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

  • STATUS
    Recruiting
  • sponsor
    Cassava Sciences, Inc.
Updated on 25 March 2022

Summary

Simufilam is an experimental treatment, meaning that it has not yet been approved by the United States (US) Food and Drug Administration (FDA). In this study, the study medicine will be compared to a placebo. A placebo is a pill that looks exactly like the study medicine but does not contain any active ingredient.

In this study, you will take either simufilam 100 mg or placebo twice a day. Whether you receive simufilam 100 mg or placebo will be decided randomly (by chance, like flipping a coin). In this study, 1 out of every 2 participants (50%) will receive simufilam 100 mg twice a day and 1 out of every 2 participants (50%) will receive placebo twice a day. 

To make this study fair, you and the study doctor will not be told which medicine you will receive. This is called “blinding.” In case of an emergency, the study doctor will be able to look up which medicine you are taking at any time.

Description

About 750 people will be in this study from multiple countries. Your participation in this study is expected to last up to 62 weeks (or 14 months), including a follow-up check, if necessary. After your third visit at Week 4, your next visits will be scheduled about 12 weeks apart. You will begin treatment within 60 days (or 8 weeks) of the Screening Visit. Extra visits may be needed if your study doctor feels it is best for you.

This study is divided into 3 periods:
  • A Screening Period (up to 8 weeks): You will visit the study center at least 1 time during the Screening Period, but you may have additional visits if all screening procedures cannot be done in a single visit. During this period, the study doctor will explain to you everything about this study and answer any questions you have. If you decide you would like to take part in this study, the study doctor will ask you to sign the Participant Informed Consent Form. Then, certain tests and procedures will be done to find out if you are eligible to take part in this study. Your study doctor will review your answers and the results of the tests and will tell you whether or not you can be in this study. If you are not eligible at first because of certain criteria, you may be able to repeat screening, depending on the decision of your study doctor and Cassava.
  • A Treatment Period (of 52 weeks): At the end of the Screening Period, the study doctor will review your tests and procedures again and let you know if you are still eligible to take part in this study. If you are still eligible, the blinded Treatment Period will begin. During this time, you will make 6 visits to the study center in the morning. You will take your first dose on Study Day 1 at the study center, after certain procedures are completed. You will swallow the study drug (either simufilam 100 mg or placebo) at least 1 hour before you leave the study center on Study Day 1. You will swallow 1 more study drug pill at home later that day in the late afternoon or early evening, with or without food. You will be given a plastic bottle to take home with enough drug to last until your next visit. A refill of the study drug will be given each time you return to the study center for the next 4 visits. You will continue taking the study drug (by swallowing) twice a day at home for 52 weeks until the study is over. You must store the study drug as instructed (at room temperature and away from moisture). You will be asked to bring your study drug bottle to each visit to let the study staff check how many pills you have taken since the last visit.
  • During the Screening and Treatment Periods, a small group of participants will also take part in an optional sub-study called the pharmacokinetics (PK) and plasma biomarker sub-study. This sub-study will involve taking additional blood samples from you, some at set intervals after you take study drug, to see how the study drug is absorbed, distributed, and eliminated, and to see how it works in the body. Taking part in this sub-study is entirely voluntary. If you do not consent to participate in the sub-study, the decision will not affect your taking part in the main study. If you agree to participate in this optional sub-study, please tick the box marked “Yes” at the end of the Informed Consent Form.
  • After the Treatment Period, you will either:
    • Enter a Safety Follow-up Period (about 1 to 2 weeks): you and/or your study partner will receive a telephone call 1 to 2 weeks after taking the last dose of the study drug to check how you are doing. If necessary, you will make 1 more visit to the study center. You will not take any study drug during this period. OR
    • Be asked to take part in another study (the “extension” study) where all participants will take simufilam: If you decide to take part in that study, you will not have a telephone call or be asked to complete a Safety Follow-up Visit after taking the last dose of the study drug.

Details
Condition Alzheimer's Disease
Clinical Study IdentifierTX291195
SponsorCassava Sciences, Inc.
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 50- 87 (inclusive)
Gradual and progressive change in memory over the past 6 months
On stable medications for 12 weeks prior to screening
Must not be a smoker or user of chewed tobacco for at least 3 years
Must have a study partner who has at least 10 hours of contact with patient per week and is willing to accompany the patient to all study visits

Exclusion Criteria

Patients in skilled nursing facility requiring 24 hour care
Patients with a pacemaker
BMI less than 18.5 or greater than 35.0
Presence of other conditions that may contribute to memory loss
Patients with severe depression or suicidal ideations
History of TIA or stroke within 12 months or concurrent with the onset of dementia
History of seizure within 12 months
History of severe head trauma within 12 months or concurrent with the onset of dementia
Uncontrolled diabetes
Cancer within 3 years, except definitively treated squamous or basal cell carcinoma, cervical cancer in situ, localized non-progressive prostate cancer, or localized stage 1 bladder cancer, or colon polyp removed by excision
Known HIV+ or Hepatitis
Currently using substances of abuse
Thyroid disorders requiring treatment less than 3 months
Major cardiovascular event within the past 12 months
Donepezil (Aricept) greater than 10 mg within the past 3 months
COVID-19 infection within 3 months (Patients with no previous infection must be fully vaccinated)
Other medication and medical condition restrictions- discuss with the study team
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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