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

• Status: Recruiting
• Trial end date: 2024-06-15
• Target enrollment: 0
• Participant gender: All

Summary

Xanamem is being developed as a potential treatment for symptomatic, early stages of Alzheimer's Disease (AD) and Major Depressive Disorder (MDD).

This XanaCIDD Phase II study in MDD is to investigate the safety and efficacy of Xanamem™ in treating patients with cognitive and depressive symptoms. Trial participants will be randomized to either receive 10mg of Xanamem™ once daily or a Placebo at a 1:1 ratio in a double-blinded fashion.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actinogen Medical
• Collaborator: AXIOM Real Time Metrics

Criteria

Key Inclusion Criteria:

• Male or female aged 18 to 70, inclusive

• Positive MDD primary diagnosis confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.)

• 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

• On a stable dose of a first- or second-line antidepressant that is approved for the treatment of depression (but not a tricyclic antidepressant, monoamine oxidase inhibitor, or vortioxetine) drug for at least 6 weeks.

• BMI 17.5 to 38 kg/m2.

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

Key Exclusion Criteria:

• Active suicidal ideation

• On a tricyclic antidepressant, monoamine oxidase inhibitor, or vortioxetine.

• A history of clinically diagnosed dementia of any type.

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

• Type I or Type II diabetes requiring insulin.

• Clinically significant ECG abnormalities

• Smokers of > 5 cigarettes a day or equivalent nicotine (includes vaping) / tobacco products.

• 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 the validity of the data derived from the neuropsychological tests.

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

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

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