Peripheral Neuropathy Clinical Trial
Official title:
XanaHES: A Phase I, Single Blinded, Central Reader Blinded, Placebo-Controlled, Dose Escalation Study of Xanamem™ to Assess Safety and Tolerability in Healthy Elderly Subjects
Xanamem™ is being developed as a potential drug for 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 Alzheimer's disease.
The XanaHES study is testing the safety and tolerability of Xanamem. It is planned to enrol
approximately 84 participants, male and female aged from 50 to 75 who are in good health, in
the study at 1 centre in Australia.
The XanaHES Phase I study is a single-blind study. Subjects will be randomised to receive
either 20mg once daily Xanamem or Placebo in cohort 1. Once all subjects have completed the
study treatment of 12 weeks, a dose escalation committee will decide if a new cohort, cohort
2, with 30mg once daily vs placebo is started.
This is a Phase I, randomised, single-centre, single-blind, placebo-controlled study to
assess the safety, tolerability of oral Xanamem once daily in healthy elderly subjects.
It is planned to randomise approximately 84 subjects, 42 in each cohort, at a single site in
Australia.
Cohort 1 starts with a 20mg QD dose vs matching placebo. A Dose Escalation Committee will
review the results from cohort 1 and provide a recommendation to proceed with Cohort 2
randomisation which involves a dose escalation to 30mg.
At the Baseline visit (Week 0), eligible subjects will be randomised on a 30:12 ratio to
receive either Xanamem administered orally QD (treatment group) or matching placebo (placebo
group). Subjects will return to the study site for visits at Week 2, Week 4, Week 6, Week 8,
Week 10, End of Treatment (Week 12) and Follow-up (4 weeks post last dose of study drug)
visits, at which study assessments will be performed.
Ad hoc telephone contact may also occur at any other time-point throughout the study, if
deemed necessary by the investigator/study nurse, or if the subject wishes to report an
adverse event (AE).
Subjects will be interviewed and examined at the study site at each visit and will complete a
variety of questionnaires, routine safety evaluations and nerve function tests.
A central reader will review every Nerve Function Monitoring (NFM) assessment performed for
each subject for Potential Nerve Safety Signals (PNSS).
Optional cerebrospinal fluid (CSF) sampling will be performed at baseline and end of
treatment visits for a small subgroup of subjects, who provide additional consent. Subjects
who do not provide consent for this optional sub-study will still be eligible for the main
study.
The overall study duration for an individual subject will be 17 to 20 weeks, including a
screening period of up to 4 weeks, a single-blind treatment period of 12 weeks, and a
follow-up period of 4 weeks. The total duration of the study is expected to be 1.5 years.
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