Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease
Public ClinicalTrials.gov record NCT05026177. 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 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 76-week Study Evaluating the Safety and Efficacy of Two Doses of Simufilam in Subjects With Mild-to-Moderate Alzheimer's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A 76-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild-to-moderate Alzheimer's disease (AD) for 76 weeks. Approximately 1083 participants will be randomized (1:1:1) to receive either placebo, 50 mg tablets of simufilam, or 100 mg tablets of simufilam, twice daily, for 76 weeks. Clinic visits will occur 4 weeks after the baseline visit, and then every 12 weeks until the end of the study. The safety of simufilam, and its efficacy in enhancing cognition and slowing cognitive and functional decline will be evaluated.
Study identification
- NCT ID
- NCT05026177
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,125 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years to 87 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
- Nov 18, 2021 (Actual)
- Primary completion
- Dec 30, 2024 (Actual)
- Completion
- Dec 30, 2024 (Actual)
- Last update posted
- Sep 22, 2025
2021 – 2024
United States locations
- U.S. sites
- 65
- U.S. states
- 19
- U.S. cities
- 60
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Alzheimer's Institute | Phoenix | Arizona | 85006 | — |
| Arizona Neuroscience Research, LLC | Phoenix | Arizona | 85032 | — |
| Clinical Endpoints | Scottsdale | Arizona | 85258 | — |
| Banner Sun Health Research Institute | Sun City | Arizona | 85351 | — |
| Banner Alzheimer's Institute - Tucson | Tucson | Arizona | 85718 | — |
| North County Neurology Associates | Carlsbad | California | 92011 | — |
| Neuro-Pain Medical Center | Fresno | California | 93710 | — |
| Neurology Center of North Orange County | Fullerton | California | 92835 | — |
| Healthy Brain Clinic | Long Beach | California | 90804 | — |
| California Research Insitute | Los Angeles | California | 90027 | — |
| Shankle Clinic and Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | — |
| Pacific Research Network, LLC | San Diego | California | 92103 | — |
| Nuvance Health Medical Practice CT, Inc. - Associated Neurologists, PC | Danbury | Connecticut | 06810 | — |
| Ki Health Partners, LLC | Stamford | Connecticut | 06905 | — |
| JEM Research Institute | Atlantis | Florida | 33462 | — |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | — |
| Clinical Research of Brandon, LLC | Brandon | Florida | 33511 | — |
| Quantum Laboratories | Deerfield Beach | Florida | 33442 | — |
| Brain Matters Research Inc | Delray Beach | Florida | 33445 | — |
| Indago Research and Health Center, Inc. | Hialeah | Florida | 33012 | — |
| Alphab Global Research | Jupiter | Florida | 33458 | — |
| K2 Medical Research | Maitland | Florida | 32751 | — |
| Mind Institute at Miami Jewish Health | Miami | Florida | 33137 | — |
| Brainstorm Research | Miami | Florida | 33176 | — |
| Health Synergy Clinical Research | Okeechobee | Florida | 34972 | — |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Orlando | Florida | 32801 | — |
| Intercoastal Medical Group - Sarasota | Sarasota | Florida | 34239 | — |
| Alzheimer's Research & Treatment Center | Stuart | Florida | 34997 | — |
| Brain Matters Research Inc | Stuart | Florida | 34997 | — |
| USF Health - Byrd Alzheimer's Center and Research Institute | Tampa | Florida | 33613 | — |
| Alzheimer's Research & Treatment Center | Wellington | Florida | 33414 | — |
| Conquest Research | Winter Park | Florida | 32789 | — |
| Columbus Memory Center, PC | Columbus | Georgia | 31909 | — |
| Accel Research Sites - NeuroStudies | Decatur | Georgia | 30030 | — |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | — |
| Advocate Aurora Health | Park Ridge | Illinois | 60068 | — |
| University of Kentucky Sanders-Brown Center on Aging | Lexington | Kentucky | 40504 | — |
| Neurology Center of New England | Foxborough | Massachusetts | 02035 | — |
| ActivMed Practices & Research, LLC | Methuen | Massachusetts | 01844 | — |
| Boston Center for Memory | Newton | Massachusetts | 02459 | — |
| Office of Donald S. Marks, M.D., P.C. | Plymouth | Massachusetts | 02360 | — |
| MedVadis Research | Waltham | Massachusetts | 02451 | — |
| Patient First MD | Middletown | New Jersey | 07748 | — |
| Global Medical Institutes, LLC | Princeton | New Jersey | 08540 | — |
| The Cognitive and Research Center of New Jersey (CRCNJ) | Springfield | New Jersey | 07081 | — |
| Advanced Memory Research Institute of NJ | Toms River | New Jersey | 08755 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| Neurological Associates of Albany | Albany | New York | 12208 | — |
| Integrative Clinical Trials | Brooklyn | New York | 11229 | — |
| SPRI Clinical Trials Brooklyn | Brooklyn | New York | 11235 | — |
| Velocity Clinical Research, Formerly Clarity Clinical Research | East Syracuse | New York | 13057 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | — |
| Accellacare Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Neurology Diagnostics | Dayton | Ohio | 45459 | — |
| Neuro-Behavioral Clinical Research (NBCR) | North Canton | Ohio | 44720 | — |
| Center for Cognitive Health - Portland | Portland | Oregon | 97225 | — |
| The Clinical Trial Center | Jenkintown | Pennsylvania | 19046 | — |
| Keystone Clinical Studies, LLC | Plymouth Meeting | Pennsylvania | 19462 | — |
| KCA Neurology, PLLC | Franklin | Tennessee | 37067 | — |
| Neurology Consultants of Dallas, PA | Dallas | Texas | 75243 | — |
| Cedar Health Research | Irving | Texas | 75062 | — |
| The Memory Clinic - Bennington | Bennington | Vermont | 05201 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 NCT05026177, 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 22, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05026177 live on ClinicalTrials.gov.