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Alzheimer DiseasePhase 3NCT05575076

Open-label Extension for Phase 3 Clinical Trials of Simufilam

A Phase 3 study testing Simufilam in people with Alzheimer Disease, run by Cassava Sciences, Inc. at 134 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The goal of this open-label extension study is to assess long-term safety and tolerability of simufilam 100 mg in subjects who have completed the RETHINK-ALZ or REFOCUS-ALZ Phase 3 clinical trials. Read more about this study

Who is it for?
Ages 51 to 89 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Simufilam
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,081 participants
Where
134 sitesin 5 countries
Study dates
7 Nov 2022to 31 Jan 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 51 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Completed RETHINK-ALZ (PTI-125-07) or REFOCUS-ALZ (PTI-125-06).
  • Clinical presentation continues to be consistent with Alzheimer's disease.
  • Availability of a study partner.

Who cannot join

  • Residence in a skilled nursing facility requiring 24-hour care.
  • Evidence of a neurologic condition other than AD that significantly contributes to the subject's dementia.
  • Current clinically significant psychiatric diagnosis other than AD.
  • Unstable, clinically significant medical condition other than AD.
  • Any medical condition that in the opinion of the investigator may affect safety or ability to complete the study.

Trial locations and contacts

134 sites in 5 countries.

134 sites in 5 countries

United States107 sites

  • Albany Medical Center

    Albany, New York, 12208

  • Neurological Associates of Albany

    Albany, New York, 12208

  • Albuquerque Neuroscience, Inc

    Albuquerque, New Mexico, 87109

  • Neuro Medical Clinic of Central Louisiana, LLC

    Alexandria, Louisiana, 71301

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • Advanced Research Center, Inc.

    Anaheim, California, 92805

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Senior Adults Specialty Research, Inc

    Austin, Texas, 78757

  • Mountain Neurological Research Center

    Basalt, Colorado, 81621

  • Insight Clinical Trials LLC

    Beachwood, Ohio, 44122

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Neurology Offices of South Florida

    Boca Raton, Florida, 33428

  • Integrative Clinical Trials, LLC

    Brooklyn, New York, 11229

  • SPRI Clinical Trials Brooklyn

    Brooklyn, New York, 11235

  • NeuroScience Research Center, LLC

    Canton, Ohio, 44718

  • North County Neurology Associates

    Carlsbad, California, 92011

  • Dayton Center for Neurological Disorders

    Centerville, Ohio, 45459

  • MDFirst Research

    Chandler, Arizona, 85286

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • K2 Medical Research- Ocoee

    Clermont, Florida, 34711

  • Axiom Research, LLC

    Colton, California, 92324

  • Columbus Memory Center, PC

    Columbus, Georgia, 31909

  • the Ohio State University

    Columbus, Ohio, 43221

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626

  • Texas Neurology, PA

    Dallas, Texas, 75206

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75231

  • Neurology Diagnostics

    Dayton, Ohio, 45459

  • Arrow Clinical Trials

    Daytona Beach, Florida, 32117

  • Accel Research Sites - NeuroStudies

    Decatur, Georgia, 30030

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Colorado Neurological Research Center, PC

    Denver, Colorado, 80210

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • Velocity Clinical Research, Formerly Clarity Clinical Research

    East Syracuse, New York, 13057

  • Re:Cognition Health

    Fairfax, Virginia, 22031

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Neurology Center of New England

    Foxborough, Massachusetts, 02035

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • CCT Research - Gilbert Neurology Partners

    Gilbert, Arizona, 85297

  • Triad Clinical Trials, LLC

    Greensboro, North Carolina, 27410

  • Velocity Clinical Research, Hallandale Beach

    Hallandale, Florida, 33009

  • Galiz Research

    Hialeah, Florida, 33016

  • Infinity Clinical Research - Sunrise

    Hollywood, Florida, 33024

  • Luminous Clinical Research

    Homestead, Florida, 33030

  • Sun Valley Research Center, Inc.

