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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
107
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.
Paratus Clinical Research Canberra
Bruce, Australian Capital Territory, Australia
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, Australia
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia
Paratus Clinical Research Brisbane
Albion, Queensland, Australia
USC Clinical Trials
Sippy Downs, Queensland, Australia
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)
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