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 range50 Years – 80 Years
SexALL
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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.
✕. 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
✕
What they're measuring
1
Short-term efficacy: Assessment of changes of different doses of Xanamem® on cognition.
. 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