Clinical Trial to Test the Efficacy and Safety of MMFS-205 in Early Alzheimer's Disease Patients

⁃ Patients meeting all of the following inclusion criteria should be considered for admission to the study:

• MMSE ≥ 19

• ≥ 55 and ≤ 85 years old at Screening

• Meet criteria for at least one of the following Stages of Early Alzheimer's Disease as defined below:

• Stage 3 AD (MCI due to AD)

‣ CDR Global score = 0.5, with

• 0.5 on memory box score; and

∙ 0.5 on at least one of the following functional measures: community affairs, home \& hobbies, or personal care

‣ MMSE ≥ 24

• Stage 4 AD (Mild AD):

‣ CDR Global score = 1, with

• 0.5 on memory box score; and

∙ 0.5 on at least one of the following functional measures: community affairs, home \& hobbies, or personal care; OR

‣ CDR Global score = 0.5, with

• 0.5 on memory box score; and

∙ 0.5 on at least one of the following functional measures: community affairs, home \& hobbies, or personal care; and MMSE 19-23

• ≥ 3 on at least one of the following Neuropsychiatric Inventory (NPI) behavioral areas: Agitation/Aggression, Depression/Dysphoria, Anxiety, Apathy/Indifference, Disinhibition, or Irritability/Lability, and total NPI score in these behavioral areas ≥ 6.

• Total Body weight (bw) must be ≥50 kg and ≤110 kg and lean body mass (LBM) must be ≤ 85 kg at screening

• Must be fluent in English

• Must have a friend/family member who frequently spends time with the subject (≥10 hours per week), and is willing to serve as an informant, and accompany the subject to, and participate in, all clinic visits

• Completion of at least 10 years of formal education (i.e., possess high school diploma, GED, or equivalent)

• Hearing and Vision ability sufficient to complete neurocognitive testing

⁃ Be able and willing to collect urine (at home) for 12 hours the day prior to follow up visits (optional for Stage 4 patients).