A Phase 2, Randomized, Prospective Double-Blind, Single-Center, Placebo-controlled Study to Evaluate Safety, Tolerability, Target Engagement, and Efficacy of PrimeC in Patients With Mild to Moderate Alzheimer's Disease (AD)
20 subjects with mild to moderate AD will be enrolled in the study and randomized at a 1:1 ratio to receive the study drug or placebo tablets, respectively. All subjects will be administered the drug/placebo twice daily (BID), two tablets each time, for 52 weeks. Subjects will be allowed to receive standard of care (SOC) treatment of approved products or their combination. Subjects will be evaluated every 3 months for safety and tolerability.
• Able to comprehend and willing to sign an informed consent form (ICF) and their ability to consent was estimated by an independent Neurologist or Geriatrist.
• Males or females between the ages of 55 and 85 years of age, inclusive
• Diagnosis of probable AD with evidence of the AD pathophysiological process according to the diagnostic criteria of the National Institute on Aging and Alzheimer's Association
• AD patients with a score of 18 to 24 on MMSE at screening.
• Subjects may be treated in parallel with rivastigmine, donepezil, galantamine, memantine, donezepil, aducanumab, and lecanemab or their combination. For rivastigmine, donepezil, galantamine, memantine, donezepil - 30 days of stable use prior to enrollment is required. For aducanumab and lecanemab - 3 months of stable use prior to enrollment is required.
• 18 \< BMI \< 30
• Patients who have a caregiver - the caregiver shall be in contact with the patient at least 10 hours per week, and can attend all visits with the patient, report on the subject's status and verify compliance with all study requirements.
• CT or MRI available within 12 months before the enrolment to the study devoid of any structural finding which could explain the cognitive impairment, except for brain atrophy or white matter hyperintensities which can be observed in AD patients.
• CT or MRI available within 3 months before the lumbar puncture.
⁃ Presence of pTau 181 in CSF at screening
⁃ Female with no childbearing potential (at least 1 year postmenopausal or surgical contraception)