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Alzheimer's drug simufilam trial halted Mid-Study

NCT ID NCT05026177

Disease control Sponsor: Cassava Sciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a drug called simufilam in over 1,000 people with mild-to-moderate Alzheimer's disease. Participants took either 50 mg, 100 mg, or a placebo twice daily for 76 weeks. The goal was to see if simufilam could slow memory loss and help with daily activities. However, the trial was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
simufilam (also known as PTI-125)
What this could lead to
If it had succeeded, simufilam could have slowed cognitive decline and helped people with Alzheimer's maintain daily function for longer.
What could go wrong
This Phase 3 trial was terminated, so results are incomplete. Early-stage findings may not have translated into real-world benefits, and the drug's safety and effectiveness remain unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,125 people

The number who actually took part.

Started

Nov 2021

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 87 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Meets National Institute on Aging and Alzheimer's Association Research Framework criteria for individuals in clinical Stage 4 or 5 of the Alzheimer's continuum. 2. Evidence for AD pathophysiology, confirmed prior to or during screening. 3. MMSE score ≥ 16 and ≤ 27 at screening. 4. Clinical Dementia Rating - Global Score must be 0.5, 1 or 2. 5. If receiving background AD medications, the dosing regimen must be stable for at least 12 weeks prior to randomization. Chronic medications for conditions other than AD (such as depression) must be prescribed at a stable dose for at least 4 weeks prior to screening. 6. The subject has not been a cigarette smoker or chewed tobacco for at least 3 years. 7. Availability of a study partner. 8. Individuals who have participated in a clinical study with an investigational drug targeting the underlying AD process may be permitted to participate in this study. 9. Completed a COVID-19 vaccine primary series ("fully vaccinated") at least 2 weeks prior to randomization or had an unambiguous COVID-19 infection diagnosed more than 3 months before the start of the Screening Period. Key Exclusion Criteria: 1. A neurologic condition other than AD that significantly contributes to the subject's dementia. 2. Any current primary psychiatric diagnosis other than AD if it is likely to confound cognitive assessment or ability to comply with study procedures. 3. Geriatric Depression Scale (15-item) score \> 8 (Note - a subject with a score \> 8 may continue in screening if, in the judgment of the Investigator, the elevated score is not attributed to a major depressive episode). 4. Suicidal ideation during the past 3 months or suicidal behavior during the past 12 months. 5. Alcohol or substance use disorder within 2 years of screening. 6. MRI presence of cerebral vascular or other significant pathology. 7. History of transient ischemic attack or stroke within 12 months of screening. 8. Seizure within 12 months of screening. 9. Severe head trauma or head trauma considered likely to be contributing to the subject's cognitive impairment. 10. Sleep apnea that is considered likely to be contributing to the subject's cognitive impairment. 11. Insufficiently controlled diabetes mellitus or hypertension. 12. Body mass index \< 18.5 or \> 37.5. 13. History or diagnosis of clinically significant cardiac disease. 14. Currently or previously prescribed/administered aducanumab, lecanemab, or any anti-amyloid monoclonal antibody, more than 2 doses.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease

Contacts and locations

Locations

  • Accel Research Sites - NeuroStudies

    Decatur, Georgia, 30030, United States

  • Accellacare Research of Winston-Salem

    Winston-Salem, North Carolina, 27103, United States

  • ActivMed Practices & Research, LLC

    Methuen, Massachusetts, 01844, United States

  • Advanced Memory Research Institute of NJ

    Toms River, New Jersey, 08755, United States

  • Advocate Aurora Health

    Park Ridge, Illinois, 60068, United States

  • Albany Medical Center

    Albany, New York, 12208, United States

  • Alphab Global Research

    Jupiter, Florida, 33458, United States

  • Alzheimer's Research & Treatment Center

    Stuart, Florida, 34997, United States

  • Alzheimer's Research & Treatment Center

    Wellington, Florida, 33414, United States

  • Arizona Neuroscience Research, LLC

    Phoenix, Arizona, 85032, United States

  • Asan Medical Center

    Seoul, Songpa-gu, 05505, South Korea

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006, United States

  • Banner Alzheimer's Institute - Tucson

    Tucson, Arizona, 85718, United States

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351, United States

  • Barbara Diaz Hernandez Md Research, Inc.

    San Juan, 00926, Puerto Rico

  • Boston Center for Memory

    Newton, Massachusetts, 02459, United States

  • Brain Matters Research Inc

    Delray Beach, Florida, 33445, United States

  • Brain Matters Research Inc

    Stuart, Florida, 34997, United States

  • Brainstorm Research

    Miami, Florida, 33176, United States

  • California Research Insitute

    Los Angeles, California, 90027, United States

  • Cedar Health Research

    Irving, Texas, 75062, United States

  • Center for Cognitive Health - Portland

    Portland, Oregon, 97225, United States

  • Centre Hospitalier Universitaire Dr-Georges-L.-Dumont (CHUDGLD)

    Moncton, New Brunswick, E1C 2Z3, Canada

  • Chonnam National University Hospital

    Gwangju, Dong-gu, 61469, South Korea

  • Clinical Endpoints

    Scottsdale, Arizona, 85258, United States

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Orlando, Florida, 32801, United States

