A Double-Blind, Placebo-Controlled, Dose Ranging Study of Xanamem® in Healthy Elderly Volunteers

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
• 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
• Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies at screening
• Subjects with a history of drug abuse or addiction in the past 5 years.
• Evidence of alcohol abuse (defined as greater than 21 standard units per week for males and greater than 14 standard units per week for females)