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Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease (REFOCUS-ALZ)

Primary Purpose

Alzheimer Disease

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Simufilam
Placebo
Sponsored by
Cassava Sciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - 87 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
  6. The subject has been a non-smoker 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.

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
  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 > 35.0.
  13. History or diagnosis of clinically significant cardiac disease
  14. Prescribed aducanumab.
  15. COVID-19 infection within 3 months of screening. If no history of a prior COVID-19 infection, subject must be fully vaccinated for COVID-19 at least 2 weeks prior to randomization.

Sites / Locations

  • Banner Alzheimer's Institute
  • Arizona Neuroscience Research, LLC
  • Clinical Endpoints
  • Banner Sun Health Research Institute
  • Banner Alzheimer's Institute - Tucson
  • North County Neurology Associates
  • Neuro-Pain Medical Center
  • Neurology Center of North Orange County
  • Healthy Brain Clinic
  • California Research Insitute
  • Shankle Clinic and Hoag Memorial Hospital Presbyterian
  • Pacific Research Network, LLC
  • Nuvance Health Medical Practice CT, Inc. - Associated Neurologists, PC
  • Ki Health Partners, LLC
  • JEM Research Institute
  • Parkinson's Disease and Movement Disorders Center of Boca Raton
  • Clinical Research of Brandon, LLC
  • Brain Matters Research Inc
  • Indago Research and Health Center, Inc.
  • Alphab Global Research
  • Mind Institute at Miami Jewish Health
  • Brainstorm Research
  • Health Synergy Clinical Research
  • K2 Medical Research
  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
  • Quantum Laboratories
  • Intercoastal Medical Group - Sarasota
  • Alzheimer's Research & Treatment Center
  • Brain Matters Research Inc
  • USF Health - Byrd Alzheimer's Center and Research Institute
  • Alzheimer's Research & Treatment Center
  • Conquest Research
  • Columbus Memory Center, PC
  • Accel Research Sites - NeuroStudies
  • Great Lakes Clinical Trials
  • Advocate Aurora Health
  • University of Kentucky Sanders-Brown Center on Aging
  • Neurology Center of New England
  • ActivMed Practices & Research, LLC
  • Boston Center for Memory
  • Office of Donald S. Marks, M.D., P.C.
  • MedVadis Research
  • Global Medical Institutes, LLC
  • The Cognitive and Research Center of New Jersey (CRCNJ)
  • Advanced Memory Research Institute of NJ
  • Neurology Specialists of Monmouth County
  • Albany Medical Center
  • Neurological Associates of Albany
  • Integrative Clinical Trials
  • SPRI Clinical Trials Brooklyn
  • Velocity Clinical Research, Formerly Clarity Clinical Research
  • Richmond Behavioral Associates
  • Accellacare Research of Winston-Salem
  • Ohio State University
  • Neurology Diagnostics
  • Neuro-Behavioral Clinical Research (NBCR)
  • Center for Cognitive Health - Portland
  • The Clinical Trial Center
  • Keystone Clinical Studies, LLC
  • KCA Neurology, PLLC
  • Neurology Consultants of Dallas, PA
  • Cedar Health Research
  • The Memory Clinic - Bennington
  • Northwest Clinical Research Center
  • Medical College of Wisconsin
  • OCT Research ULC DBA Okanagan Clinical Trials
  • Djavad Mowafaghian Centre for Brain Health
  • Centre Hospitalier Universitaire Dr-Georges-L.-Dumont (CHUDGLD)
  • True North Clinical Research - Halifax
  • True North Clinical Research - New Minas
  • St. Joseph's Health Care London
  • Ottawa Memory Clinic
  • Kawartha Centre - Redefining Healthy Aging
  • Toronto Memory Program
  • The Centre for Memory and Aging
  • Recherches Neuro-Hippocampe Inc.
  • Chonnam National University Hospital
  • Hanyang University Guri Hospital
  • Seoul National University Bundang Hospital
  • Gachon University Gil Hospital
  • Inha University Medical Center
  • Kyungpook National University Chilgok Hospital
  • Korea University Anam Hospital
  • HanYang University Hospital
  • Asan Medical Center
  • Santa Cruz Behavioral PSC
  • Inspira Clinical Research
  • Barbara Diaz Hernandez Md Research, Inc.
  • Instituto De Neurologia Dra. Ivonne Fraga

