Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease

Inclusion Criteria:

• Male or female aged 50 years or older, inclusive at the time of Screening.

• Clinical syndrome of mild or moderate dementia, likely to be due to AD in theopinion of the Investigator, at Screening, including meeting the following criteria:

1. Clinical Dementia Rating (CDR) global score of 0.5 to 1.0

2. Mini-mental state examination (MMSE) score of 18 to 26

3. Magnetic resonance imaging (MRI) or computerized tomography (CT) scan within 1year prior to randomization that excludes alternative diagnoses for dementiasuch as large stroke, likely vascular dementia, brain tumor, subdural hematoma,or other non-AD dementia type findings

4. Positive plasma AD biomarker signature at Pre-screening, comprising fastinglevels of a tau species protein.

• If receiving symptomatic AD medications, the dosing regimen must have been stablefor 3 months prior to Screening.

• Has a consenting trial partner who, in the Investigator's judgment, has frequent andsufficient contact with the participant to be able to provide accurate informationas to the participant's cognitive and functional abilities. The trial partner mustbe available to provide information to the Investigator and trial site staff aboutthe participant and agrees to attend all trial site visits in person for scalecompletion. A trial partner should be available for the duration of the trial. Themeasure of adequate availability will be at the Investigator's discretion.

• Participants must be able to comfortably abstain from caffeine intake for 4 hoursprior to scheduled cognitive assessments.

• Smokers are eligible if they are able to comfortably abstain from nicotine / tobaccoproducts for 2 hours prior to scheduled cognitive assessments.

• Must provide written informed consent to participate in the trial and be willing andable to participate for the maximum of 9 months of treatment and up to 11.5 monthsof site visits.

Exclusion Criteria:

• Use of anti-amyloid or anti-tau antibody within 6 months.

• Diagnosis of a non-AD dementia including traumatic brain injury.

• Diagnosis of an active major mental illness of concern in the opinion in theInvestigator, including major depressive disorder, bipolar illness, orschizophrenia.

• Participation in another clinical trial of a drug or device

• Has a body mass index or body weight that will interfere with participation in thetrial, including inadequate venous access to complete the trial assessments, to bedetermined at the discretion of the Investigator.

• Previous clinically significant systemic illness or infection, including testpositive COVID-19, within the past 4 weeks prior to Screening.

• Clinical diagnosis of Type I or Type II diabetes requiring insulin.

• Exhibit physical, cognitive, or language impairments, in the opinion of theInvestigator, of such severity as to adversely affect the validity of the dataderived from the neuropsychological tests.

• Trial participants with evidence of current infection with HIV, hepatitis B, orhepatitis C.

• Participants with a history of clinically significant drug abuse or addiction in thepast 2 years

• Evidence or history of alcohol abuse