A Phase 1/2 interventional study of Xanamem® 5 mg and Placebo in Mild Cognitive Impairment and Alzheimer's Disease, sponsored by Actinogen Medical. Completed at 5 sites in Australia. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by Actinogen Medical · Phase 1/2, Interventional, and Treatment
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 107 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Actinogen Medical is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral Xanamem® capsules 5 mg, to be administered once daily
Drug: Xanamem® 5 mg
Oral Xanamem® capsules 10 mg, to be administered once daily
Drug: Xanamem® 10 mg
Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily.
Drug: Placebo
Oral Xanamem® ("UE2343") capsules 5 mg, administered orally once daily.
Matching placebo which is identical in appearance to the test product (5 mg, 10 mg Xanamem® QD) except that it contains no active ingredient.
Oral Xanamem® ("UE2343") capsules 10 mg, administered orally once daily.
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.
Time frame: 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.
Time frame: 10 Weeks [Baseline to Week 10 Follow-Up (4 Weeks Post Last Dose of Study Drug)]
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).
Time frame: Screening, Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)
Plan to share: No
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Actinogen Medical