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Simufilam 50 mg

Simufilam 100 mg

Arm Description

Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks

Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 weeks

Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 weeks

Outcomes

Primary Outcome Measures

Change from baseline in the 12-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12)
The change from baseline to Week 76 in the ADAS-Cog12, a psychometrician-administered battery comprised of several cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Scores range from 0 (best) to 80 (worst).
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
The change from baseline to Week 76 in the ADCS-ADL, a 23-item study partner questionnaire that covers both basic activities of daily living (ADL) and more complex ADL or instrumental ADL. Scores range from 0 to 78, with a lower score indicating greater severity of functional loss.

Secondary Outcome Measures

Change from baseline in the integrated Alzheimer's Disease Rating Scale (iADRS)
The change from baseline to Week 76 in the iADRS, where scores range from 0 to 146 with lower scores indicating worse performance.
Change from baseline in the Neuropsychiatric Inventory (NPI)
The change from baseline to Week 76 in the NPI, a 12-item study partner interview, which records the frequency and severity of common neuropsychiatric symptoms in dementia, as well as the level of study partner distress due to these neuropsychiatric problems. Scores range from 0 to 144, with higher scores indicating more frequent and severe symptoms, and greater levels of partner distress.
Change from baseline in the MMSE
The change from baseline to Week 76 in the MMSE, a set of standardized questions covering several target areas: orientation, registration, attention and calculation, short-term verbal recall, naming, repetition, 3-step command, reading, writing, and visuospatial cognitive assessment. Lower scores indicate more severe impairment.
Change from baseline in the Clinical Dementia Rating Sum of Boxes (CDR-SB)
The change from baseline to Week 76 in the CDR-SB, which characterizes 6 domains of cognitive and functional performance applicable to AD and related dementias: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Higher scores indicate more severe impairment.
Change from baseline in the Zarit Burden Interview (ZBI)
The change from baseline to Week 76 in the ZBI, a 22-item study partner questionnaire designed to assess the stress or burden experienced by caregivers of people with dementia, with a higher score indicating greater stress or burden.
Changes from baseline in CSF neurogranin, neurofilament light chain, total tau, phospho-tau181 (P-tau181) and/or phospho-tau217 (P-tau217), soluble triggering receptor expressed on myeloid cells 2 (sTREM2), and Aβ42
Changes from baseline in CSF biomarkers of AD pathology, neurodegeneration, and neuroinflammation.
Changes from baseline in brain volume via MRI
Changes from baseline in hippocampus, ventricles, and whole brain volume.
Changes from baseline in amyloid and tau PET
Changes from baseline in amyloid and tau deposition in the brain
Changes from baseline in plasma biomarkers P-tau181, P-tau217, and neurofilament light chain
Change from baseline in plasma biomarkers of AD pathology and neurodegeneration
Change from baseline in plasma biomarker SavaDx
SavaDx is a novel plasma biomarker

Full Information

First Posted
August 9, 2021
Last Updated
September 13, 2023
Sponsor
Cassava Sciences, Inc.
Collaborators
Premier Research Group plc
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1. Study Identification

