Major Depressive DisorderPhase 2NCT05657691
Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition (XanaCIDD)
A Phase 2 study testing Xanamem™ in people with Major Depressive Disorder and MDD, run by Actinogen Medical at 12 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder, MDD, Cognitive Impairment
- What is being tested?
- Xanamem™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 28 Nov 2022to 1 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Australia7 sites
Paratus Clinical Research Western Sydney
Blacktown, New South Wales
Paratus Clinical Research Brisbane
Brisbane, Queensland
Ramsay Clinic Albert Road
Melbourne, Victoria, 3004
Monash Alfred Psychiatry Research Centre
Melbourne, Victoria
Genesis Research Services
Newcastle, New South Wales
NeuroCentrix
Noble Park, Victoria
USC Clinical Trials
Sippy Downs, Queensland
United Kingdom5 sites
St Pancras Clinical Research
London, EC2Y 8EA
Clerkenwell Health
London, W1G 8DR
MAC Clinical Research - Manchester
Manchester, M13 9NQ
Glasgow Memory Clinic
Motherwell, ML1 4UF
MAC Clinical Research - South Yorkshire
Tankersley, S75 3DL
About this study
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
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.
- Conditions
- Major Depressive Disorder, MDD, Cognitive Impairment
- Being tested
- Xanamem™, Placebo
- Keywords
- Xanamem, UE2343, Actinogen, Cortisol, 11β-HSD1, 11-beta-Hydroxysteroid Dehydrogenase Type 1, emestedastat
- Medical subject headings
- Depressive Disorder, Major, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xanamem™Drug
Also called UE2343
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.
PlaceboDrug
Matching placebo which is identical in appearance to the test product (10 mg Xanamem™ QD) except that it contains no active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| 10 mg Xanamem™ | Experimental | 10 mg Xanamem™ capsule, to be administered orally once every morning with or without food Receives: Drug: Xanamem™ |
| Placebo | Placebo comparator | Placebo capsule, to be administered orally once every morning with or without food Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 Weeks (Baseline to Week 6 (end of treatment (EOT)))
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
Measured: 6 Weeks (Baseline to Week 6 (EOT))
Secondary outcomes (1)
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.
Measured: 6 Weeks (Baseline to Week 6 (EOT))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start28 Nov 2022
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo-controlled, parallel-group, double-blind, proof-of-concept trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actinogen Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AXIOM Real Time Metrics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657691
- Sponsor's protocol ID
- ACW0008
- Status last verified
- Jan 2025
- First submitted
- 17 Oct 2022
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05657691
- Acronym / sponsor ID
- ACW0008
- Conditions
- Major Depressive Disorder, MDD, Cognitive Impairment
- Keywords
- Xanamem, UE2343, Actinogen, Cortisol, 11β-HSD1, 11-beta-Hydroxysteroid Dehydrogenase Type 1, emestedastat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Actinogen MedicalIndustry (pharma, biotech, devices)
- Collaborators
- AXIOM Real Time Metrics
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- placebo-controlled, parallel-group, double-blind, proof-of-concept trial
| Arm | Type | Receives |
|---|---|---|
| 10 mg Xanamem™ | Experimental | Drug: Xanamem™10 mg Xanamem™ capsule, to be administered orally once every morning with or without food |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule, to be administered orally once every morning with or without food |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xanamem™Also: UE2343Xanamem™ 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. | Drug | 10 mg Xanamem™ |
| PlaceboMatching placebo which is identical in appearance to the test product (10 mg Xanamem™ QD) except that it contains no active ingredient. | Drug | Placebo |
Primary outcome
Efficacy of Xanamem on attention, including working memory
Time frame: 6 Weeks (Baseline to Week 6 (end of treatment (EOT)))
Change from Baseline to EOT in an Attention Composite of a Cognitive Test Battery (CTB) (Detection, Identification, and One Back tests)
Evaluation of the short-term safety and tolerability of Xanamem
Time frame: 6 Weeks (Baseline to Week 6 (EOT))
Incidence and severity of treatment-emergent adverse events (TEAEs) Incidence of serious adverse events (SAEs) and SUSARs
1 secondary outcome
Determine the effects of Xanamem on depressive symptoms
Time frame: 6 Weeks (Baseline to Week 6 (EOT))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Selection and early clinical evaluation of the brain-penetrant 11β-HSD1 inhibitor UE2343Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xanamem™ in people with Major Depressive Disorder and MDD, run by Actinogen Medical at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Xanamem on attention, including working memory (time frame: 6 Weeks (Baseline to Week 6 (end of treatment (EOT)))). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.