Testing SNK01 against a placebo for moderate alzheimer disease

Exclusion

• −Immunological disorder such as per investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → judgement clinically significant allergies, Lupus erythematodes, or scleroderma.
• −Significant liver disease (for example cirrhosis, active hepatitis B and C, primary or metastatic liver neoplasm).
• −Infection with human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or any other infection or active systemic disease.
• −Substantial concomitant cerebrovascular disease defined as Fazekas Grade 3.
• −History of a stroke/intracranial hemorrhage temporally related to the onset of worsening of cognitive impairment in the opinion of the investigator.
• −Any substance use disorder that has not been in remission for at least 12 months
• −Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
• −Uncontrolled cardiovascular illnesses such as chronic congestive heart failure (with or without oedema), tachycardia, arrhythmias, uncontrolled hypertension.
• −History of cerebrovascular accident or transient ischemic attack (TIA), or unexplainable loss of consciousness within the last year.
• −Significant pulmonary disease predisposing to hypoxia.
• −Significant ischemic heart disease, myocardial infarction within the last two years and/or with residual angina, orthopnea, conduction defects (ECG), or any other clinically significant heart disease classified as NYHA III or IV.
• −Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
• −Significant gastrointestinal disorders (for example gastrointestinal bleeding within the last two years, malabsorption syndromes, post-gastrectomy, or active peptic ulcer disease).
• −Uncontrolled/Unstable hematological disease (regardless of cause) such as refractory anemia or refractory myelosuppression.
• −Neurological disease (such as: Lewy body dementia - primary diagnosis, Huntington's disease, Parkinson's Disease, encephalitis, epilepsy, vascular or multi-infarct dementia, stroke, congenital mental deficiency, multiple sclerosis) and psychiatric disorders (such as schizophrenia, or intellectual disability), or any other disorders impacting cognitive function.
• −Unstable/uncontrolled major depression or anxiety within the last 12 months.
• −History of seizures in the past three years.
• −Uncontrolled endocrine disease such as uncontrolled diabetes mellitus or manifest hyperthyroidism, in the opinion of the investigator.
• −Severe renal impairment defined as a GFR \< 30 mL/min/1.73 m2 in the screening lab report
• −Currently being treated with anticoagulants (except aspirin at or below a prophylactic dose).
• −Participants who are taking medications for AD, like memantine or acetylcholinesterase inhibitors (AChEI) that exceeds the normal recommended dose range or have not achieved a stable dose for the 30 days prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
• −Any contraindication for performing a brain MRI and/or Amyloid PET scan.
• −Any participant whose safety the investigator considers to be at risk from this trial's intervention.
• −Participants with any medically unstable/uncontrolled conditions.
• −Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
• −Any suicidal ideation of type 4 or 5 in the C-SSRS in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).