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

Phase 1

Completed

• Conditions: Mild Cognitive Impairment; Alzheimer's Disease
• Interventions: Drug: Xanamem® 5 mg; Drug: Xanamem® 10 mg; Drug: Placebo

• Registration Number: NCT04983368
• Lead Sponsor: Actinogen Medical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-30
• Study First Submitted: 2021-07-17
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-30
• Primary Completion: 2022-02-11
• Study Completion: 2022-02-11
• Status Verified: 2022-04
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xanamem® 5 mg	Xanamem® 5 mg	Oral Xanamem® capsules 5 mg, to be administered once daily
Xanamem® 10 mg	Xanamem® 10 mg	Oral Xanamem® capsules 10 mg, to be administered once daily
Placebo	Placebo	Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily.

Primary Outcome Measures

Name	Time	Method
Short-term efficacy: Assessment of changes of different doses of Xanamem® on cognition.	Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)	Using a tailored Cogstate Neuropsychological Test Battery (NTB), changes from baseline, as well as composite scores based on a combination of these variables at each treatment visit \[Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)\] will be analyzed.
Assessment of safety and tolerability of different Xanamem® doses by the occurrence of Treatment-Emergent Adverse Events (TEAEs).	10 Weeks [Baseline to Week 10 Follow-Up (4 Weeks Post Last Dose of Study Drug)]	The number, type, and severity of Treatment-Emergent Adverse Events (TEAEs) that are reported from Baseline to Follow-up Visit will be collected and evaluated.

Secondary Outcome Measures

Name	Time	Method
Short-term efficacy of different doses of Xanamem® on cognition	Screening, Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)	Using the International Daily Digit Symbol Substitution Test-Symbols, to analyze changes from Screening to, Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up).

Trial Locations

Locations (5)

Paratus Clinical Research Canberra; 🇦🇺 Bruce, Australian Capital Territory, Australia

Paratus Clinical Research Western Sydney; 🇦🇺 Blacktown, New South Wales, Australia

Paratus Clinical Research Central Coast; 🇦🇺 Kanwal, New South Wales, Australia

Paratus Clinical Research Brisbane; 🇦🇺 Albion, Queensland, Australia

USC Clinical Trials; 🇦🇺 Sippy Downs, Queensland, Australia