Mild Cognitive ImpairmentPhase 1/2XanaMIA-DRNCT04983368
A Double-Blind, Placebo-Controlled, Dose Ranging Study of Xanamem® in Healthy Elderly Volunteers
A Phase 1/2 study testing Xanamem® 5 mg and Xanamem® 10 mg in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Actinogen Medical at 5 sites in Australia.
Trial summary
Xanamem® is being developed as a potential drug for Mild Cognitive Impairment in Alzheimer's disease. This study drug has been designed to change the cortisol levels in the brain. Cortisol is a naturally occurring hormone in the body. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease
- What is being tested?
- Xanamem® 5 mg and Xanamem® 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 5 sitesAustralia
- Study dates
- 30 Jun 2021to 11 Feb 2022
- Phase
- Phase 1/2
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 50 to 80
- Body mass index 17.5 to < 35 kg/m2, inclusive at the time of screening
- Mini-Mental State Score of ≥ 25 points at screening
- Must provide written informed consent
Who cannot join
- Abnormalities in vital signs at screening or baseline
- Clinically significant abnormal hematology or biochemistry values, as determined by the investigator at screening and/or baseline.
- Previous clinically significant systemic illness or infection within the past 4 weeks prior to screening or baseline, as determined by the investigator
- Clinically significant ECG abnormalities
- Use of tobacco- or nicotine-containing products in the past month or unwillingness to abstain during study participation
- Participation in another clinical study of a drug or device
Show all 11Show fewer
- Known allergy to the study drug (Xanamem®) or any of the excipients
- Subjects who are likely to be unable to comply with the study schedule and/ or subjects with an inability to communicate well with the investigator
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies at screening
- Subjects with a history of drug abuse or addiction in the past 5 years.
- Evidence of alcohol abuse (defined as greater than 21 standard units per week for males and greater than 14 standard units per week for females)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Paratus Clinical Research Brisbane
Albion, Queensland, 4010
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, 2148
Paratus Clinical Research Canberra
Bruce, Australian Capital Territory, 2617
Paratus Clinical Research Central Coast
Kanwal, New South Wales, 2259
USC Clinical Trials
Sippy Downs, Queensland, 4556
About this study
Official title: XanaMIA-DR a Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy, Pharmacodynamics and Safety of Xanamem® in Healthy Elderly Volunteers
Xanamem® is being developed as a potential drug for Mild Cognitive Impairment in Alzheimer's disease. This study drug has been designed to change the cortisol levels in the brain. Cortisol is a naturally occurring hormone in the body. It is believed that reducing the level of cortisol will be a benefit in the treatment of Mild Cognitive Impairment in Alzheimer's disease.
The purpose of this study in older volunteers is to investigate the smallest dose of Xanamem® (5 mg or 10 mg) which works and to investigate which dose in this study will be used in the upcoming clinical trials in patients.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Being tested
- Xanamem® 5 mg, Placebo, Xanamem® 10 mg
- Keywords
- Cognitive Function, Healthy Volunteers, emestedastat
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xanamem® 5 mgDrug
Oral Xanamem® ("UE2343") capsules 5 mg, administered orally once daily.
PlaceboDrug
Matching placebo which is identical in appearance to the test product (5 mg, 10 mg Xanamem® QD) except that it contains no active ingredient.
Xanamem® 10 mgDrug
Oral Xanamem® ("UE2343") capsules 10 mg, administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Xanamem® 5 mg | Experimental | Oral Xanamem® capsules 5 mg, to be administered once daily Receives: Drug: Xanamem® 5 mg |
| Xanamem® 10 mg | Experimental | Oral Xanamem® capsules 10 mg, to be administered once daily Receives: Drug: Xanamem® 10 mg |
| Placebo | Placebo comparator | Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term efficacy: Assessment of changes of different doses of Xanamem® on cognition.
Using a tailored Cogstate Neuropsychological Test Battery (NTB), changes from baseline, as well as composite scores based on a combination of these variables at each treatment visit [Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)] will be analyzed.
Measured: Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)
Assessment of safety and tolerability of different Xanamem® doses by the occurrence of Treatment-Emergent Adverse Events (TEAEs).
The number, type, and severity of Treatment-Emergent Adverse Events (TEAEs) that are reported from Baseline to Follow-up Visit will be collected and evaluated.
Measured: 10 Weeks [Baseline to Week 10 Follow-Up (4 Weeks Post Last Dose of Study Drug)]
Secondary outcomes (1)
Short-term efficacy of different doses of Xanamem® on cognition
Using the International Daily Digit Symbol Substitution Test-Symbols, to analyze changes from Screening to, Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up).
Measured: Screening, Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start30 Jun 2021
- Primary completion11 Feb 2022
- Study completion11 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Volunteer subjects will be randomly assigned to 1 of 3 treatment groups to receive either 5 mg Xanamem®, 10 mg Xanamem® or placebo in the ratio of 1:1:1 with approximately 35 subjects in each treatment group. This sample size has been selected to allow for approximately 30 subjects per treatment group to complete the study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actinogen Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Responsible party
- Sponsor
- Investigators
- Miriam Roesner, Study director, Actinogen Medical Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983368
- Sponsor's protocol ID
- ACW0005
- Acronym
- XanaMIA-DR
- Status last verified
- Apr 2022
- First submitted
- 17 Jul 2021
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Webster SP, McBride A, Binnie M, Sooy K, Seckl JR, Andrew R, Pallin TD, Hunt HJ, Perrior TR, Ruffles VS, Ketelbey JW, Boyd A, Walker BR. Selection and early clinical evaluation of the brain-penetrant 11beta-hydroxysteroid dehydrogenase type 1 (11beta-HSD1) inhibitor UE2343 (Xanamem). Br J Pharmacol. 2017 Mar;174(5):396-408. doi: 10.1111/bph.13699. Epub 2017 Jan 25.
