Xanamem™ in Healthy Elderly Subjects

Exclusion Criteria

• •1. Clinically significant abnormalities in vital signs (blood pressure, heart rate, respiration rate and oral temperature), as determined by the investigator.
• •2. Body Mass Index (BMI) \> 38 kg/m2
• •3. Clinically significant abnormal haematology, biochemistry and urine examination values, as determined by the investigator.
• •4. Participants who have a history of liver disease, including fatty liver, or LFT elevations requiring investigation will not be eligible.
• •5. Has had a significant systemic illness or infection within the past 4 weeks prior to randomisation, as determined by the investigator.
• •6. Documented diagnosis of Type I or Type II diabetes.
• •7. 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.
• •8. Has any uncontrolled clinical condition relating to glucose or lipid metabolism.
• •9. Subjects with clinical evidence of peripheral neuropathy or historical evidence of clinically significant nerve conduction abnormalities. Clinical evidence of neuropathy.
• •10. Clinically significant electrocardiogram (ECG) abnormalities, including QTc interval \> 450 msec (male) and \> 470 msec (female), following ECG tracings at Screening.
• •11. Use of any prohibited medication.
• •12. Participation in another clinical study of a drug or device whereby the last investigational drug/device administration is within 60 days of Screening.
• •13. Inability to communicate well with the investigator (i.e. language problem, non-fluent English \[as questionnaires and study drug label will be provided in English only\], poor mental development or impaired cerebral function).
• •14. Subject will undergo the Columbia Suicide Severity Rating Scale (CSSRS), Toronto Clinical Neuropathy Score (TCNS), EuroQoL Health Related Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L), and Cogstate Test Battery at the indicated time-points to avoid uncontrolled learning effects. Subjects who need to perform these tests externally to and in parallel with this study will be excluded.
• •15. For subjects that consent, and are subsequently accepted for enrolled into, the CSF optional sub-study, subjects must have no contraindications to the lumbar puncture procedure as assessed by the Principal Investigator. Such contraindications may include uncontrolled bleeding abnormalities or skin or spine abnormalities.
• •16. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV). Subjects returning a positive result will be managed by the site in line with standard care.