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

  • MDFirst Research
  • CCT Research - Gilbert Neurology Partners
  • Xenoscience, Inc.
  • Advanced Research Center, Inc
  • Axiom Research, LLC
  • ATP Clinical Research, Inc.
  • Sun Valley Research Center, Inc.
  • Senior Clinical Trials
  • Artemis Institute for Clinical Research
  • Syrentis Clinical Research
  • Mountain Neurological Research Center
  • Colorado Neurological Research Center, PC
  • CT Clinical Research
  • Topaz Clinical Research
  • Neurology Offices of South Florida
  • Boynton Beach Medical Research Institute (GMI)
  • K2 Medical Research - Clermont
  • Arrow Clinical Trials
  • Neuropsychiatric Research Center of Southwest Florida
  • Velocity Clinical Research, Hallandale Beach
  • Galiz Research
  • Luminous Clinical Research
  • CNS Healthcare - Jacksonville
  • Charter Research
  • Segal Trials - West Broward Outpatient Site
  • ClinCloud
  • Merritt Island Medical Research, LLC
  • Quantam Clinical Trials
  • South Florida Research Phase I-IV INC
  • Central Miami Medical Institute (GMI)
  • New Horizon Research Center
  • Suncoast Clinical Research, Inc.
  • Renstar Medical Research
  • Combined Research Orlando Phase I-IV
  • Progressive Medical Research
  • Infinity Clinical Research - Sunrise
  • Clinical Research of Brandon, LLC (Tampa)
  • Stedman Clinical Trials
  • Premier Research Institute at Palm Beach Neurology
  • Charter Research
  • Velocity Clinical Research, Boise
  • Northwestern Medicine Central DuPage Hospital
  • Ascension Via Christi Research
  • Neuro Medical Clinic of Central Louisiana, LLC
  • Boston Neuro Research Center
  • Clinical Research Professionals
  • CCT Research - Papillion Research Center
  • Advanced Clinical Institute, Inc
  • Albuquerque Neuroscience, Inc
  • Dent Neurologic Institute
  • Parker Jewish Institute for Health Care & Rehabilitation
  • Mid Hudson Medical Research
  • NY Neurology Associates
  • University of Rochester Medical Center - Alzheimer's Disease Care, Research and Education Program
  • Five Town Neuroscience Research
  • Triad Clinical Trials, LLC
  • Alzheimer's Memory Center
  • Insight Clinical Trials LLC
  • NeuroScience Research Center, LLC
  • Dayton Center for Neurological Disorders
  • Summit Research Network, LLC
  • Brian Abaluck, LLC
  • Global Medical Institutes/Scranton Medical Institute - Moosic Division
  • Rhode Island Mood & Memory Research Institute
  • Palmetto Clinical Research
  • FutureSearch Trials of Neurology
  • Senior Adults Specialty Research, Inc
  • Texas Neurology, PA
  • Baylor Scott & White Research Institute
  • Mt. Olympus Medical Research, LLC
  • Grayline Research Center
  • Green Mountain Research Institute, Inc.
  • Re:Cognition Health
  • Memory and Brain Wellness Center at Harborview
  • KaRa MINDS
  • The University of Queensland
  • Impact Health Pty Ltd.
  • Eastern Health
  • Delmont Private Hospital
  • Austin Health
  • The Alfred Hospital
  • Royal Melbourne Hospital
  • Australian Alzheimer's Research Foundation
  • LMC Clinical Research - London
  • Bluewater Clinical Research Group Inc
  • Q & T Research
  • Diex Research Sherbrooke Inc.
  • Alpha Recherche Clinique

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Simufilam 100 mg

Arm Description

Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks

Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 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 52 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 52 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 52 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 52 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 each of the 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 Mini-Mental State Exam (MMSE)
The change from baseline to Week 52 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 52 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 52 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 plasma phospho-tau181 (P-tau181) and/or phospho-tau217 (P-tau217), and neurofilament light chain.
Change from baseline in plasma biomarkers of AD pathology, neurodegeneration, and neuroinflammation.
Changes from baseline in the plasma SavaDx biomarker
Change from baseline in SavaDx, a novel plasma biomarker

Full Information

First Posted
July 29, 2021
Last Updated
September 2, 2023
Sponsor
Cassava Sciences, Inc.
Collaborators
Premier Research Group plc
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1. Study Identification

