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

Major Depressive Disorder Clinical Trial

Official title:

XanaCIDD: A Double-Blind, Randomized, Placebo Controlled, Parallel-Group Trial to Assess the Safety, Tolerability, and Efficacy of Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05657691
• Other study ID #: ACW0008
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 28, 2022
• Est. completion date: July 15, 2024

Study information

• Verified date: April 2024
• Source: Actinogen Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: July 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

• Male or female aged 18 to 75, inclusive.
• Positive MDD primary diagnosis confirmed by the Mini-International Neuropsychiatric Interview (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-line antidepressant that is approved for the treatment of depression (but not a tricyclic antidepressant, monoamine oxidase inhibitor, or vortioxetine). If on current treatment, dose must be stable for at least 6 weeks.
• Smokers are eligible if they are able to comfortably abstain from nicotine for 2 hours prior to scheduled cognitive assessments.
• Able to comfortably abstain from caffeine intake for 4 hours prior to scheduled cognitive assessments.
• 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 within the previous 3 months
• On a tricyclic antidepressant, monoamine oxidase inhibitor, esketamine, 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
• 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 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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• MDD

Intervention

Drug:
• Xanamem™
Xanamem™ is formulated in green and cream-colored size 3, Coni-Snap-shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains the active pharmaceutical ingredient of UE2343.
• Placebo
Matching placebo which is identical in appearance to the test product (10 mg Xanamem™ QD) except that it contains no active ingredient.

Locations

Country	Name	City	State
Australia	Paratus Clinical Research Western Sydney	Blacktown	New South Wales
Australia	Paratus Clinical Research Brisbane	Brisbane	Queensland
Australia	Monash Alfred Psychiatry Research Centre	Melbourne	Victoria
Australia	Ramsay Clinic Albert Road	Melbourne	Victoria
Australia	Genesis Research Services	Newcastle	New South Wales
Australia	NeuroCentrix	Noble Park	Victoria
Australia	USC Clinical Trials	Sippy Downs	Queensland
United Kingdom	Clerkenwell Health	London
United Kingdom	St Pancras Clinical Research	London
United Kingdom	MAC Clinical Research - Manchester	Manchester
United Kingdom	Glasgow Memory Clinic	Motherwell
United Kingdom	MAC Clinical Research - South Yorkshire	Tankersley

Sponsors (2)

Lead Sponsor	Collaborator
Actinogen Medical	AXIOM Real Time Metrics

Countries where clinical trial is conducted

Australia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Xanamem on attention, including working memory	Change from Baseline to EOT in an Attention Composite of a Cognitive Test Battery (CTB) (Detection, Identification, and One Back tests)	6 Weeks (Baseline to Week 6 (end of treatment (EOT)))
Primary	Evaluation of the short-term safety and tolerability of Xanamem	Incidence and severity of treatment-emergent adverse events (TEAEs) Incidence of serious adverse events (SAEs) and SUSARs	6 Weeks (Baseline to Week 6 (EOT))
Secondary	Determine the effects of Xanamem on depressive symptoms	Change from Baseline to EOT on the Montgomery-Åsberg Depression Rating Scale (MADRS).; The MADRS is a 10-item diagnostic questionnaire used to assess the severity of depressive episodes and is designed to be sensitive to treatment effects. Each item is scored from 0 to 6, and overall scores range from 0 to 60. Higher scores indicate greater severity.	6 Weeks (Baseline to Week 6 (EOT))

External Links

•   Selection and early clinical evaluation of the brain-penetrant 11ß-HSD1 inhibitor UE2343