A Double-Blind, Placebo-Controlled, Dose Ranging Study of Xanamem® in Healthy Elderly Volunteers (NCT04983368) | Clinical Trial Compass
CompletedPhase 1/2
A Double-Blind, Placebo-Controlled, Dose Ranging Study of Xanamem® in Healthy Elderly Volunteers
Australia107 participantsStarted 2021-06-30
Plain-language summary
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.
Who can participate
Age range
50 Years – 80 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
. Male or female aged 50 to 80
. Body mass index 17.5 to \< 35 kg/m2, inclusive at the time of screening
. Mini-Mental State Score of ≥ 25 points at screening
. Must provide written informed consent
Exclusion criteria
. Abnormalities in vital signs at screening or baseline
. Clinically significant abnormal hematology or biochemistry values, as determined by the investigator at screening and/or baseline.
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.
1This trial tested Xanamem in healthy elderly volunteers rather than people already diagnosed with mild cognitive impairment or Alzheimer's — does that mean the results may not directly apply to my situation, and what would that mean for how useful this data is to my care?
2Since this was a Phase 1/2 dose-ranging study, it was primarily focused on finding safe doses and early signals rather than proving the drug works — how much should I read into any positive cognitive findings from a study at this early stage?
3The trial measured Treatment-Emergent Adverse Events across different doses of Xanamem — were there any safety signals or side effects reported that you think would be relevant for someone with my health profile to be aware of?
4Now that this trial is completed, is there a larger follow-up study of Xanamem in people with mild cognitive impairment or Alzheimer's that might be worth considering, or is the evidence still too early to act on?
5Given that this study used a placebo-controlled design in healthy volunteers, how does the evidence from this trial compare to what we already know about standard approaches for managing early cognitive decline — is there a proven option I should consider first??
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
Short-term efficacy: Assessment of changes of different doses of Xanamem® on cognition.
. Previous clinically significant systemic illness or infection within the past 4 weeks prior to screening or baseline, as determined by the investigator
. Clinically significant ECG abnormalities
. Use of tobacco- or nicotine-containing products in the past month or unwillingness to abstain during study participation
. Participation in another clinical study of a drug or device
. Known allergy to the study drug (Xanamem®) or any of the excipients
. Subjects who are likely to be unable to comply with the study schedule and/ or subjects with an inability to communicate well with the investigator