Dementia Clinical Trials

• Participant and/or Caregiver must provide a signed and dated ICF prior to any study procedures.

• Must have a Caregiver who is able and willing to comply with all required study procedures.

• The Caregiver must be known to the Participant and must be able to use electronic devices such as a cell phone, video conference over a laptop or cell phone, weighing scale, and be able to learn to take blood pressure, among others.

• Based on local practice, Participants that cannot consent may have Caregiver's consent provided the Caregiver has among others a) Power of Attorney, b) is a spouse, or c) a sibling or d) a child or e) a close relation. The practice of accepting consent must be consistent with established practice at the site and jurisdiction.

• Participants must consent to CYP450 and apolipoprotein E (ApoE) genotyping, and pharmacokinetics.

• Diagnosis of AD by NIA-AA criteria

• Clinically significant Agitation assessed by:

∙ NPI (Agitation) ≥ 4

‣ The presence of clinically significant, persistent Agitation based on the IPA definition (Appendix C) rather than those with recent onset and occasional symptoms, and

‣ Agitation not attributable to another psychiatric disorder, suboptimal care conditions, other underlining medical condition, or the physiological effects of a substance.

• Negative drug screen, except for benzodiazepines if Participant has been using them in stable doses for at least 3 months before screening.

• All medications used for behavioral symptoms should be consistent for at least 6 weeks before screening, with allowance for dose changes up to 25%.

⁃ Women must be of no childbearing potential (postmenopausal, defined as cessation of menses for at least 12 months, without an alternative medical cause for amenorrhea) or surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation)).

• An individual who meets any of the following criteria will be excluded from participation in this study: