Clinical trial: PMZ-1620 (Sovateltide) in Mild to Moderate Alzheimer's Disease (NCT04052737)

Eligibility criteria:
Inclusion Criteria:

          1. Adult males or females Aged 45 years through 85 years (have not had their 86th
             birthday)

          2. Men and women with a diagnosis of Alzheimer's disease according to the clinical
             criteria

          3. Women must be of non-childbearing potential, surgically sterile, or willing to use
             adequate birth control; men who are sexually active will also be required to use
             adequate birth control

          4. Able to give consent for participation on their own or through their Legally
             Acceptable Representative

          5. MRI/CT scan assessment within six months before baseline, corroborating the clinical
             diagnosis of AD and excluding other potential causes of dementia, especially
             cerebrovascular lesions

          6. MMSE score in between 11 to 26 in case of mild to moderate stage of Alzheimer's
             disease

        6. Absence of major depressive disease according to Geriatric Depression Scale (GDS) of < 5
        7. Previous decline in cognition for more than six months as documented in subject's
        medical records 8. Subject, who are on stable treatment with any of AD drugs are also
        eligible to participate in this study 9. Formal education for eight or more years 10.
        Subjects living at home or nursing home setting, without continuous nursing care 11.
        General health status acceptable for participation in a 6-months clinical trial 12. A
        caregiver available and living in the same household or interacting with the subject a
        sufficient time each week and available if necessary to assure administration of drug 13.
        Subjects with any other chronic conditions are stable and undergoing appropriate treatment

        Exclusion Criteria:

          1. Subjects who have a Mini Mental State Examination (MMSE) score of < 10

          2. Subjects who have serious or unstable medical conditions that would exclude completion
             of all procedures and data collection for the study, or would be likely to preclude
             participation in a drug development trial

          3. A current Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis of
             active major depression, schizophrenia or bipolar disorder

          4. Other infectious, metabolic or systemic diseases affecting the central nervous system

          5. Subjects who have participated in a clinical trial investigating an anti-amyloid agent

          6. Subjects who are currently participating in a clinical trial with an investigational
             drug

          7. Subjects who, in the opinion of the physician, are otherwise unsuitable for this study

          8. Clinically significant, advanced or unstable disease that may interfere with outcome
             measures, and which may bias the assessment of the clinical or mental status of the
             subject or put the subject at special risk

          9. History of or screening brain MRI scan indicative of significant abnormality,
             including, but not limited to, prior hemorrhage or infarct > 1 cm3, >3 lacunar
             infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation,
             subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor
             such as meningioma)

         10. Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic
             attack or required intervention for any of these conditions within 6 months of
             Screening

         11. Clinical or laboratory findings consistent with:

               1. Other primary degenerative dementia,

               2. Other neurodegenerative condition

               3. Seizure disorder

         12. Subjects, who are already taking sedatives, antidepressants, antipsychotics and
             antihistaminic medications
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? Entailment