Status:
COMPLETED
PTI-125 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
This is a Phase 2b, Randomized, Double-blind, Placebo-controlled, multiple dose study of PTI-125 in mild-to-moderate Alzheimer's disease patients.
Detailed Description
This is a Phase 2b, Randomized, Double-blind, Placebo-controlled, multiple dose study of PTI-125 in mild-to-moderate Alzheimer's disease patients. A total of sixty (60) patients will be enrolled in th...
Eligibility Criteria
Inclusion
- Ages \>= 50 and \<= 85 years
- Informed consent form (ICF) signed by the subject or legally acceptable representative.
- Clinical diagnosis of dementia due to possible or probable Alzheimer's disease
- Mini-Mental State Examination score \>= 16 and \<= 26 at screening
- 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.
- 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 and with a lumbar puncture and the drawing of cerebrospinal fluid samples.
- The patient has a ratio of total tau/Aβ42 in cerebrospinal fluid \>= 0.28.
- Patient has a caregiver or legal representative responsible for administering the drug and recording the time.
Exclusion
- Exposure to an experimental drug, experimental biologic or experimental medical device within the longer of 5 half-lives or 3 months before screening
- Enrollment in the previous PTI-125 trial
- 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)
- 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.
- 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 quaque die currently or within 3 months prior to randomization
- Discontinued AChEI \< 30 days prior to randomization
- Antipsychotics; low doses are allowed only if the subject has received a stable dose for at least 3 months before randomization
- Tricyclic antidepressants and monoamine oxidase inhibitors
- Anxiolytics or sedative-hypnotics, including barbiturates (unless given in low doses for benign tremor); low doses of benzodiazepines and zolpidem are allowed
- 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
- Positive serum hepatitis B surface antigen (HBsAg) or positive hepatitis C virus HCV antibody test at screening
- Positive HIV test at screening
- Positive urine drug test at screening
- Loss of a significant volume of blood (\> 450 mL) within 4 weeks prior to the study
- Suicidality on C-SSRS at screening
Key Trial Info
Start Date :
September 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04079803
Start Date
September 9 2019
End Date
March 31 2020
Last Update
September 29 2021
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