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Open-label Extension for Phase 3 Clinical Trials of Simufilam

Primary Purpose

Alzheimer Disease

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Simufilam
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

51 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criterion:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Xenoscience, Inc.
  • Advanced Research Center, Inc.
  • Axiom Research, LLC
  • ATP Clinical Research, Inc.
  • Senior Clinical Trials
  • Artemis Institute for Clinical Research
  • Syrentis Clinical Research
  • Mountain Neurological Research Center
  • Colorado Neurological Research Center, PC
  • JEM Research Institute
  • Neurology Offices of South Florida
  • Clinical Research of Brandon, LLC
  • Neuropsychiatric Research Center of Southwest Florida
  • Velocity Clinical Research, Hallandale Beach
  • CNS Healthcare - Jacksonville
  • Charter Research
  • ClinCloud
  • South Florida Research Phase I-IV INC
  • Central Miami Medical Institute (GMI)
  • New Horizon Research Center
  • Suncoast Clinical Research, Inc.
  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
  • Medical Research
  • Clinical Research of Brandon, LLC (Tampa)
  • Stedman Clinical Trials
  • Premier Research Institute at Palm Beach Neurology
  • Charter Research
  • Columbus Memory Center, PC
  • 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
  • The Cognitive and Research Center of New Jersey (CRCNJ)
  • Albuquerque Neuroscience, Inc
  • Neurological Associates of Albany
  • Dent Neurologic Institute
  • Velocity Clinical Research, Formerly Clarity Clinical Research
  • 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
  • Alzheimer's Memory Center
  • Insight Clinical Trials LLC
  • NeuroScience Research Center, LLC
  • Dayton Center for Neurological Disorders
  • Summit Research Network, LLC
  • Keystone Clinical Studies, LLC
  • Rhode Island Mood & Memory Research Institute
  • Senior Adults Specialty Research, Inc
  • Texas Neurology, PA
  • Grayline Research Center
  • Re:Cognition Health
  • Northwest Clinical Research Center
  • Memory and Brain Wellness Center at Harborview
  • Alpha Recherche Clinique

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Simufilam 100 mg

Arm Description

simufilam 100 mg oral tablet, twice daily

Outcomes

Primary Outcome Measures

Adverse event monitoring
Adverse event monitoring

Secondary Outcome Measures

Full Information

First Posted
October 7, 2022
Last Updated
September 13, 2023
Sponsor
Cassava Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05575076
Brief Title
Open-label Extension for Phase 3 Clinical Trials of Simufilam
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
July 15, 2026 (Anticipated)
Study Completion Date
July 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cassava Sciences, Inc.

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
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.
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).

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
Single Group Assignment
Model Description
Open-label extension
Masking
None (Open Label)
Allocation
N/A
Enrollment
1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simufilam 100 mg
Arm Type
Experimental
Arm Description
simufilam 100 mg oral tablet, twice daily
Intervention Type
Drug
Intervention Name(s)
Simufilam
Other Intervention Name(s)
PTI-125
Intervention Description
simufilam 100 mg oral tablet, twice daily
Primary Outcome Measure Information:
Title
Adverse event monitoring
Description
Adverse event monitoring
Time Frame
Baseline to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
51 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criterion: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Kupiec, MD
Organizational Affiliation
Cassava Sciences, Inc.
Official's Role
Study Director
Facility Information:
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
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
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
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
Clinical Research of Brandon, LLC
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
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
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
32792
Country
United States
Facility Name
ClinCloud
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
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
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
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
Columbus Memory Center, PC
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
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
The Cognitive and Research Center of New Jersey (CRCNJ)
City
Springfield
State/Province
New Jersey
ZIP/Postal Code
07081
Country
United States
Facility Name
Albuquerque Neuroscience, Inc
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Neurological Associates of Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Dent Neurologic Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
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
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
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
Keystone Clinical Studies, LLC
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
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
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
Grayline Research Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Re:Cognition Health
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
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
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

Open-label Extension for Phase 3 Clinical Trials of Simufilam

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