Unique Protocol Identification Number
NCT05026177
Brief Title
Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease
Acronym
REFOCUS-ALZ
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 76-week Study Evaluating the Safety and Efficacy of Two Doses of Simufilam in Subjects With Mild-to-Moderate Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cassava Sciences, Inc.
Collaborators
Premier Research Group plc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A 76-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild-to-moderate Alzheimer's disease (AD) for 76 weeks. Approximately 1083 participants will be randomized (1:1:1) to receive either placebo, 50 mg tablets of simufilam, or 100 mg tablets of simufilam, twice daily, for 76 weeks. Clinic visits will occur 4 weeks after the baseline visit, and then every 12 weeks until the end of the study. The safety of simufilam, and its efficacy in enhancing cognition and slowing cognitive and functional decline will be evaluated.
Detailed Description
The primary objective of this study is to investigate the safety and efficacy of simufilam (PTI-125) in enhancing cognition and slowing cognitive and functional decline following 76-week, repeat-dose oral administration in participants with mild-to-moderate AD. Secondary objectives are to assess neuropsychiatric symptoms and to replicate the cerebrospinal fluid (CSF) biomarker effects observed in the two Phase 2 studies (PTI-125-03 and PTI-125-02) after 76 weeks of simufilam treatment. A third objective is to investigate the effect of simufilam treatment on plasma biomarkers as well as anatomical correlates of disease progression (brain volume [hippocampus, ventricles and whole brain]; and amyloid and tau deposition in the brain). A limited number of research sites will be invited to participate in sub-studies to assess the impact of simufilam on anatomical and biomarker endpoints, including: change from Baseline in CSF biomarkers (30 subjects/group); brain volume via magnetic resonance imaging (MRI) (50 subjects/group); and amyloid and tau positron emission tomography (PET) (40 and 50 subjects/group, respectively). Participants in both PET sub-studies will be required to have an MRI during the Screening Period and provide plasma for a biomarker sub-study. Participants in the tau PET sub-study will also provide additional plasma for a pharmacokinetic (PK) exposure response analysis. Changes from baseline for these imaging and fluid biomarkers represent additional secondary endpoints. The 90 subjects (30 per group) in the CSF sub-study will undergo lumbar puncture during the Screening Period and again at the Week 76 End-of-Treatment Visit to collect CSF biomarkers. Safety will be evaluated by adverse event monitoring, vital signs, clinical labs, and the Columbia Suicide Severity Rating Scale at every visit. Subjects will undergo MRI during screening to ensure entry criteria are met (unless recent MRI confirms entry criteria); however, 150 subjects (50 subjects per treatment group) will also undergo repeat MRI assessments at Weeks 40 and 76 to assess both long-term safety and drug impact on brain volume as noted above. Resting electrocardiograms will be conducted at Baseline (Study Day 1) and Weeks 4, 40 and 76. A complete physical and neurological examination will be performed at screening, and brief examinations will be performed at all other visits. Weight will be measured during the Screening Period, at Baseline (Study Day 1) and at all other visits. An independent Data Safety Monitoring Board (DSMB) will meet periodically to review subject safety assessments and determine if dosing may continue. A charter will be developed with specific guidance for the DSMB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomized treatments will be assigned by subject numbers in a randomly generated numeric sequence. Randomization (1:1:1) will be stratified by low or high Mini-Mental State Exam (MMSE; 16-20 and 21-27). The randomization code will not be revealed to study subjects, Investigators, clinical staff, study monitors or the Sponsor until all subjects have completed therapy and the database has been finalized and locked.
Allocation
Randomized
Enrollment
1083 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks
Arm Title
Simufilam 50 mg
Arm Type
Experimental
Arm Description
