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Status:

COMPLETED

Simufilam (PTI-125), 100 mg, for Mild-to-moderate Alzheimer's Disease Patients

Lead Sponsor:

Cassava Sciences, Inc.

Collaborating Sponsors:

National Institute on Aging (NIA)

Conditions:

Alzheimer Disease

Eligibility:

All Genders

50-85 years

Phase:

PHASE2

Brief Summary

A two-year safety study of simufilam (PTI-125) 100 mg oral tablets twice daily for participants of the previous simufilam studies as wells as additional new mild-to-moderate Alzheimer's disease subjec...

Detailed Description

The objectives of this study are to build the safety database for simufilam (PTI-125) and to investigate its effects on biomarkers, cognition and neuropsychiatric symptoms during 12-month twice-daily ...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Informed consent form (ICF) signed by the subject or legally acceptable representative.
  • Patient has a caregiver or legal representative responsible for administering the drug and recording the time.
  • Ages ≥ 50 and ≤ 85 years
  • Clinical diagnosis of dementia due to possible or probable AD consistent with criteria established by a workgroup of the National Institute on Aging and the Alzheimer's Disease Association.
  • If female, postmenopausal for at least 1 year
  • Patient living at home, senior residential setting, or an institutional setting without the need for continuous (i.e. 24-h) nursing care
  • General health status acceptable for participation in the study
  • Fluency (oral and written) in English or Spanish
  • If receiving memantine, rivastigmine, galantamine or an AChEI, receiving a stable dose for at least 3 months (90 days) before screening. If receiving donepezil, receiving any dose lower than 23 mg once daily. Multiple medications are allowed.
  • The patient is a non-smoker for at least 3 years.
  • The patient or legal representative must agree to comply with the drawing of blood samples for the PK assessments, laboratory assessments and SavaDx.
  • MMSE-2 score ≥ 16 and ≤ 26 at screening, OR if \> 26, must have evidence of AD pathology such as a prior CSF total tau/Aβ42 ratio ≥ 0.28, an amyloid positive PET scan or hippocampal volume loss consistent with AD.
  • EXCLUSION CRITERIA:
  • Anything that in the opinion of the Investigator would preclude participation in a 2-year study.
  • BMI \< 18.5
  • Positive urine drug screen.
  • Positive HIV, HCV or HbsAg screen.
  • Suicidality on C-SSRS
  • Exposure to an experimental drug other than simufilam, experimental biologic or experimental medical device within 3 months before screening
  • A medical condition that would interfere with a lumbar puncture
  • Residence in a skilled nursing facility and requiring 24 h care.
  • Clinically significant laboratory test results
  • Clinically significant untreated hypothyroidism (if treated, thyroid-stimulating hormone level and thyroid supplementation dose must be stable for at least 6 months before screening)
  • Insufficiently controlled diabetes mellitus, including requiring insulin or metformin \>1000 mg/day.
  • Renal insufficiency (serum creatinine \> ULN and clinically significant in the opinion of PI and/or Sponsor OR eGFR \<60 ml/min/m2 as estimated by either the MDRD or CKD-EPI equation)
  • Malignant tumor within 3 years before screening (except squamous and basal cell carcinoma or cervical carcinoma in situ or localized prostate cancer or localized stage 1 bladder cancer)
  • History of ischemic colitis or ischemic enterocolitis
  • Unstable medical condition that is clinically significant in the judgment of the investigator
  • Alanine transaminase (ALT) or aspartate transaminase (AST) \> ULN or total bilirubin \> ULN and clinically significant in the opinion of PI and/or Sponsor.
  • History of myocardial infarction or unstable angina within 6 months before screening
  • History of more than 1 myocardial infarction within 5 years before screening
  • Clinically significant cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (patients with a pacemaker are acceptable)
  • Symptomatic hypotension, or uncontrolled hypertension
  • Clinically significant abnormality on screening electrocardiogram (ECG), including but not necessarily limited to a confirmed QTc (Fridericia correction method) value ≥ 450 msec for males or ≥ 470 msec for females.
  • Stroke within 18 months before screening, or history of a stroke concomitant with onset of dementia
  • History of brain tumor or other clinically significant space-occupying lesion on CT or MRI
  • Head trauma with clinically significant loss of consciousness within 12 months before screening or concurrent with the onset of dementia
  • Onset of dementia secondary to cardiac arrest, surgery with general anesthesia, or resuscitation
  • Specific degenerative CNS disease diagnosis other than AD (e.g., Huntington's disease, Creutzfeld-Jacob disease, Down's syndrome, Frontotemporal Dementia, Parkinson's disease)
  • Wernicke's encephalopathy
  • Active acute or chronic CNS infection
  • Donepezil 23 mg or greater QD currently or within 3 months prior to randomization
  • Discontinued AChEI \< 30 days prior to randomization
  • Antipsychotics; low doses are allowed only if given for sleep disturbances, agitation and/or aggression, and only if the subject has received a stable dose for at least 3 months before randomization
  • Tricyclic antidepressants and monoamine oxidase inhibitors; all other antidepressants are allowed only if the subject has received a stable dose for at least 3 months before randomization
  • Anxiolytics or sedative-hypnotics, including barbiturates (unless given in low doses for benign tremor); low doses of benzodiazepines and zolpidem are allowed only if given for insomnia/sleep disturbance, and only if the subject has received a stable dose for at least 3 months before randomization
  • Immunosuppressants, including systemic corticosteroids, if taken in clinically immunosuppressive doses (Steroid use for allergy or other inflammation is permitted.)
  • Antiepileptic medications if taken for control of seizures
  • Chronic intake of opioid-containing analgesics
  • Sedating H1 antihistamines
  • Nicotine therapy (all dosage forms including a patch), varenicline (Chantix), or similar therapeutic agent within 30 days before screening
  • Clinically significant illness within 30 days of enrollment
  • History of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease
  • Loss of a significant volume of blood (\> 450 mL) within 4 weeks prior to the study
  • COVID-19 infection within 3 months

Exclusion

    Key Trial Info

    Start Date :

    March 24 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 9 2023

    Estimated Enrollment :

    220 Patients enrolled

    Trial Details

    Trial ID

    NCT04388254

    Start Date

    March 24 2020

    End Date

    November 9 2023

    Last Update

    April 22 2025

    Active Locations (17)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 5 (17 locations)

    1

    Cognitive Clinical Trials

    Gilbert, Arizona, United States, 85296

    2

    Cognitive Clinical Trials

    Surprise, Arizona, United States, 85374

    3

    Sun Valley Research Center, Inc.

    Imperial, California, United States, 92251

    4

    Brain Matters Research

    Delray Beach, Florida, United States, 33445