Clinical trial: Safety of SNK01 in Subjects With Mild Cognitive Impairment (MCI) and Alzheimer's Disease (NCT04678453)

Eligibility criteria:
Inclusion Criteria:

          -  Capable of giving signed informed consent which includes compliance with the
             requirements and restrictions listed in the informed consent form and protocol. If the
             subject is incapable of giving or signing informed consent, the subject must have a
             legally authorized representative willing to consent on their behalf.

          -  Subject must be ≥ 55 to 85 years old at the time of consent.

          -  Magnetic resonance imaging (MRI) scans of the brain within the past six months reveal
             evidence and findings consistent with Alzheimer's disease, including hippocampal
             volume loss and/or overall cerebral atrophy (cerebral volume loss).

          -  Fluorodeoxyglucose-positron emission tomography (FDG-PET) scans of the brain within
             the past six months reveal evidence and findings consistent with mild cognitive
             impairment or Alzheimer's disease.

          -  Subject presenting, during evaluation by the study Investigator, to have spontaneous
             memory loss or presenting abnormal memory function in early screening.

          -  Subject must be in good health with adequate hearing and vision.

          -  Subject must have a reliable caregiver.

          -  Women of childbearing potential who are not abstinent and intend to be sexually active
             with a nonsterilized male partner must be willing to use an adequate method of
             contraception throughout the study and for one month following the last day of the
             last administration of final study drug dose. Acceptable methods include hormonal
             contraception (oral contraceptives [taken 90 days prior to administration of study
             drug], intrauterine devices (IUD), or double barrier methods (e.g., vaginal
             diaphragm/vaginal sponge plus condoms, or condom plus spermicidal jelly), sexual
             abstinence, or a vasectomized partner.

        Exclusion Criteria:

          -  Any medical or neurological conditions, other than Alzheimer's disease, that could
             contribute to the cause of cognitive impairment in the subject. Examples include, but
             are not limited to, frontotemporal dementia (FTD), Lewy body dementia, vascular
             dementia, Parkinson's disease, corticobasal degeneration, Creutzfeldt-Jakob disease,
             progressive supranuclear palsy, Huntington's disease, normal pressure hydrocephalus,
             seizure disorders or cerebral hypoxia, post-traumatic stress disorder (PTSD), or
             alcohol or medication use or abuse.

          -  Subject does not present with signs of mild cognitive impairment or Alzheimer's
             disease at screening, or during evaluation by the study Investigator.

          -  Subject presents with significant brain disease including hemorrhage or infarction.

          -  Subject has a history of cerebrovascular accident or transient ischemic attack (TIA),
             or unexplainable loss of consciousness during the past year.

          -  Subject has a history of schizophrenia, schizoaffective disorder, major depressive
             disorder (MDD), bipolar disorder, or any other clinically relevant psychiatric
             disease.

          -  Subject has a history of seizure episodes within the past three years.

          -  Subject has uncontrolled diabetes mellitus.

          -  Subject has a history of unstable angina, myocardial infarction, chronic heart
             failure, or clinically relevant conduction abnormalities within the year prior to
             screening.

          -  Subject suffers from renal or hepatic failure.

          -  Subject is infected with the human immunodeficiency virus (HIV), Hepatitis B (Hep B),
             Hepatitis C (Hep C), or any other infection or active systemic disease.

          -  Subject is using anticoagulants (except aspirin at or below a prophylactic dose).

          -  Subject is currently exceeding the normal recommended dosage for any drug used to
             treat Alzheimer's disease (e.g., memantine or acetylcholinesterase inhibitors
             [AChEI]).

          -  Subject has contraindication to MRI scans, FDG-PET scans, or lumbar spinal taps.

          -  Subject whose safety is considered to be at risk from trial's intervention, as
             determined by the study Investigator.

          -  Pregnant or lactating female subjects.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 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