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 range50 Years – 75 Years

SexALL

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
✓. Who are permanently sterile or have had bilateral orchiectomy or bilateral vasectomy.
✓. No disease which may cause a peripheral neuropathy.

Exclusion criteria

What they're measuring

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])

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])

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])

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])

Nerve Conduction Assessments

Timeframe: Screening up to Week 16 (Follow-Up Visit [4 Weeks Post Last Dose of Study Drug ± 4 Days])

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)

Trial details

NCT IDNCT03830762

SponsorActinogen Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-07

View on ClinicalTrials.gov More Safety trials

Plain-language summary

Who can participate

Age range50 Years – 75 Years

SexALL

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
✓. Who are permanently sterile or have had bilateral orchiectomy or bilateral vasectomy.
✓. No disease which may cause a peripheral neuropathy.

Exclusion criteria

What they're measuring

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])

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])

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])

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])

Nerve Conduction Assessments

Timeframe: Screening up to Week 16 (Follow-Up Visit [4 Weeks Post Last Dose of Study Drug ± 4 Days])

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)