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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04388254
Recruitment Status : Recruiting
First Posted : May 14, 2020
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Cassava Sciences, Inc.

Brief Summary:
An Open-label study for patients who completed the previous studies, PTI-125-02 or PTI-125-03. Additional new patients will be included for a total of 100 patients enrolled for this study.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: PTI-125, 100 mg tablet Phase 2

Detailed Description:
The objectives of this study are to establish 1-year safety and to investigate the effect of PTI-125 on biomarkers, cognition and neuropsychiatric symptoms during 12-month repeat-dose oral administration in mild-to-moderate AD patients, 50-85 years of age.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Approximately one hundred (100) patients will be enrolled into the study. The patients will receive PTI-125, 100 mg b.i.d.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 12-Month, Open-Label Safety Study of PTI-125 in Mild-to-moderate Alzheimer's Disease Patients
Actual Study Start Date : March 16, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PTi-125, 100 mg tablets
PTI-125, 100 mg oral tablets administered twice daily (BID)
Drug: PTI-125, 100 mg tablet
PTI-125 100 mg oral tablet
Other Name: PTI-125




Primary Outcome Measures :
  1. Cerebrospinal fluid P-tau, neurofilament light chain, neurogranin, Total Tau, YKL-40, Abeta42 (pg/mL) [ Time Frame: Screening to Month 12 ]
    Biomarkers of AD pathology, neurodegeneration and neuroinflammation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent form (ICF) signed by the subject or legally acceptable representative.
  • Patient has a caregiver or legal respresentative responsible for administering the drug and recording the time.
  • Ages >= 50 and <= 85 years (upper limit waived for prior PTI-125 study participants)
  • Clinical diagnosis of dementia due to possible or probable Alzheimer's disease
  • 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. If receiving donepezil, 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, laboratory assessments and for new patients or patients starting < 30 days form the last PTI-125 study, with a lumbar puncture and the drawing of cerebrospinal fluid samples for biomarker assessments.

Additional Criteria for NEW patients:

  • The patient has a ratio of total tau/Aβ42 in cerebrospinal fluid >= 0.28.
  • MMSE score >= 16 and <=26 at screening, OR if > 26, must have evidence of AD pathology such as a prior CSF total tau/AB42 ratio >=0.28, an amyloid positive PET scan or hippocampal volume loss consistent with AD.

Exclusion Criteria:

  • Anything in the opinion of the Investigator would preclude participation in a 1-year study.
  • Positive urine drug test at screening
  • Positive HIV, HCV or HbsAg screen
  • Suicidality on C-SSRS
  • Exposure to an experimental drug other than PTI-125, experimental biologic or experimental medical device within the longer of 5 half-lives or 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
  • Insufficiently controlled diabetes mellitus
  • Renal insufficiency (serum creatinine > ULN and clinically signigicant in the opinion of PI and/or Sponsor)
  • 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 corrected QT interval 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 Central Nervous System disease diagnosis other than Alzheimer's disease (eg, Huntington's disease, Creutzfeld-Jacob disease, Down's syndrome, Frontotemporal Dementia, Parkinson's disease)
  • Wernicke's encephalopathy
  • Active acute or chronic Central Nervous System 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04388254


Contacts
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Contact: Lindsay Burns, PhD 512-501-2484 lburns@cassavasciences.com
Contact: Carrie Crowley, BA 512-501-2453 ccrowley@cassavasciences.com

Locations
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United States, Arizona
Cognitive Clinical Trials Recruiting
Gilbert, Arizona, United States, 85296
Contact: Niki Rathbun    480-653-8212    nikirathbun@cctresearch.com   
Principal Investigator: Brian Beck, MD         
Cognitive Clinical Trials Recruiting
Surprise, Arizona, United States, 85374
Contact: George Thomas    480-530-2093    georgethomas@cctresearch.com   
Principal Investigator: Patrick Sciara, MD         
United States, Florida
Optimus U Recruiting
Miami, Florida, United States, 33125
Contact: Lainet Infante    305-702-0024    infante@optimusu.com   
Contact: Klemnys Romero    305-702-0024    romero@optimusu.com   
Principal Investigator: Yaneicy Gonzalez-Rojas, MD         
IMIC, Inc. Recruiting
Palmetto Bay, Florida, United States, 33157
Contact: Minela Sulijicic-Martinez    786-310-7477    minela@aktamedika.com   
Principal Investigator: Evelyn Lopez-Brignoni, MD         
United States, Nebraska
Cognitive Clinical Trials Recruiting
Bellevue, Nebraska, United States, 68005
Contact: Heather Diederich    402-509-2920    heatherdiederich@cctresearch.com   
Contact: Colleen Caliri    402-315-9218    colleencaliri@cctresearch.com   
Principal Investigator: John Puente, MD         
Cognitive Clinical Trials Recruiting
Omaha, Nebraska, United States, 68130
Contact: Colleen Caliri    402-315-9218    colleencaliri@cctresearch.com   
Contact: Heather Diederich    402-509-2920    heatherdiederich@cctresearch.com   
Principal Investigator: Tamara A Doehner, MD         
United States, New Jersey
Advanced Memory Research Institute Recruiting
Toms River, New Jersey, United States, 08755
Contact: Julia Carey    732-341-9500    jcarey@amrinj.com   
Contact: Lauren Bawriec    732-341-9500      
Principal Investigator: Sanjiv Sharma, MD         
United States, Texas
Centex Studies, Inc. Recruiting
Houston, Texas, United States, 77058
Contact: Shruti Konda    281-282-0808    skonda@centexstudies.com   
Contact: Tara Green    281-282-0808    tgreen@centexstudies.com   
Principal Investigator: Joe E Pouzar, Jr., MD         
Centex Studies Recruiting
McAllen, Texas, United States, 78504
Contact: Joanna Gurrola    346-801-3326    joannagurrola@centexstudies.com   
Principal Investigator: Joel Solis, MD         
Sponsors and Collaborators
Cassava Sciences, Inc.
National Institute on Aging (NIA)
Investigators
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Study Chair: Lindsay Burns, PhD Cassava Sciences
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Responsible Party: Cassava Sciences, Inc.
ClinicalTrials.gov Identifier: NCT04388254    
Other Study ID Numbers: PTI-125-04
R44AG065152 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders