Clinical trial NCT05657691: Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition (XanaCIDD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
MDD
Cognitive Impairment
Keywords: Xanamem
UE2343
Actinogen
Cortisol
11β-HSD1
11-beta-Hydroxysteroid Dehydrogenase Type 1
emestedastat
Lead sponsor: Actinogen Medical
Sponsor class: INDUSTRY
Collaborators: name: AXIOM Real Time Metrics
First posted: 2022-12-20
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: placebo-controlled, parallel-group, double-blind, proof-of-concept trial
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of Xanamem on attention, including working memory
timeFrame: 6 Weeks (Baseline to Week 6 (end of treatment (EOT)))
measure: Evaluation of the short-term safety and tolerability of Xanamem
timeFrame: 6 Weeks (Baseline to Week 6 (EOT))
Secondary outcomes:
measure: Determine the effects of Xanamem on depressive symptoms
timeFrame: 6 Weeks (Baseline to Week 6 (EOT))
Other outcomes:
Locations:
city: Blacktown
country: Australia
facility: Paratus Clinical Research Western Sydney
state: New South Wales
city: Newcastle
country: Australia
facility: Genesis Research Services
state: New South Wales
city: Brisbane
country: Australia
facility: Paratus Clinical Research Brisbane
state: Queensland
city: Sippy Downs
country: Australia
facility: USC Clinical Trials
state: Queensland
city: Melbourne
country: Australia
facility: Ramsay Clinic Albert Road
state: Victoria
city: Melbourne
country: Australia
facility: Monash Alfred Psychiatry Research Centre
state: Victoria
city: Noble Park
country: Australia
facility: NeuroCentrix
state: Victoria
city: London
country: United Kingdom
facility: St Pancras Clinical Research
city: London
country: United Kingdom
facility: Clerkenwell Health
city: Manchester
country: United Kingdom
facility: MAC Clinical Research - Manchester
city: Motherwell
country: United Kingdom
facility: Glasgow Memory Clinic
city: Tankersley
country: United Kingdom
facility: MAC Clinical Research - South Yorkshire
Study officials:
References: