Nasal Protollin in Early Symptomatic Alzheimer's Disease

Exclusion Criteria

• •1. Any significant neurologic disease including Parkinson's disease, multi-infarct dementia, Huntington's disease, frontotemporal dementia, Lewy body dementia, normal pressure hydrocephalus, brain tumor, brain hemorrhage with persistent neurologic deficits, progressive supra-nuclear palsy, seizure disorder, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
• •2. Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease.
• •3. History of autoimmune disease.
• •4. Current treatment with immunomodulatory or immunosuppressive drugs, or corticosteroid administration by any route of administration (including nasal corticosteroids) within the past month.
• •5. Major depression or bipolar disorder or a history of schizophrenia.
• •6. History of alcohol or substance abuse or dependence within the past 2 years.
• •7. History within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment.
• •8. Clinically significant abnormalities (defined as greater than mild on the FDA's vaccine toxicity scale) in screening laboratories.
• •9. Participation in another clinical trial of an investigational drug concurrently or within the past 30 days.
• •10. Active COVID-19 disease
• •11. Amyloid-negative PET scan (at screening)
• •12. COVID-19 vaccine within past 10 days or any other vaccine within past 7 days (at dosing)