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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05575076




Registration number
NCT05575076
Ethics application status
Date submitted
7/10/2022
Date registered
12/10/2022
Date last updated
9/10/2024

Titles & IDs
Public title
Open-label Extension for Phase 3 Clinical Trials of Simufilam
Scientific 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
Secondary ID [1] 0 0
PTI-125-10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Simufilam

Experimental: Simufilam 100 mg - simufilam 100 mg oral tablet, twice daily


Treatment: Drugs: Simufilam
simufilam 100 mg oral tablet, twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse event monitoring
Timepoint [1] 0 0
Baseline to 52 weeks

Eligibility
Key inclusion 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.
Minimum age
51 Years
Maximum age
89 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/07/2026
Actual
Sample size
Target
1600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
KaRa Institute of Neurological Diseases Pty. Ltd. - Macquarie Park
Recruitment hospital [2] 0 0
The University of Queensland - Herston
Recruitment hospital [3] 0 0
Delmont Consulting Suites - Glen Iris
Recruitment hospital [4] 0 0
Austin Health - Heidelberg
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
Eastern Health - Melbourne
Recruitment hospital [7] 0 0
Alzheimer's Research Australia - Nedlands
Recruitment postcode(s) [1] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3146 - Glen Iris
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
3128 - Melbourne
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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Georgia
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United States of America
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Idaho
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Illinois
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United States of America
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Kansas
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Kentucky
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Louisiana
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Massachusetts
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Missouri
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Nebraska
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Texas
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Virginia
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Washington
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Canada
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British Columbia
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Canada
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New Brunswick
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Korea, Republic of
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Buk-gu
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Korea, Republic of
State/province [33] 0 0
Dong-gu
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Incheon
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Korea, Republic of
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Jung-gu
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Puerto Rico
State/province [37] 0 0
Bayamón
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Puerto Rico
State/province [38] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cassava Sciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05575076
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jim Kupiec, MD
Address 0 0
Cassava Sciences, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05575076