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| Name | Class |
|---|---|
| Avance Clinical Pty Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xanamem® 5 mg | Experimental | Oral Xanamem® capsules 5 mg, to be administered once daily |
|
| Xanamem® 10 mg | Experimental | Oral Xanamem® capsules 10 mg, to be administered once daily |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xanamem® 5 mg | Drug | Oral Xanamem® ("UE2343") capsules 5 mg, administered orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 10 Weeks [Baseline to Week 10 Follow-Up (4 Weeks Post Last Dose of Study Drug)] |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Screening, Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miriam Roesner | Actinogen Medical Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paratus Clinical Research Canberra | Bruce | Australian Capital Territory | 2617 | Australia | ||
| Paratus Clinical Research Western Sydney |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28012176 | Background | 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. |
| Label | URL |
|---|---|
| Selection and early clinical evaluation of the brain-penetrant 11β-HSD1 inhibitor UE2343 | View source |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000621522 | UE2343 |
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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.
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Study treatment is blinded for participants, investigators.
| Placebo | Drug | 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 mg | Drug | Oral Xanamem® ("UE2343") capsules 10 mg, administered orally once daily. |
|
| Blacktown |
| New South Wales |
| 2148 |
| Australia |
| Paratus Clinical Research Central Coast | Kanwal | New South Wales | 2259 | Australia |
| Paratus Clinical Research Brisbane | Albion | Queensland | 4010 | Australia |
| USC Clinical Trials | Sippy Downs | Queensland | 4556 | Australia |