Simufilam (PTI-125), 100 mg, for Mild-to-moderate Alzheimer's Disease Patients
Public ClinicalTrials.gov record NCT04388254. 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 12-Month, Open-Label Safety Study of Simufilam Followed by a 6-Month Randomized Withdrawal and 6 Additional Months Open-Label in Mild-to-moderate Alzheimer's Disease Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A two-year safety study of simufilam (PTI-125) 100 mg oral tablets twice daily for participants of the previous simufilam studies as wells as additional new mild-to-moderate Alzheimer's disease subjects for a total of 200 participants. All participants will receive simufilam 100 mg tablets twice daily for one year, followed by a 6-month randomized, double-blind period where subjects will either continue on active treatment or be switched to placebo. The study concludes with an additional 6-month open-label treatment period. Clinic visits are every month or month and a half in the first year, and every 3 months in the second year with an additional visit at Month 13. Cognition and neuropsychiatric symptoms are evaluated.
Study identification
- NCT ID
- NCT04388254
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 220 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years to 85 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
- Mar 23, 2020
- Primary completion
- Nov 8, 2023
- Completion
- Nov 8, 2023
- Last update posted
- Apr 21, 2025
2020 – 2023
United States locations
- U.S. sites
- 15
- U.S. states
- 7
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cognitive Clinical Trials | Gilbert | Arizona | 85296 | — |
| Cognitive Clinical Trials | Surprise | Arizona | 85374 | — |
| Sun Valley Research Center, Inc. | Imperial | California | 92251 | — |
| Brain Matters Research | Delray Beach | Florida | 33445 | — |
| Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida | 33912 | — |
| Optimus U | Miami | Florida | 33125 | — |
| Adaptive Clinical Research, Inc | Miami Lakes | Florida | 33016 | — |
| IMIC, Inc. | Palmetto Bay | Florida | 33157 | — |
| Cognitive Clinical Trials | Bellevue | Nebraska | 68005 | — |
| Cognitive Clinical Trials | Omaha | Nebraska | 68130 | — |
| Advanced Memory Research Institute | Toms River | New Jersey | 08755 | — |
| Neuro-Behavioral Clinical Research | North Canton | Ohio | 44720 | — |
| Senior Adults Specialty Research | Austin | Texas | 78757 | — |
| Centex Studies, Inc. | Houston | Texas | 77058 | — |
| Centex Studies | McAllen | Texas | 78504 | — |
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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04388254, 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 Apr 21, 2025 · Synced Sep 12, 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 protocol, eligibility criteria, and contact information for NCT04388254 live on ClinicalTrials.gov.