ClinicalTrials.gov record
Completed Phase 2 Interventional Results available

Simufilam (PTI-125), 100 mg, for Mild-to-moderate Alzheimer's Disease Patients

ClinicalTrials.gov ID: NCT04388254

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.

ClinicalTrials.gov public records Last synced Apr 22, 2026, 10:45 AM EDT

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

Study identification

NCT ID
NCT04388254
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Cassava Sciences, Inc.
Industry
Enrollment
220 participants

Conditions and interventions

Interventions

  • Placebo Drug
  • Simufilam 100 mg oral tablet Drug

Drug

Eligibility (public fields only)

Age range
50 Years to 85 Years
Sex
All
Healthy volunteers
Not listed

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 Apr 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04388254 live on ClinicalTrials.gov.

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