Xanamem® in Adults with Major Depressive Disorder and Impaired Cognition (XanaCIDD)

Key Inclusion Criteria:

• Male or female aged 18 to 75, inclusive.

• Positive MDD primary diagnosis confirmed by the Mini-International NeuropsychiatricInterview (MINI).

• Persistent depressive symptoms as determined by a Hamilton Depression Rating Scale (HAM-D) ≥ 17 at Screening.

• Cognitive abilities on a coding test > 0.5 standard deviations below expected.

• Self-reported subjective cognitive dysfunction.

• Currently or previously treated with a stable dose of a first- or second-lineantidepressant that is approved for the treatment of depression (but not a tricyclicantidepressant, monoamine oxidase inhibitor, or vortioxetine). If on currenttreatment, dose must be stable for at least 6 weeks.

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

• Able to comfortably abstain from caffeine intake for 4 hours prior to scheduledcognitive assessments.

• Must provide written informed consent to participate in the trial and be willing andable to comply with the requirements of the protocol and complete all trial visits.

Key Exclusion Criteria:

• Active suicidal ideation within the previous 3 months

• On a tricyclic antidepressant, monoamine oxidase inhibitor, esketamine, orvortioxetine.

• A history of clinically diagnosed dementia of any type

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

• Has a BMI or body weight that will interfere with participation in the trial

• Type I or Type II diabetes requiring insulin

• Clinically significant ECG abnormalities

• Participation in another clinical trial of a drug or device

• Trial participants who in the opinion of the Investigator exhibit physical,cognitive, or language impairments of such severity as to adversely affect thevalidity of the data derived from the neuropsychological tests.

• Positive testing for HIV, hepatitis B surface antigen, or hepatitis C antibodies atScreening.

• Participants with a history of drug abuse or addiction in the past 2 years

• Current use of cannabis/marijuana, or tetrahydrocannabinol-containing medications.