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Showing 1–11 of 11 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: simufilam Clear all
Terminated Phase 3 Interventional Results available

Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease

NCT05026177
View directory record Official record
Conditions
Alzheimer Disease
Interventions
Simufilam, Placebo
Drug
Lead sponsor
Cassava Sciences, Inc.
Industry
Eligibility
50 Years to 87 Years
Enrollment
1,125 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
65
States / cities
Phoenix, Arizona • Scottsdale, Arizona • Sun City, Arizona + 57 more
Source: ClinicalTrials.gov public record
Updated Sep 21, 2025 · Synced Sep 2, 2026, 10:15 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Simufilam Following a Single Oral Dose in Healthy Male Subjects

NCT06195319
View directory record Official record
Conditions
Absorption, Metabolism, Excretion
Interventions
Simufilam
Drug
Lead sponsor
Cassava Sciences, Inc.
Industry
Eligibility
18 Years to 55 Years · Male only
Enrollment
8 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Mar 19, 2025 · Synced Sep 2, 2026, 10:15 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Pharmacokinetic Study of Simufilam in Subjects With Impaired Hepatic Function

NCT06390410
View directory record Official record
Conditions
Hepatic Insufficiency
Interventions
Simufilam
Drug
Lead sponsor
Cassava Sciences, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
27 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024
U.S. locations
3
States / cities
Lake Forest, California • Miami, Florida • Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Jan 6, 2025 · Synced Sep 2, 2026, 10:15 PM EDT
Completed Phase 2 Interventional Results available

PTI-125 for Mild-to-moderate Alzheimer's Disease Patients

NCT03748706
View directory record Official record
Conditions
Alzheimer Disease
Interventions
PTI-125, 100 mg tablets
Drug
Lead sponsor
Pain Therapeutics
Industry
Eligibility
50 Years to 85 Years
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019
U.S. locations
2
States / cities
DeSoto, Texas • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Jul 6, 2021 · Synced Sep 2, 2026, 10:15 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

A Safety Study of PTI-125 in Healthy Volunteers

NCT03784300
View directory record Official record
Conditions
Alzheimer Disease, Early Onset, Alzheimer Disease
Interventions
50 mg PTI-125, 100 mg PTI-125, 200 mg PTI-125
Drug
Lead sponsor
Pain Therapeutics
Industry
Eligibility
18 Years to 45 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2018
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated May 9, 2021 · Synced Sep 2, 2026, 10:15 PM EDT
Completed Phase 3 Interventional Results available

Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease

NCT04994483
View directory record Official record
Conditions
Alzheimer Disease
Interventions
Simufilam, Placebo
Drug
Lead sponsor
Cassava Sciences, Inc.
Industry
Eligibility
50 Years to 87 Years
Enrollment
804 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
74
States / cities
Chandler, Arizona • Gilbert, Arizona • Phoenix, Arizona + 65 more
Source: ClinicalTrials.gov public record
Updated May 24, 2025 · Synced Sep 2, 2026, 10:15 PM EDT
Terminated Phase 2 Interventional Results available

Open-Label Extension of the PTI-125-04 Study in Mild-to-Moderate Alzheimer's Disease

NCT05352763
View directory record Official record
Conditions
Alzheimer's Disease
Interventions
simufilam
Drug
Lead sponsor
Cassava Sciences, Inc.
Industry
Eligibility
50 Years and older
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
9
States / cities
Gilbert, Arizona • Imperial, California • Delray Beach, Florida + 6 more
Source: ClinicalTrials.gov public record
Updated Aug 14, 2025 · Synced Sep 2, 2026, 10:15 PM EDT
Completed Phase 2 Interventional Results available

PTI-125 for Mild-to-moderate Alzheimer's Disease Patients

NCT04079803
View directory record Official record
Conditions
Alzheimer Disease
Interventions
Placebo oral tablet, Simufilam 100 mg tablet, Simufilam 50 mg oral tablet
Drug
Lead sponsor
Cassava Sciences, Inc.
Industry
Eligibility
50 Years to 85 Years
Enrollment
64 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
9
States / cities
Gilbert, Arizona • Surprise, Arizona • Miami, Florida + 6 more
Source: ClinicalTrials.gov public record
Updated Sep 28, 2021 · Synced Sep 2, 2026, 10:15 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers

NCT04932655
View directory record Official record
Conditions
Healthy Volunteers
Interventions
simufilam
Drug
Lead sponsor
Cassava Sciences, Inc.
Industry
Eligibility
18 Years to 45 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Aug 21, 2023 · Synced Sep 2, 2026, 10:15 PM EDT
Terminated Phase 3 Interventional Results available

Open-label Extension for Phase 3 Clinical Trials of Simufilam

NCT05575076
View directory record Official record
Conditions
Alzheimer Disease
Interventions
Simufilam
Drug
Lead sponsor
Cassava Sciences, Inc.
Industry
Eligibility
51 Years to 89 Years
Enrollment
1,081 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
107
States / cities
Chandler, Arizona • Gilbert, Arizona • Phoenix, Arizona + 94 more
Source: ClinicalTrials.gov public record
Updated May 22, 2025 · Synced Sep 2, 2026, 10:15 PM EDT
Completed Phase 2 Interventional Results available

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

NCT04388254
View directory record Official record
Conditions
Alzheimer Disease
Interventions
Simufilam 100 mg oral tablet, Placebo
Drug
Lead sponsor
Cassava Sciences, Inc.
Industry
Eligibility
50 Years to 85 Years
Enrollment
220 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
15
States / cities
Gilbert, Arizona • Surprise, Arizona • Imperial, California + 12 more
Source: ClinicalTrials.gov public record
Updated Apr 21, 2025 · Synced Sep 2, 2026, 10:15 PM EDT