  • Clinical Research of Brandon, LLC

    Brandon, Florida, 33511, United States

  • Columbus Memory Center, PC

    Columbus, Georgia, 31909, United States

  • Conquest Research

    Winter Park, Florida, 32789, United States

  • Djavad Mowafaghian Centre for Brain Health

    Vancouver, British Columbia, V6T 1Z3, Canada

  • Gachon University Gil Hospital

    Namdong-gu, Incheon, 21565, South Korea

  • Global Medical Institutes, LLC

    Princeton, New Jersey, 08540, United States

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640, United States

  • HanYang University Hospital

    Seongdong-gu, Seoul, 04763, South Korea

  • Hanyang University Guri Hospital

    Guri-si, Gyeonggi-do, 11923, South Korea

  • Health Synergy Clinical Research

    Okeechobee, Florida, 34972, United States

  • Healthy Brain Clinic

    Long Beach, California, 90804, United States

  • Indago Research and Health Center, Inc.

    Hialeah, Florida, 33012, United States

  • Inha University Medical Center

    Incheon, Jung-go, 22332, South Korea

  • Inspira Clinical Research

    San Juan, 00918, Puerto Rico

  • Instituto De Neurologia Dra. Ivonne Fraga

    San Juan, Puerto Rico

  • Integrative Clinical Trials

    Brooklyn, New York, 11229, United States

  • Intercoastal Medical Group - Sarasota

    Sarasota, Florida, 34239, United States

  • JEM Research Institute

    Atlantis, Florida, 33462, United States

  • K2 Medical Research

    Maitland, Florida, 32751, United States

  • KCA Neurology, PLLC

    Franklin, Tennessee, 37067, United States

  • Kawartha Centre - Redefining Healthy Aging

    Peterborough, Ontario, K9H2P4, Canada

  • Keystone Clinical Studies, LLC

    Plymouth Meeting, Pennsylvania, 19462, United States

  • Ki Health Partners, LLC

    Stamford, Connecticut, 06905, United States

  • Korea University Anam Hospital

    Seongbuk-gu, Seoul, 02841, South Korea

  • Kyungpook National University Chilgok Hospital

    Daegu, North Gyeongsang Province, 61469, South Korea

  • MedVadis Research

    Waltham, Massachusetts, 02451, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Mind Institute at Miami Jewish Health

    Miami, Florida, 33137, United States

  • Neuro-Behavioral Clinical Research (NBCR)

    North Canton, Ohio, 44720, United States

  • Neuro-Pain Medical Center

    Fresno, California, 93710, United States

  • Neurological Associates of Albany

    Albany, New York, 12208, United States

  • Neurology Center of New England

    Foxborough, Massachusetts, 02035, United States

  • Neurology Center of North Orange County

    Fullerton, California, 92835, United States

  • Neurology Consultants of Dallas, PA

    Dallas, Texas, 75243, United States

  • Neurology Diagnostics

    Dayton, Ohio, 45459, United States

  • North County Neurology Associates

    Carlsbad, California, 92011, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Nuvance Health Medical Practice CT, Inc. - Associated Neurologists, PC

    Danbury, Connecticut, 06810, United States

  • OCT Research ULC DBA Okanagan Clinical Trials

    Kelowna, British Columbia, V1Y 2Z9, Canada

  • Office of Donald S. Marks, M.D., P.C.

    Plymouth, Massachusetts, 02360, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Ottawa Memory Clinic

    Ottawa, Ontario, K1Z 1G3, Canada

  • Pacific Research Network, LLC

    San Diego, California, 92103, United States

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486, United States

  • Patient First MD

    Middletown, New Jersey, 07748, United States

  • Quantum Laboratories

    Deerfield Beach, Florida, 33442, United States

  • Recherches Neuro-Hippocampe Inc.

    Ottawa, Ontario, K1Z 1G3, Canada

  • Richmond Behavioral Associates

    Staten Island, New York, 10312, United States

  • SPRI Clinical Trials Brooklyn

    Brooklyn, New York, 11235, United States

  • Santa Cruz Behavioral PSC

    Bayamón, 00961, Puerto Rico

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Shankle Clinic and Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663, United States

  • St. Joseph's Health Care London

    London, Ontario, N6C 0A7, Canada

  • The Centre for Memory and Aging

    Toronto, Ontario, Canada

  • The Clinical Trial Center

    Jenkintown, Pennsylvania, 19046, United States

  • The Cognitive and Research Center of New Jersey (CRCNJ)

    Springfield, New Jersey, 07081, United States

  • The Memory Clinic - Bennington

    Bennington, Vermont, 05201, United States

  • Toronto Memory Program

    Toronto, Ontario, M3B 2S7, Canada

  • True North Clinical Research - Halifax

    Halifax, Nova Scotia, B3S 1N2, Canada

  • True North Clinical Research - New Minas

    New Minas, Nova Scotia, B4N 3R7, Canada

  • USF Health - Byrd Alzheimer's Center and Research Institute

    Tampa, Florida, 33613, United States

  • University of Kentucky Sanders-Brown Center on Aging

    Lexington, Kentucky, 40504, United States

  • Velocity Clinical Research, Formerly Clarity Clinical Research

    East Syracuse, New York, 13057, United States

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