    Imperial, California, 92251

  • CNS Healthcare - Jacksonville

    Jacksonville, Florida, 32256

  • Mt. Olympus Medical Research, LLC

    Katy, Texas, 77450

  • Charter Research

    Lady Lake, Florida, 32792

  • Senior Clinical Trials

    Laguna Hills, California, 92653

  • University of Kentucky

    Lexington, Kentucky, 40504

  • ClinCloud

    Maitland, Florida, 32751

  • Alzheimer's Memory Center

    Matthew, North Carolina, 28105

  • Velocity Clinical Research - Boise

    Meridian, Idaho, 83642

  • Merritt Island Medical Research, LLC

    Merritt Island, Florida, 32952

  • ActivMed Practices & Research, LLC

    Methuen, Massachusetts, 01844

  • Central Miami Medical Institute (GMI)

    Miami, Florida, 33125

  • Mind Institute at Miami Jewish Health

    Miami, Florida, 33137

  • New Horizon Research Center

    Miami, Florida, 33165

  • Brainstorm Research

    Miami, Florida, 33176

  • South Florida Research Phase I-IV INC

    Miami Springs, Florida, 33166

  • Patient First MD

    Middletown, New Jersey, 07748

  • Advanced Clinical Institute, Inc

    Neptune City, New Jersey, 07753

  • Parker Jewish Institute for Health Care & Rehabilitation

    New Hyde Park, New York, 11040-1433

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Mid Hudson Medical Research

    New Windsor, New York, 12553

  • NY Neurology Associates

    New York, New York, 10003

  • Shankle Clinic and Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Boston Center for Memory

    Newton, Massachusetts, 02459

  • Neuro-Behavioral Clinical Research

    North Canton, Ohio, 44720

  • Boston Neuro Research Center

    North Dartmouth, Massachusetts, 02747

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Health Synergy Clinical Research

    Okeechobee, Florida, 34972

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Orlando, Florida, 32801

  • CCT Research - Papillion Research Center

    Papillion, Nebraska, 68046

  • Advocate Aurora Health - Advocate Memory Center

    Park Ridge, Illinois, 60068

  • Xenoscience, Inc.

    Phoenix, Arizona, 85004

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Headlands Eastern MA LLC

    Plymouth, Massachusetts, 02360

  • Keystone Clinical Studies, LLC

    Plymouth Meeting, Pennsylvania, 19462

  • Medical Research

    Port Orange, Florida, 32127

  • Summit Research Network, LLC

    Portland, Oregon, 97210

  • Center for Cognitive Health - Portland

    Portland, Oregon, 97225

  • Global Medical Institutes, LLC

    Princeton, New Jersey, 08540

  • Artemis Institute for Clinical Research

    Riverside, California, 92503

  • University of Rochester Medical Center - Alzheimer's Disease Care, Research and Education Program

    Rochester, New York, 14620

  • Pacific Research Network, LLC

    San Diego, California, 92103

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Intercoastal Medical Group - Sarasota

    Sarasota, Florida, 34239

  • Memory and Brain Wellness Center at Harborview

    Seattle, Washington, 98104

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

    Springfield, New Jersey, 07081

  • Ki Health Partners, LLC

    Stamford, Connecticut, 06905

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Richmond Behavioral Associates

    Staten Island, New York, 10314

  • Alzheimer's Research & Treatment Center

    Stuart, Florida, 34997

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • Clinical Research of Brandon, LLC (Tampa)

    Tampa, Florida, 33603

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • Advanced Memory Research Institute of NJ

    Toms River, New Jersey, 08755

  • MedVadis Research

    Waltham, Massachusetts, 02451

  • Alzheimer's Research & Treatment Center

    Wellington, Florida, 33414

  • Neurology Specialists of Monmouth County

    West Long Branch, New Jersey, 07764

  • Premier Research Institute at Palm Beach Neurology

    West Palm Beach, Florida, 33407

  • Ascension Via Christi Research

    Wichita, Kansas, 67214

  • Grayline Research Center

    Wichita Falls, Texas, 76309

  • Accellacare Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Charter Research

