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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05657691




Registration number
NCT05657691
Ethics application status
Date submitted
17/10/2022
Date registered
20/12/2022
Date last updated
10/07/2024

Titles & IDs
Public title
Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition (XanaCIDD)
Scientific 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
Secondary ID [1] 0 0
ACW0008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
MDD 0 0
Cognitive Impairment 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Xanamem™
Treatment: Drugs - Placebo

Experimental: 10 mg Xanamem™ - 10 mg Xanamem™ capsule, to be administered orally once every morning with or without food

Placebo comparator: Placebo - Placebo capsule, to be administered orally once every morning with or without food


Treatment: Drugs: 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.

Treatment: Drugs: Placebo
Matching placebo which is identical in appearance to the test product (10 mg Xanamem™ QD) except that it contains no active ingredient.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy of Xanamem on attention, including working memory
Timepoint [1] 0 0
6 Weeks (Baseline to Week 6 (end of treatment (EOT)))
Primary outcome [2] 0 0
Evaluation of the short-term safety and tolerability of Xanamem
Timepoint [2] 0 0
6 Weeks (Baseline to Week 6 (EOT))
Secondary outcome [1] 0 0
Determine the effects of Xanamem on depressive symptoms
Timepoint [1] 0 0
6 Weeks (Baseline to Week 6 (EOT))

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2024
Sample size
Target
Accrual to date
Final
167
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research Western Sydney - Blacktown
Recruitment hospital [2] 0 0
Genesis Research Services - Newcastle
Recruitment hospital [3] 0 0
Paratus Clinical Research Brisbane - Brisbane
Recruitment hospital [4] 0 0
USC Clinical Trials - Sippy Downs
Recruitment hospital [5] 0 0
Ramsay Clinic Albert Road - Melbourne
Recruitment hospital [6] 0 0
Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment hospital [7] 0 0
NeuroCentrix - Noble Park
Recruitment postcode(s) [1] 0 0
- Blacktown
Recruitment postcode(s) [2] 0 0
- Newcastle
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Sippy Downs
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment postcode(s) [7] 0 0
- Noble Park
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
London
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Manchester
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Motherwell
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Tankersley

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Actinogen Medical
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
AXIOM Real Time Metrics
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05657691
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05657691