 | — |
| Alzheimer's Research and Treatment Center | Wellington | Florida | 33414 | — |
| NeuroStudies.net, LLC | Decatur | Georgia | 30033 | — |
| Georgia Neurology and Sleep Medicine Associates | Suwanee | Georgia | 30024 | — |
| Josephson Wallack Munshower Neurology P.C. | Indianapolis | Indiana | 46256 | — |
| Advanced Memory Research of NJ PC | Toms River | New Jersey | 08755 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| UBMD Neurology | Buffalo | New York | 14203 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | — |
| Alzheimer's Memory Center | Charlotte | North Carolina | 28270 | — |
| Neuroscience Research Center, LLC | Canton | Ohio | 44718 | — |
| Valley Medical Research | Centerville | Ohio | 45459 | — |
| The Lindner Research Center | Cincinnati | Ohio | 45219 | — |
| Neurology Diagnostics Inc. | Dayton | Ohio | 45459 | — |
| Neuro-Behavioral Clinical Research, Inc. | North Canton | Ohio | 44321 | — |
| IPS Research Company | Oklahoma City | Oklahoma | 73106 | — |
| Tulsa Clinical Research LLC | Tulsa | Oklahoma | 74136 | — |
| Neural Net Research | Portland | Oregon | 97225 | — |
| CBRI - Roper Hospital | Charleston | South Carolina | 29414 | — |
| Coastal Neurology | Port Royal | South Carolina | 29935 | — |
| Re:Cognition Health | Fairfax | Virginia | 22031 | — |
| Kingfisher Cooperative, LLC | Spokane | Washington | 99202 | — |
| Universal Research Group, LLC | Tacoma | Washington | 98405 | — |
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 43 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03446001, 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 Sep 4, 2025 · Synced Nov 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03446001 live on ClinicalTrials.gov.