    Winter Park, Florida, 32792

Other trials in United States

Canada12 sites

  • True North Clinical Research - Halifax/Nova Scotia

    Halifax, Nova Scotia, B3S 1N2

  • OCT Research ULC DBA Okanagan Clinical Trials

    Kelowna, British Columbia, V1Y 1Z9

  • St. Joseph's Health Care London

    London, Ontario, N6C 5J1

  • Dr. George Dumont University Hospital Centre

    Moncton, New Brunswick, E1C 2Z3

  • True North Clinical Research - New Minas

    New Minas, Nova Scotia, B4N 3R7

  • Ottawa Memory Clinic

    Ottawa, Ontario, K1Z 1G3

  • Kawartha Centre - Redefining Healthy Aging

    Peterborough, Ontario, K9H2P4

  • Alpha Recherche Clinique

    Québec, G3K 2P8

  • Q & T Research

    Sherbrooke, Quebec, J1J 2G2

  • Diex Research - Sherbrooke

    Sherbrooke, Quebec, J1L 0H8

  • Toronto Memory Program

    Toronto, Ontario, M3B 2S7

  • The Centre for Memory and Aging

    Toronto, Ontario, M4G 3E8

Other trials in Canada

Australia7 sites

  • Delmont Consulting Suites

    Glen Iris, Victoria, 3146

  • Austin Health

    Heidelberg, Victoria, 3084

  • The University of Queensland

    Herston, Queensland, 4029

  • KaRa Institute of Neurological Diseases Pty. Ltd.

    Macquarie Park, New South Wales, 2113

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Eastern Health

    Melbourne, Victoria, 3128

  • Alzheimer's Research Australia

    Nedlands, Western Australia, 6009

Other trials in Australia

South Korea5 sites

  • Kyungpook National University Chilgok Hospital

    Daegu, Buk-gu, 41404

  • Chonnam National University Hospital

    Gwangju, Dong-gu, 61469

  • Inha Unviersity Medical Center

    Incheon, Jung-gu, 22332

  • Gachon University Gil Hospital

    Namyangju, Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

Other trials in South Korea

Puerto Rico3 sites

  • Santa Cruz Behavioral PSC

    Bayamón, 00961

  • Barbara Diaz Hernandez Md Research, Inc.

    San Juan, PR, 00926

  • Inspira Clinical Research

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: An Open-label, Long-term Extension Study to Evaluate the Safety and Tolerability of Simufilam 100 mg Tablets in Participants With Mild to Moderate Alzheimer's Disease

The goal of this open-label extension study is to assess long-term safety and tolerability of simufilam 100 mg in subjects who have completed the RETHINK-ALZ or REFOCUS-ALZ Phase 3 clinical trials.

Read the detailed description

This is a multi-national, multi-center, fixed-dose, 52-week, open-label extension study. After completing participation in either RETHINK-ALZ (PTI-125-06) or REFOCUS-ALZ (PTI-125-07), subjects will have the option to participate in this study. After the subject provides consent and the Investigator confirms the subject satisfies both inclusion and exclusion criteria, the study drug will be administered at the research site on Study Day 1 and subsequent visits will be scheduled.

We anticipate up to 1600 subjects may enroll in this study. Approximately up to 150 clinical sites in the USA, Canada, South Korea, and Australia will have the option to participate in this collaborative research effort.

For subjects electing to participate, the clinical and laboratory assessments from the Week 76 (REFOCUS-ALZ) or Week 52 (RETHINK-ALZ) End-of-Treatment visit will serve as Baseline Visit assessments for the open-label study on Study Day 1. All subjects will return in 4 weeks and every 12 weeks thereafter for safety assessments. At all post-baseline visits, subjects will report any adverse events since their last visit. In addition to adverse event monitoring, safety will be evaluated at every visit by vital signs, brief examinations, clinical laboratory tests (biochemistry, hematology, and urinalysis) and the Columbia Suicide Severity Rating Scale (C-SSRS). Study drug use since the last visit will be assessed and a new bottle of study drug will be dispensed.

The emerging subject safety assessments will be monitored throughout the study by an independent Data Safety Monitoring Board (DSMB).

Being tested
Simufilam
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SimufilamDrug

    Also called PTI-125

    simufilam 100 mg oral tablet, twice daily

Study groups in NCT05575076
Study groupRoleWhat they receive
Simufilam 100 mgExperimentalsimufilam 100 mg oral tablet, twice daily
Receives: Drug: Simufilam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events

    To evaluate the long-term safety and tolerability of simufilam 100 mg tablets in subjects who have completed one of the two double-blind simufilam phase 3 studies.

    Measured: Baseline to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2022
  2. Study start7 Nov 2022
  3. Primary completion31 Jan 2025
  4. Study completion31 Jan 2025

Why it stopped: sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label extension
Masking
None (open label)
Enrolment
1,081 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05575076
Sponsor's protocol ID
PTI-125-10
Status last verified
Feb 2025
First submitted
7 Oct 2022
Last updated
23 May 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Simufilam in people with Alzheimer Disease, run by Cassava Sciences, Inc. at 134 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, Canada, Australia, South Korea, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: Baseline to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05575076.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.

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