Nasal Protollin in Early Symptomatic Alzheimer's Disease

1. The Sponsor will rely on NIA-AA Alzheimer's Disease Diagnostic Guidelines1 for Early Symptomatic Alzheimer's Disease and have a MMSE of 29-20.

2. Age between 60-85 years (inclusive).

3. Good general health with no disease expected to interfere with the study.

4. On a stable medication regimen for 8 weeks prior to the study and which is anticipated to remain stable during the study.

5. Subject is not pregnant, lactating, or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile). ). If a woman is of childbearing potential, her partner is required to use contraception throughout the study (for those identifying as male).

6. Amyloid-positive PET scan (if subject meets all other inclusion criteria).

7. Ability to understand and provide informed consent

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)