PubMed 28012176
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XanaMIA-DR a Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy, Pharmacodynamics and Safety of Xanamem® in Healthy Elderly Volunteers
- ClinicalTrials.gov ID
- NCT04983368
- Acronym / sponsor ID
- XanaMIA-DR / ACW0005
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Keywords
- Cognitive Function, Healthy Volunteers, emestedastat
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Actinogen MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 30 Jul 2021 (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 drug for Mild Cognitive Impairment in Alzheimer's disease. This study drug has been designed to change the cortisol levels in the brain. Cortisol is a naturally occurring hormone in the body. It is believed that reducing the level of cortisol will be a benefit in the treatment of Mild Cognitive Impairment in Alzheimer's disease.
The purpose of this study in older volunteers is to investigate the smallest dose of Xanamem® (5 mg or 10 mg) which works and to investigate which dose in this study will be used in the upcoming clinical trials in patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Volunteer subjects will be randomly assigned to 1 of 3 treatment groups to receive either 5 mg Xanamem®, 10 mg Xanamem® or placebo in the ratio of 1:1:1 with approximately 35 subjects in each treatment group. This sample size has been selected to allow for approximately 30 subjects per treatment group to complete the study.
| Arm | Type | Receives |
|---|---|---|
| Xanamem® 5 mg | Experimental | Drug: Xanamem® 5 mgOral Xanamem® capsules 5 mg, to be administered once daily |
| Xanamem® 10 mg | Experimental | Drug: Xanamem® 10 mgOral Xanamem® capsules 10 mg, to be administered once daily |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 50 to 80
- Body mass index 17.5 to < 35 kg/m2, inclusive at the time of screening
- Mini-Mental State Score of ≥ 25 points at screening
- Must provide written informed consent
Key exclusion criteria (11 listed)
- Abnormalities in vital signs at screening or baseline
- Clinically significant abnormal hematology or biochemistry values, as determined by the investigator at screening and/or baseline.
- Previous clinically significant systemic illness or infection within the past 4 weeks prior to screening or baseline, as determined by the investigator
- Clinically significant ECG abnormalities
- Use of tobacco- or nicotine-containing products in the past month or unwillingness to abstain during study participation
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® 5 mgOral Xanamem® ("UE2343") capsules 5 mg, administered orally once daily. | Drug | Xanamem® 5 mg |
| PlaceboMatching placebo which is identical in appearance to the test product (5 mg, 10 mg Xanamem® QD) except that it contains no active ingredient. | Drug | Placebo |
| Xanamem® 10 mgOral Xanamem® ("UE2343") capsules 10 mg, administered orally once daily. | Drug | Xanamem® 10 mg |
Primary outcome
Short-term efficacy: Assessment of changes of different doses of Xanamem® on cognition.
Time frame: Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)
Using a tailored Cogstate Neuropsychological Test Battery (NTB), changes from baseline, as well as composite scores based on a combination of these variables at each treatment visit [Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)] will be analyzed.
Assessment of safety and tolerability of different Xanamem® doses by the occurrence of Treatment-Emergent Adverse Events (TEAEs).
Time frame: 10 Weeks [Baseline to Week 10 Follow-Up (4 Weeks Post Last Dose of Study Drug)]
The number, type, and severity of Treatment-Emergent Adverse Events (TEAEs) that are reported from Baseline to Follow-up Visit will be collected and evaluated.
1 secondary outcome
Short-term efficacy of different doses of Xanamem® on cognition
Time frame: Screening, Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)
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 23 Jan 2025.
- Background: PubMed 28012176Webster SP, McBride A, Binnie M, Sooy K, Seckl JR, Andrew R, Pallin TD, Hunt HJ, Perrior TR, Ruffles VS, Ketelbey JW, Boyd A, Walker BR. Selection and early clinical evaluation of the brain-penetrant 11beta-hydroxysteroid dehydrogenase type 1 (11beta-HSD1) inhibitor UE2343 (Xanamem). Br J Pharmacol. 2017 Mar;174(5):396-408. doi: 10.1111/bph.13699. Epub 2017 Jan 25.
- Selection and early clinical evaluation of the brain-penetrant 11β-HSD1 inhibitor UE2343Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Miriam Roesner study director
Actinogen Medical Limited
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Xanamem® 5 mg and Xanamem® 10 mg in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Actinogen Medical at 5 sites in Australia.
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 4 inclusion and 11 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 23 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 5 sites in Australia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Short-term efficacy: Assessment of changes of different doses of Xanamem® on cognition. (time frame: Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)). 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?
On the ClinicalTrials.gov record for NCT04983368, which also lists 1 linked publication.
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 23 Jan 2025.