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 weeks
Arm Title
Simufilam 100 mg
Arm Type
Experimental
Arm Description
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 weeks
Intervention Type
Drug
Intervention Name(s)
Simufilam
Other Intervention Name(s)
PTI-125
Intervention Description
Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 76 weeks at a dose of 50 mg or 100 mg.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo given b.i.d. for 76 weeks
Primary Outcome Measure Information:
Title
Change from baseline in the 12-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12)
Description
The change from baseline to Week 76 in the ADAS-Cog12, a psychometrician-administered battery comprised of several cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Scores range from 0 (best) to 80 (worst).
Time Frame
Baseline (Study Day 1) to Week 76
Title
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Description
The change from baseline to Week 76 in the ADCS-ADL, a 23-item study partner questionnaire that covers both basic activities of daily living (ADL) and more complex ADL or instrumental ADL. Scores range from 0 to 78, with a lower score indicating greater severity of functional loss.
Time Frame
Baseline (Study Day 1) to Week 76
Secondary Outcome Measure Information:
Title
Change from baseline in the integrated Alzheimer's Disease Rating Scale (iADRS)
Description
The change from baseline to Week 76 in the iADRS, where scores range from 0 to 146 with lower scores indicating worse performance.
Time Frame
Baseline (Study Day 1) to Week 76
Title
Change from baseline in the Neuropsychiatric Inventory (NPI)
Description
The change from baseline to Week 76 in the NPI, a 12-item study partner interview, which records the frequency and severity of common neuropsychiatric symptoms in dementia, as well as the level of study partner distress due to these neuropsychiatric problems. Scores range from 0 to 144, with higher scores indicating more frequent and severe symptoms, and greater levels of partner distress.
Time Frame
Baseline (Study Day 1) to Week 76
Title
Change from baseline in the MMSE
Description
The change from baseline to Week 76 in the MMSE, a set of standardized questions covering several target areas: orientation, registration, attention and calculation, short-term verbal recall, naming, repetition, 3-step command, reading, writing, and visuospatial cognitive assessment. Lower scores indicate more severe impairment.
Time Frame
Baseline (Study Day 1) to Week 76
Title
Change from baseline in the Clinical Dementia Rating Sum of Boxes (CDR-SB)
Description
The change from baseline to Week 76 in the CDR-SB, which characterizes 6 domains of cognitive and functional performance applicable to AD and related dementias: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Higher scores indicate more severe impairment.
Time Frame
Baseline (Study Day 1) to Week 76
Title
Change from baseline in the Zarit Burden Interview (ZBI)
Description
The change from baseline to Week 76 in the ZBI, a 22-item study partner questionnaire designed to assess the stress or burden experienced by caregivers of people with dementia, with a higher score indicating greater stress or burden.
Time Frame
Baseline (Study Day 1) to Week 76
Title
Changes from baseline in CSF neurogranin, neurofilament light chain, total tau, phospho-tau181 (P-tau181) and/or phospho-tau217 (P-tau217), soluble triggering receptor expressed on myeloid cells 2 (sTREM2), and Aβ42
Description
Changes from baseline in CSF biomarkers of AD pathology, neurodegeneration, and neuroinflammation.
Time Frame
Baseline (Study Day 1) to Week 76
Title
Changes from baseline in brain volume via MRI
Description
Changes from baseline in hippocampus, ventricles, and whole brain volume.
Time Frame
Baseline (Study Day 1) to Week 76
Title
Changes from baseline in amyloid and tau PET
Description
Changes from baseline in amyloid and tau deposition in the brain
Time Frame
Baseline (Study Day 1) to Week 76
Title
Changes from baseline in plasma biomarkers P-tau181, P-tau217, and neurofilament light chain
Description
Change from baseline in plasma biomarkers of AD pathology and neurodegeneration
Time Frame
Baseline (Study Day 1) to Week 76
Title
Change from baseline in plasma biomarker SavaDx
Description
SavaDx is a novel plasma biomarker
Time Frame
Baseline (Study Day 1) to Week 76

