Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease
Public ClinicalTrials.gov record NCT04994483. 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, 52-week Study Evaluating the Safety and Efficacy of Simufilam 100 mg Tablets in Subjects With Mild-to-Moderate Alzheimer's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A 52-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild-to-moderate Alzheimer's disease (AD) for 52 weeks. Approximately 750 participants will be randomized (1:1) to receive either placebo or 100 mg tablets of simufilam, twice daily, for 52 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
- NCT04994483
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 804 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 3, 2021 (Actual)
- Primary completion
- Oct 2, 2024 (Actual)
- Completion
- Oct 2, 2024 (Actual)
- Last update posted
- May 25, 2025
2021 – 2024
United States locations
- U.S. sites
- 74
- U.S. states
- 25
- U.S. cities
- 68
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| MDFirst Research | Chandler | Arizona | 85286 | — |
| CCT Research - Gilbert Neurology Partners | Gilbert | Arizona | 85297 | — |
| Xenoscience, Inc. | Phoenix | Arizona | 85004 | — |
| Advanced Research Center, Inc | Anaheim | California | 92805 | — |
| Axiom Research, LLC | Colton | California | 92324 | — |
| ATP Clinical Research, Inc. | Costa Mesa | California | 92626 | — |
| Sun Valley Research Center, Inc. | Imperial | California | 92251 | — |
| Senior Clinical Trials | Laguna Hills | California | 92653 | — |
| Artemis Institute for Clinical Research | Riverside | California | 92503 | — |
| Syrentis Clinical Research | Santa Ana | California | 92705 | — |
| Mountain Neurological Research Center | Basalt | Colorado | 81621 | — |
| Colorado Neurological Research Center, PC | Denver | Colorado | 80210 | — |
| CT Clinical Research | Cromwell | Connecticut | 06416 | — |
| Topaz Clinical Research | Apopka | Florida | 32703 | — |
| Neurology Offices of South Florida | Boca Raton | Florida | 33428 | — |
| Boynton Beach Medical Research Institute (GMI) | Boynton Beach | Florida | 33437 | — |
| K2 Medical Research - Clermont | Clermont | Florida | 34711 | — |
| Arrow Clinical Trials | Daytona Beach | Florida | 32117 | — |
| Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida | 33912 | — |
| Velocity Clinical Research, Hallandale Beach | Hallandale | Florida | 33009 | — |
| Galiz Research | Hialeah | Florida | 33016 | — |
| Infinity Clinical Research - Sunrise | Hollywood | Florida | 33024 | — |
| CNS Healthcare - Jacksonville | Jacksonville | Florida | 32256 | — |
| Charter Research | Lady Lake | Florida | 32162 | — |
| Segal Trials - West Broward Outpatient Site | Lauderhill | Florida | 33319 | — |
| ClinCloud | Maitland | Florida | 32751 | — |
| Merritt Island Medical Research, LLC | Merritt Island | Florida | 32952 | — |
| Central Miami Medical Institute (GMI) | Miami | Florida | 33125 | — |
| New Horizon Research Center | Miami | Florida | 33165 | — |
| Luminous Clinical Research | Miami | Florida | 33186 | — |
| Quantam Clinical Trials | Miami Beach | Florida | 33140 | — |
| South Florida Research Phase I-IV INC | Miami Springs | Florida | 33166 | — |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | — |
| Renstar Medical Research | Ocala | Florida | 34470 | — |
| Charter Research | Orlando | Florida | 32803 | — |
| Combined Research Orlando Phase I-IV | Orlando | Florida | 32807 | — |
| Progressive Medical Research | Port Orange | Florida | 32127 | — |
| Clinical Research of Brandon, LLC (Tampa) | Tampa | Florida | 33603 | — |
| Stedman Clinical Trials | Tampa | Florida | 33613 | — |
| Premier Research Institute at Palm Beach Neurology | West Palm Beach | Florida | 33407 | — |
| Velocity Clinical Research, Boise | Meridian | Idaho | 83642 | — |
| Northwestern Medicine Central DuPage Hospital | Winfield | Illinois | 60190 | — |
| Ascension Via Christi Research | Wichita | Kansas | 67214 | — |
| Neuro Medical Clinic of Central Louisiana, LLC | Alexandria | Louisiana | 71301 | — |
| Boston Neuro Research Center | North Dartmouth | Massachusetts | 02747 | — |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | — |
| CCT Research - Papillion Research Center | Papillion | Nebraska | 68046 | — |
| Advanced Clinical Institute, Inc | West Long Branch | New Jersey | 07764 | — |
| Albuquerque Neuroscience, Inc | Albuquerque | New Mexico | 87109 | — |
| Dent Neurologic Institute | Amherst | New York | 14226 | — |
| Parker Jewish Institute for Health Care & Rehabilitation | New Hyde Park | New York | 11040-1433 | — |
| Mid Hudson Medical Research | New Windsor | New York | 12553 | — |
| NY Neurology Associates | New York | New York | 10003 | — |
| University of Rochester Medical Center - Alzheimer's Disease Care, Research and Education Program | Rochester | New York | 14620 | — |
| Five Town Neuroscience Research | Woodmere | New York | 11598 | — |
| Triad Clinical Trials, LLC | Greensboro | North Carolina | 27410 | — |
| Alzheimer's Memory Center | Matthew | North Carolina | 28105 | — |
| Insight Clinical Trials LLC | Beachwood | Ohio | 44122 | — |
| NeuroScience Research Center, LLC | Canton | Ohio | 44718 | — |
| Dayton Center for Neurological Disorders | Centerville | Ohio | 45459 | — |
| Summit Research Network, LLC | Portland | Oregon | 97210 | — |
| Brian Abaluck, LLC | Malvern | Pennsylvania | 19355 | — |
| Global Medical Institutes/Scranton Medical Institute - Moosic Division | Moosic | Pennsylvania | 18507 | — |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | 02914 | — |
| Palmetto Clinical Research | Summerville | South Carolina | 29485 | — |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | — |
| Senior Adults Specialty Research, Inc | Austin | Texas | 78757 | — |
| Texas Neurology, PA | Dallas | Texas | 75206 | — |
| Baylor Scott & White Research Institute | Dallas | Texas | 75231 | — |
| Mt. Olympus Medical Research, LLC | Katy | Texas | 77450 | — |
| Grayline Research Center | Wichita Falls | Texas | 76309 | — |
| Green Mountain Research Institute, Inc. | Rutland | Vermont | 05701 | — |
| Re:Cognition Health | Fairfax | Virginia | 22031 | — |
| Memory and Brain Wellness Center at Harborview | Seattle | Washington | 98104 | — |
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 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04994483, 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 May 25, 2025 · Synced Oct 19, 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 NCT04994483 live on ClinicalTrials.gov.