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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Actinogen Medical
• Collaborator: Avance Clinical

Criteria

Inclusion Criteria:

1. Male or female aged 50 to 80

2. Body mass index 17.5 to < 35 kg/m2, inclusive at the time of screening

3. Mini-Mental State Score of ≥ 25 points at screening

4. Must provide written informed consent

Exclusion Criteria:

1. Abnormalities in vital signs at screening or baseline

2. Clinically significant abnormal hematology or biochemistry values, as determined by the investigator at screening and/or baseline.

3. Previous clinically significant systemic illness or infection within the past 4 weeks prior to screening or baseline, as determined by the investigator

4. Clinically significant ECG abnormalities

5. Use of tobacco- or nicotine-containing products in the past month or unwillingness to abstain during study participation

6. Participation in another clinical study of a drug or device

7. Known allergy to the study drug (Xanamem®) or any of the excipients

8. 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

9. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies at screening

10. Subjects with a history of drug abuse or addiction in the past 5 years.

11. 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)