Xanamem™ in Healthy Elderly Subjects (NCT03830762) | Clinical Trial Compass
CompletedPhase 1
Xanamem™ in Healthy Elderly Subjects
Australia42 participantsStarted 2019-01-21
Plain-language summary
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.
Who can participate
Age range
50 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Volunteers aged 50 to 75 years.
. Female subjects:
. Post-menopausal women, defined as no menses for 12 months without an alternative medical cause. If there is any concern about the menopausal status of a prospective female subject, a follicle stimulating hormone test (FSH) should be requested to confirm post-menopausal status. Post-menopausal women confirmed by FSH level \> 40 mIU/mL, will be confirmed by the local laboratory.
. Women of childbearing potential (WOCBP) must have a negative pregnancy test.
. Male Subjects:
. Who are sexually active, fertile men must use highly effective methods of contraception from Day 1 until 3 months after last dose of study drug if their partners are WOCBP
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events (AEs)
Timeframe: 20 Weeks (Screening up to Week 16 Follow-Up [4 Weeks Post Last Dose of Study Drug ± 4 Days])
2
Incidence of Clinically Significant Changes in Serum Biomarker Levels in a Standard Serum Chemistry Panel
Timeframe: Screening up to Week 16 (Follow-Up [4 Weeks Post Last Dose of Study Drug ± 4 Days])
3
Incidence of Clinically Significant Laboratory Haematological Biomarker Levels in a Standard Haematology Panel.
Timeframe: Screening up to Week 16 (Follow-Up [4 Weeks Post Last Dose of Study Drug ± 4 Days])
4
Incidence of Clinically Significant Changes or Abnormalities Following Physical Examination
Timeframe: Screening up to Week 16 (Follow-Up) and Unscheduled Safety Visit throughout duration of study up to Week 16 (Follow-Up Visit [4 Weeks Post Last Dose of Study Drug ± 4 Days])
5
Nerve Conduction Assessments
Timeframe: Screening up to Week 16 (Follow-Up Visit [4 Weeks Post Last Dose of Study Drug ± 4 Days])
6
Neuropathy Total Symptom Score-6 (NTSS-6)
Timeframe: Screening, Week 2, Week 4, Week 8, Week 12 (End of Treatment), Week 16 (Follow-Up) and Telephone Contact (Ad Hoc)
. Who are permanently sterile or have had bilateral orchiectomy or bilateral vasectomy.
. No disease which may cause a peripheral neuropathy.
Exclusion criteria
. Clinically significant abnormalities in vital signs (blood pressure, heart rate, respiration rate and oral temperature), as determined by the investigator.
. Body Mass Index (BMI) \> 38 kg/m2
. Clinically significant abnormal haematology, biochemistry and urine examination values, as determined by the investigator.
. Participants who have a history of liver disease, including fatty liver, or LFT elevations requiring investigation will not be eligible.
. Has had a significant systemic illness or infection within the past 4 weeks prior to randomisation, as determined by the investigator.
. Documented diagnosis of Type I or Type II diabetes.
. Has a history of disease directly related to the hypothalamus, the pituitary and/or the adrenal glands which affects the hypothalamic-pituitary-adrenal axis function.
. Has any uncontrolled clinical condition relating to glucose or lipid metabolism.
7
Toronto Clinical Neuropathy Score (TCNS)
Timeframe: Screening, Week 2, Week 4, Week 8, Week 12 (End of Treatment), Week 16 (Follow-Up) and Telephone Contact (Ad Hoc)
8
Skin Biopsy
Timeframe: At Baseline and Week 12 (End of Treatment)
9
Quantitative Sensory Testing (QST)
Timeframe: Screening up to Week 16 (Follow-Up Visit [4 Weeks Post Last Dose of Study Drug ± 4 Days])