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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05657691
Other study ID # ACW0008
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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))
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