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
87 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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. Evidence for AD pathophysiology, confirmed prior to or during screening. MMSE score ≥ 16 and ≤ 27 at screening. Clinical Dementia Rating - Global Score must be 0.5, 1 or 2. 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. The subject has not been a cigarette smoker or chewed tobacco for at least 3 years. Availability of a study partner. 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. 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: A neurologic condition other than AD that significantly contributes to the subject's dementia. Any current primary psychiatric diagnosis other than AD if it is likely to confound cognitive assessment or ability to comply with study procedures. 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). Suicidal ideation during the past 3 months or suicidal behavior during the past 12 months. Alcohol or substance use disorder within 2 years of screening. MRI presence of cerebral vascular or other significant pathology. History of transient ischemic attack or stroke within 12 months of screening. Seizure within 12 months of screening. Severe head trauma or head trauma considered likely to be contributing to the subject's cognitive impairment. Sleep apnea that is considered likely to be contributing to the subject's cognitive impairment. Insufficiently controlled diabetes mellitus or hypertension. Body mass index < 18.5 or > 37.5. History or diagnosis of clinically significant cardiac disease. Currently or previously prescribed/administered aducanumab, lecanemab, or any anti-amyloid monoclonal antibody, more than 2 doses.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Kupiec, MD
Organizational Affiliation
Cassava Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Arizona Neuroscience Research, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Clinical Endpoints
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Banner Alzheimer's Institute - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
North County Neurology Associates
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Facility Name
Neuro-Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Healthy Brain Clinic
City
Long Beach
State/Province
California
ZIP/Postal Code
90804
Country
United States
Facility Name
California Research Insitute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Shankle Clinic and Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Pacific Research Network, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Nuvance Health Medical Practice CT, Inc. - Associated Neurologists, PC
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Ki Health Partners, LLC
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Clinical Research of Brandon, LLC
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Brain Matters Research Inc
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Indago Research and Health Center, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Alphab Global Research
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Mind Institute at Miami Jewish Health
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Brainstorm Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Health Synergy Clinical Research
City
Okeechobee
State/Province
Florida
ZIP/Postal Code
34972
Country
United States
Facility Name
K2 Medical Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Quantum Laboratories
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Intercoastal Medical Group - Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Alzheimer's Research & Treatment Center
City
Stuart
State/Province
Florida
ZIP/Postal Code
34997
Country
United States
Facility Name
Brain Matters Research Inc
City
Stuart
State/Province
Florida
ZIP/Postal Code
34997
Country
United States
Facility Name
USF Health - Byrd Alzheimer's Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Alzheimer's Research & Treatment Center
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Conquest Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Columbus Memory Center, PC
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
Accel Research Sites - NeuroStudies
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Great Lakes Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Advocate Aurora Health
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
University of Kentucky Sanders-Brown Center on Aging
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Neurology Center of New England
City
Foxboro
State/Province
Massachusetts
ZIP/Postal Code
02035
Country
United States
Facility Name
ActivMed Practices & Research, LLC
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Boston Center for Memory
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Office of Donald S. Marks, M.D., P.C.
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
Country
United States
Facility Name
MedVadis Research
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Global Medical Institutes, LLC
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
The Cognitive and Research Center of New Jersey (CRCNJ)
City
Springfield
State/Province
New Jersey
ZIP/Postal Code
07081
Country
United States
Facility Name
Advanced Memory Research Institute of NJ
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Neurology Specialists of Monmouth County
City
West Long Branch
State/Province
New Jersey
ZIP/Postal Code
07764
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Neurological Associates of Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Integrative Clinical Trials
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
SPRI Clinical Trials Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Velocity Clinical Research, Formerly Clarity Clinical Research
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Accellacare Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Neurology Diagnostics
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Neuro-Behavioral Clinical Research (NBCR)
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Facility Name
Center for Cognitive Health - Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
The Clinical Trial Center
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Keystone Clinical Studies, LLC
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Facility Name
KCA Neurology, PLLC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Neurology Consultants of Dallas, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Cedar Health Research
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
The Memory Clinic - Bennington
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
OCT Research ULC DBA Okanagan Clinical Trials
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2Z9
Country
Canada
Facility Name
Djavad Mowafaghian Centre for Brain Health
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Facility Name
Centre Hospitalier Universitaire Dr-Georges-L.-Dumont (CHUDGLD)
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 2Z3
Country
Canada
Facility Name
True North Clinical Research - Halifax
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1N2
Country
Canada
Facility Name
True North Clinical Research - New Minas
City
New Minas
State/Province
Nova Scotia
ZIP/Postal Code
B4N 3R7
Country
Canada
Facility Name
St. Joseph's Health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 0A7
Country
Canada
Facility Name
Ottawa Memory Clinic
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Z 1G3
Country
Canada
Facility Name
Kawartha Centre - Redefining Healthy Aging
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H2P4
Country
Canada
Facility Name
Toronto Memory Program
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Facility Name
The Centre for Memory and Aging
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Recherches Neuro-Hippocampe Inc.
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8T 8J1
Country
Canada
Facility Name
Chonnam National University Hospital
City
Gwangju
State/Province
Dong-gu
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital
City
Guri-si
State/Province
Gyeonggi-do
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Namdong-gu
State/Province
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Inha University Medical Center
City
Incheon
State/Province
Jung-go
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
State/Province
North Gyeongsang Province
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seongbuk-gu
State/Province
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
HanYang University Hospital
City
Seongdong-gu
State/Province
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Santa Cruz Behavioral PSC
City
Bayamón
ZIP/Postal Code
00961
Country
Puerto Rico
Facility Name
Inspira Clinical Research
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Barbara Diaz Hernandez Md Research, Inc.
City
San Juan
ZIP/Postal Code
00926
Country
Puerto Rico
Facility Name
Instituto De Neurologia Dra. Ivonne Fraga
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs