Effect of CT1812 Treatment on Brain Synaptic Density

Inclusion Criteria

• Participants may be included in the study only if they meet all of the following criteria:
• Men, and women of non-childbearing potential, 50-85 years of age inclusively, with a diagnosis of mild to moderate Alzheimer's disease according to the 2011 NIA-AA criteria and at least a 6 month decline in cognitive function documented in the medical record.
• Non-childbearing potential for women is defined as postmenopausal [last natural menses greater than 24 months; in women under age 55, menopausal status will be documented with serum follicle stimulating hormone (FSH) test] or undergone a documented bilateral tubal ligation or hysterectomy.
• Male participants who are sexually active with a woman of child-bearing potential must agree to use condoms during the trial and for 3 months after last dose unless the woman is using an acceptable means of birth control. Acceptable forms of birth control include abstinence, birth control pills, or any double combination of: intrauterine device (IUD), male or female condom, diaphragm, sponge, and cervical cap.
• Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease and without findings of significant exclusionary abnormalities (see exclusion criteria, number 3).
• MMSE 18-26 inclusive
• A positive amyloid (Pittsburgh imaging compound B) scan at screening, or history of a positive amyloid scan prior to study entry, or prior lumbar puncture with a CSF Abeta concentration consistent with Alzheimer's disease.
• Formal education of eight or more years.
• Must have a caregiver who sees them at least 10 hours per week, oversees the administration of study drug, and is willing and able to oversee administration of study medication and participate in all clinic visits and some study assessments. The caregiver must provide written informed consent to participate in the study.
• Living at home or in the community (assisted living acceptable)
• Able to swallow CT1812 capsules.
• Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening.
• Capable of providing either written informed consent or oral assent to the study procedures and for use of protected health information [Health Insurance Portability and Accountability Act (HIPAA) Authorization, if applicable]. If the Participant can provide only assent, their legally authorized representative also must provide written informed consent. Written informed consent also shall be obtained from the responsible caregiver. All consent processes must be undertaken in the presence of a witness and prior to any study procedures.
• Must consent to apolipoprotein E (ApoE) genotyping.
• Generally healthy with mobility (ambulatory or ambulatory-aided, i.e., walker or cane), vision and hearing (hearing aid permissible) sufficient for compliance with testing procedures.
• Able to complete all screening evaluations.

Exclusion Criteria

• Participants will be excluded from the study if any of the following conditions apply:
• Hospitalization or change of chronic concomitant medication within one month prior to screening.
• Patients living in a continuous care nursing facility
• Screening MRI of the brain indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct > 1 cm3, >3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma).
• MRI incompatible implants and other contraindications for MRI, such as pacemaker, artificial joints, non-removable body piercings, etc. Additionally, participants who meet the following imaging exclusion criteria will not be included in this study:
• Claustrophobia that will result in significant anxiety and difficulty lying still for brain imaging (MRI or PET).
• Participation in other research studies involving ioni