Unique Protocol Identification Number
NCT04994483
Brief Title
Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease
Acronym
RETHINK-ALZ
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Study Evaluating the Safety and Efficacy of Simufilam 100 mg Tablets 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 3, 2021 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (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 52-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild-to-moderate Alzheimer's disease (AD) for 52 weeks. Approximately 750 participants will be randomized (1:1) to receive either placebo or 100 mg tablets of simufilam, twice daily, for 52 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 52-week, repeat-dose oral administration in participants with mild-to-moderate AD. Secondary objectives include the assessment of simufilam's effect on neuropsychiatric symptoms and caregiver burden. A third objective is to investigate the effect of simufilam treatment on plasma biomarkers. A limited number of research sites will be invited to participate in the pharmacokinetic (PK) and plasma biomarker sub-study. Collection of PK samples will enable an exposure-response analysis. Approximately 100 subjects will participate (50 per group). Plasma samples will be collected during the Screening Visit and again at Weeks 28 and 52. Change from Baseline for plasma biomarkers represent additional secondary endpoints. 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 magnetic resonance imaging (MRI) during screening to ensure entry criteria are met (unless recent MRI confirms entry criteria). Resting electrocardiograms will be conducted at Baseline (Study Day 1) and Weeks 4, 28, and 52. 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
Model Description
Approximately 750 patients will be enrolled into the study. All patients will be randomized (1:1) to receive either placebo or 100 mg tablets of simufilam, twice daily, for 52 weeks.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomized treatments will be assigned by subject numbers in a randomly generated numeric sequence. Randomization (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
750 (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 52 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 52 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 52 weeks at a dose of 100 mg.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo given b.i.d. for 52 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 52 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 52
Title
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Description
The change from baseline to Week 52 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 52
Secondary Outcome Measure Information:
Title
Change from baseline in the integrated Alzheimer's Disease Rating Scale (iADRS)
Description
The change from baseline to Week 52 in the iADRS, where scores range from 0 to 146 with lower scores indicating worse performance.
Time Frame
Baseline (Study Day 1) to Week 52
Title
Change from baseline in the Neuropsychiatric Inventory (NPI)
Description
The change from baseline to Week 52 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 each of the 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 52
Title
Change from baseline in the Mini-Mental State Exam (MMSE)
Description
The change from baseline to Week 52 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 52
Title
Change from baseline in the Clinical Dementia Rating Sum of Boxes (CDR-SB)
Description
The change from baseline to Week 52 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 52
Title
Change from baseline in the Zarit Burden Interview (ZBI)
Description
The change from baseline to Week 52 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 52
Title
Changes from baseline in plasma phospho-tau181 (P-tau181) and/or phospho-tau217 (P-tau217), and neurofilament light chain.
Description
Change from baseline in plasma biomarkers of AD pathology, neurodegeneration, and neuroinflammation.
Time Frame
Baseline (Study Day 1) to Week 52
Title
Changes from baseline in the plasma SavaDx biomarker
Description
Change from baseline in SavaDx, a novel plasma biomarker
Time Frame
Baseline (Study Day 1) to Week 52

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 either 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
MDFirst Research
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85286
Country
United States
Facility Name
CCT Research - Gilbert Neurology Partners
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Xenoscience, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Advanced Research Center, Inc
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Axiom Research, LLC
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
ATP Clinical Research, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Sun Valley Research Center, Inc.
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Facility Name
Senior Clinical Trials
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Mountain Neurological Research Center
City
Basalt
State/Province
Colorado
ZIP/Postal Code
81621
Country
United States
Facility Name
Colorado Neurological Research Center, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
CT Clinical Research
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Topaz Clinical Research
City
Apopka
State/Province
Florida
ZIP/Postal Code
32703
Country
United States
Facility Name
Neurology Offices of South Florida
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
Boynton Beach Medical Research Institute (GMI)
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
K2 Medical Research - Clermont
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Facility Name
Arrow Clinical Trials
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Neuropsychiatric Research Center of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Velocity Clinical Research, Hallandale Beach
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Galiz Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Luminous Clinical Research
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
CNS Healthcare - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Charter Research
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Segal Trials - West Broward Outpatient Site
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
ClinCloud
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Merritt Island Medical Research, LLC
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32952
Country
United States
Facility Name
Quantam Clinical Trials
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
South Florida Research Phase I-IV INC
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Central Miami Medical Institute (GMI)
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Suncoast Clinical Research, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Combined Research Orlando Phase I-IV
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Infinity Clinical Research - Sunrise
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Clinical Research of Brandon, LLC (Tampa)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Premier Research Institute at Palm Beach Neurology
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Charter Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Velocity Clinical Research, Boise
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Northwestern Medicine Central DuPage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Ascension Via Christi Research
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Neuro Medical Clinic of Central Louisiana, LLC
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Boston Neuro Research Center
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Clinical Research Professionals
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
CCT Research - Papillion Research Center
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Advanced Clinical Institute, Inc
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Albuquerque Neuroscience, Inc
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Dent Neurologic Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Parker Jewish Institute for Health Care & Rehabilitation
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040-1433
Country
United States
Facility Name
Mid Hudson Medical Research
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
NY Neurology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
University of Rochester Medical Center - Alzheimer's Disease Care, Research and Education Program
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Five Town Neuroscience Research
City
Woodmere
State/Province
New York
ZIP/Postal Code
11598
Country
United States
Facility Name
Triad Clinical Trials, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
Alzheimer's Memory Center
City
Matthew
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
Insight Clinical Trials LLC
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
NeuroScience Research Center, LLC
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Dayton Center for Neurological Disorders
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Summit Research Network, LLC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Brian Abaluck, LLC
City
Malvern
State/Province
Pennsylvania
ZIP/Postal Code
19355
Country
United States
Facility Name
Global Medical Institutes/Scranton Medical Institute - Moosic Division
City
Moosic
State/Province
Pennsylvania
ZIP/Postal Code
18507
Country
United States
Facility Name
Rhode Island Mood & Memory Research Institute
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Palmetto Clinical Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Senior Adults Specialty Research, Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Texas Neurology, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States
Facility Name
Baylor Scott & White Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Mt. Olympus Medical Research, LLC
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Grayline Research Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Green Mountain Research Institute, Inc.
City
Rutland
State/Province
Vermont
ZIP/Postal Code
05701
Country
United States
Facility Name
Re:Cognition Health
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Memory and Brain Wellness Center at Harborview
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
KaRa MINDS
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2113
Country
Australia
Facility Name
The University of Queensland
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Impact Health Pty Ltd.
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Eastern Health
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Delmont Private Hospital
City
Glen Iris
State/Province
Victoria
ZIP/Postal Code
3146
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Australian Alzheimer's Research Foundation
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
8009
Country
Australia
Facility Name
LMC Clinical Research - London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5R9
Country
Canada
Facility Name
Bluewater Clinical Research Group Inc
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Q & T Research
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1J 2G2
Country
Canada
Facility Name
Diex Research Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L0H8
Country
Canada
Facility Name
Alpha Recherche Clinique
City
Québec
ZIP/Postal Code
G3K 2P8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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