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PTI-125 for Older Adults With Mild to Moderate Alzheimer's Disease

Recruiting

This Phase 2 study will test the safety and efficacy of the experimental drug PTI-125 for the treatment of Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 85 Years All No
March 16, 2020
September 30, 2021
100

  • Caregiver or legal representative who can administer the drug and record the time
  • Diagnosis of dementia due to possible or probable Alzheimer's disease
  • Postmenopausal for at least 1 year
  • Living at home, in a senior residential facility, or an institutional facility, but cannot need 24-hour nursing care
  • Fluent in writing and speaking either English or Spanish
  • If taking memantine or an acetylcholinesterase inhibitor (rivastigmine, galantamine, or donepezil), dose must be stable for at least three months
  • If taking donepezil, does must be lower than 23 mg once daily
  • Nonsmoker for at least three years
  • Must agree to have blood samples drawn and to complete laboratory assessments, including a lumbar puncture for cerebrospinal fluid samples (CSF). Ratio of total tau/A42 in CSF 0.28
  • Mini-Mental State Exam score of 16-26; if over 26, must show study results of Alzheimer's diagnosis, such as an amyloid-positive PET scan

  • Positive urine drug test at screening
  • Positive HIV, hepatitis C, or hepatitis B screen
  • Risk for suicide
  • Exposure to an experimental drug other than PTI-125, experimental biologic, or experimental medical device within the longer of five half-lives or three months before screening
  • A medical condition that would interfere with a lumbar puncture
  • Clinically significant laboratory test results or unstable medical condition
  • Clinically significant untreated hypothyroidism
  • Poorly controlled diabetes
  • Renal insufficiency
  • Malignant tumor in past three years, except for squamous and basal cell cancer, cervical cancer, localized prostate cancer, or localized stage 1 bladder cancer
  • History of ischemic colitis or ischemic enterocolitis
  • Abnormal liver function tests
  • History of heart attack or unstable angina within past six months
  • History of more than one heart attack within past five years
  • Cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (participants with a pacemaker are OK)
  • Symptoms of low blood pressure or uncontrolled high blood pressure
  • Abnormal screening electrocardiogram
  • Stroke in past 18 months or history of a stroke that resulted in the onset of dementia
  • History of brain tumor or other brain lesion on CT or MRI
  • Head trauma with loss of consciousness in past year or head injury that resulted in the onset of dementia
  • Onset of dementia after cardiac arrest, surgery with general anesthesia, or resuscitation
  • Degenerative central nervous system disease diagnosis other than Alzheimer's disease, for example: Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, frontotemporal dementia, Parkinson's disease
  • Wernicke's encephalopathy
  • Active acute or chronic central nervous system infection
  • Prohibited medications: antipsychotics (low doses are allowed if given for sleep disturbances or agitation and/or aggression, and if on stable dose for at least three months); tricyclic antidepressants and monoamine oxidase inhibitors (other antidepressants are allowed if on a stable dose for at least three months); anxiolytics or sedative-hypnotics, including barbiturates unless given in low doses for benign tremor (low doses of benzodiazepines and zolpidem are allowed if given for insomnia/sleep disturbance on stable dose for at least three months); immunosuppressants, including systemic corticosteroids (steroid use for allergy or other inflammation is allowed); antiepileptic medications; chronic use of opioid-containing analgesics; sedating H1 antihistamine; nicotine therapy, varenicline (Chantix), or similar therapeutic agent within 30 days before screening
  • Clinically large amount of blood loss (>450 mL) within four weeks prior to joining the study
  • COVID-19 infection
  • Significant illness within 30 days of joining the trial
  • History of significant neurological, liver, kidney, endocrine, cardiovascular, gastrointestinal, lung, or metabolic disease

PTI-125 is a small-molecule drug being investigated for its potential to interact with a scaffolding protein in the brain, filamin A, that has been associated with Alzheimer's disease processes. Participants will take a 100 mg tablet of the study drug twice daily for one year. In addition to monitoring safety, researchers are investigating the effect of the medication on biomarkers, cognition, and neuropsychiatric symptoms.

Name City State Zip Status Primary Contact
Cognitive Clinical Trials
Gilbert Arizona 85296 Recruiting Niki Rathbun
480-653-8212
nikirathbun@cctresearch.com
Cognitive Clinical Trials
Surprise Arizona 85374 Recruiting George Thomas
480-530-2093
georgethomas@cctresearch.com
Optimus U
Miami Florida 33125 Recruiting Lainet Infante
305-702-0024
infante@optimusu.com
IMIC, Inc.
Palmetto Bay Florida 33157 Recruiting Minela Sulijicic-Martinez
786-310-7477
minela@aktamedika.com
Cognitive Clinical Trials
Bellevue Nebraska 68005 Recruiting Heather Diederich
402-509-2920
heatherdiederich@cctresearch.com
Cognitive Clinical Trials
Omaha Nebraska 68130 Recruiting Colleen Caliri
402-315-9218
colleencaliri@cctresearch.com
Advanced Memory Research Institute
Toms River New Jersey 08755 Recruiting Julia Carey
732-341-9500
jcarey@amrinj.com
Centex Studies, Inc.
Houston Texas 77058 Recruiting Shruti Konda
281-282-0808
skonda@centexstudies.com
Centex Studies
McAllen Texas 78504 Recruiting Joanna Gurrola
346-801-3326
joannagurrola@centexstudies.com

Cassava Sciences, Inc.

  • National Institute on Aging (NIA)

Name Role Affiliation
Lindsay Burns, PhD Study Chair Cassava Sciences

Name Phone Email
Lindsay Burns, PhD 512-501-2484 lburns@cassavasciences.com
Carrie Crowley, BA 512-501-2453 ccrowley@cassavasciences.com

NCT04388254

A 12-Month, Open-Label Safety Study of PTI-125 in Mild-to-moderate Alzheimer's Disease Patients