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Simufilam for Alzheimer's Disease (PTI-125 Trial)
Phase 2
Waitlist Available
Research Sponsored by Cassava Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12 to mont 18
Awards & highlights
Summary
This trial tests simufilam pills in patients with mild-to-moderate Alzheimer's disease. The treatment aims to improve memory and thinking by affecting certain brain proteins. The study will monitor safety and effectiveness over an extended period.
Who is the study for?
This trial is for adults aged 50-85 with mild-to-moderate Alzheimer's, living independently or in a setting without full-time nursing care. Participants must be non-smokers for at least 3 years, fluent in English or Spanish, and have certain cognitive scores. They should be generally healthy and not on specific high-dose medications. A caregiver must assist with medication administration.
What is being tested?
The study tests Simufilam (PTI-125) tablets taken twice daily by people who've had previous simufilam treatments or are newly diagnosed with Alzheimer's. After one year of treatment for all, there's a six-month period where half will switch to placebo randomly before another open-label phase.
What are the potential side effects?
While the trial primarily assesses safety over two years, potential side effects aren't detailed here but may include typical drug reactions such as gastrointestinal issues, allergic responses, changes in liver enzymes or blood counts based on its pharmacological class.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 12 to mont 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12 to mont 18
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog-11)
Change from baseline in ADAS-Cog-11 during open-label period 1
Change from baseline in CSF P-tau, Total Tau, Abeta42, neurofilament light chain, neurogranin, YKL-40, soluble TREM2 and HMGB1 during first 6 months of open-label period 1
+1 moreSecondary study objectives
Change from baseline in CSF P-tau, Total Tau, Abeta42, neurofilament light chain, neurogranin, YKL-40, soluble TREM2 and HMGB1 during open-label period 1
Change from baseline in plasma P-tau181 during open-label period 1
Change from baseline in plasma SavaDx during open-label period 1
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Simufilam 100 mg oral tablets throughoutExperimental Treatment1 Intervention
Simufilam 100 mg oral tablets administered twice daily (BID) for the full 24 months (including the randomized period Month 12 to Month 18)
Group II: Simufilam 100 mg oral tablets / Placebo / Simufilam 100 mg oral tabletsPlacebo Group2 Interventions
This placebo arm is only for Month 12 to Month 18. Day 1 to Month 12, as well as Month 18 to Month 24 are open-label treatment periods of simufilam 100 mg b.i.d. for all subjects.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Simufilam 100 mg oral tablet
2020
Completed Phase 2
~220
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors (e.g., donepezil, rivastigmine) and NMDA receptor antagonists (e.g., memantine). Cholinesterase inhibitors work by preventing the breakdown of acetylcholine, a neurotransmitter important for learning and memory, thereby improving communication between nerve cells.
Memantine regulates glutamate activity to prevent excitotoxicity, which can damage neurons. Simufilam, a newer treatment under study, stabilizes filamin A to reduce neuroinflammation and synaptic dysfunction, addressing underlying pathological processes in AD.
These mechanisms are crucial as they aim to alleviate cognitive symptoms and slow disease progression, improving the quality of life for AD patients.
A Risk-Benefit Assessment of Dementia Medications: Systematic Review of the Evidence.
A Risk-Benefit Assessment of Dementia Medications: Systematic Review of the Evidence.
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Who is running the clinical trial?
Cassava Sciences, Inc.Lead Sponsor
8 Previous Clinical Trials
3,653 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,783 Total Patients Enrolled
Lindsay Burns, PhDStudy ChairCassava Sciences
2 Previous Clinical Trials
77 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tested positive for HIV, Hepatitis C, or Hepatitis B.You have a medical condition that would make it difficult to perform a lumbar puncture.Your body mass index (BMI) is below 18.5.You have tested positive for drugs in your urine.You have had thoughts or actions related to suicide.Your diabetes is not well controlled, and you need high doses of insulin or metformin to manage it.If you have low thyroid levels, it must be treated and stable for at least 6 months before screening.Your kidneys are not working well, as shown by blood tests or estimated glomerular filtration rate (eGFR) below a certain level.You have had cancer, except for certain types, within the last 3 years.You have a history of a specific type of colon or intestinal condition called ischemic colitis or ischemic enterocolitis.You have had more than one heart attack in the 5 years before screening.You have a serious heart rhythm problem, weak heart muscle, or a problem with your heart's electrical system (unless you have a pacemaker).You have low blood pressure with symptoms, or your high blood pressure is not well controlled.Your heart's electrical activity, as shown in a test called ECG, is not within the normal range.You have developed dementia after experiencing a heart attack, undergoing surgery with general anesthesia, or being resuscitated.You have a diagnosis of certain brain diseases like Huntington's disease, Parkinson's disease, or others.You currently have a serious infection in your brain or spinal cord.You are currently taking a high dose of donepezil, or have taken a high dose within the past 3 months.You are currently taking medication to control seizures.You regularly take painkillers that contain opioids.Taking medications that make you sleepy.You have used nicotine patches, varenicline (Chantix), or similar medications to quit smoking in the past 30 days.You have been diagnosed with dementia caused by Alzheimer's disease.You have not smoked for at least 3 years.You must have a specific score on a memory test, or show evidence of Alzheimer's disease in a brain scan or spinal fluid test.You stopped taking a certain type of medication less than 30 days before joining the study.If you are taking certain types of antidepressants, you may not be able to participate. If you are taking other types of antidepressants, you must have been taking the same dose for at least 3 months before joining the study.You have had a brain tumor or any other significant growth in your brain.You have had COVID-19 within the past 3 months.You are between 50 and 85 years old.You have not smoked for at least 3 years.You are not taking strong medications that weaken your immune system, except for treating allergies or inflammation.You have lost a lot of blood (more than 450 mL) in the month before the study.You can take a small amount of antipsychotic medicine if it's for sleep, agitation, or aggression, and you've been taking the same amount for at least 3 months.Your liver enzymes (ALT or AST) or total bilirubin levels are too high, and it's a concern for the doctor leading the study or the organization sponsoring the study.You have Wernicke's encephalopathy.You are not taking certain medications for anxiety or sleep, unless it is a low dose of benzodiazepines or zolpidem for insomnia and you have been taking it consistently for at least 3 months before the study.You have a history of serious health problems with your brain, liver, kidneys, hormones, heart, stomach, lungs, or metabolism.You live in a nursing home and need care around the clock.Your recent lab tests show important health issues.If you are taking certain medications for memory and thinking problems, you need to have been on a stable dose for at least 3 months before the screening. If you are taking donepezil, it should be at a specific dose once daily. You can take more than one medication.You had a stroke or dementia within the past 18 months.You had a serious head injury with loss of consciousness in the past year or at the same time as when dementia started.If you're taking certain medications for memory problems, you need to have been on a stable dose for at least 3 months. If you're taking another specific medication, it needs to be at a certain dosage. You can take more than one medication.
Research Study Groups:
This trial has the following groups:- Group 1: Simufilam 100 mg oral tablets throughout
- Group 2: Simufilam 100 mg oral tablets / Placebo / Simufilam 100 mg oral tablets
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT04388254 — Phase 2
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