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

Mild Cognitive Impairment Clinical Trial

— XanaMIA-DR  

Official title:

XanaMIA-DR A Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy, Pharmacodynamics and Safety of Xanamem® in Healthy Elderly Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04983368
• Other study ID #: ACW0005
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 30, 2021
• Est. completion date: February 11, 2022

Study information

• Verified date: April 2022
• Source: Actinogen Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: February 11, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Drug:
• Xanamem® 5 mg
Oral Xanamem® ("UE2343") capsules 5 mg, administered orally once daily.
• Placebo
Matching placebo which is identical in appearance to the test product (5 mg, 10 mg Xanamem® QD) except that it contains no active ingredient.
• Xanamem® 10 mg
Oral Xanamem® ("UE2343") capsules 10 mg, administered orally once daily.

Locations

Country	Name	City	State
Australia	Paratus Clinical Research Brisbane	Albion	Queensland
Australia	Paratus Clinical Research Western Sydney	Blacktown	New South Wales
Australia	Paratus Clinical Research Canberra	Bruce	Australian Capital Territory
Australia	Paratus Clinical Research Central Coast	Kanwal	New South Wales
Australia	USC Clinical Trials	Sippy Downs	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Actinogen Medical	Avance Clinical

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Webster SP, McBride A, Binnie M, Sooy K, Seckl JR, Andrew R, Pallin TD, Hunt HJ, Perrior TR, Ruffles VS, Ketelbey JW, Boyd A, Walker BR. Selection and early clinical evaluation of the brain-penetrant 11ß-hydroxysteroid dehydrogenase type 1 (11ß-HSD1) inhibitor UE2343 (Xanamem™). Br J Pharmacol. 2017 Mar;174(5):396-408. doi: 10.1111/bph.13699. Epub 2017 Jan 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term efficacy: Assessment of changes of different doses of Xanamem® on cognition.	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.	Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)
Primary	Assessment of safety and tolerability of different Xanamem® doses by the occurrence of Treatment-Emergent Adverse Events (TEAEs).	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.	10 Weeks [Baseline to Week 10 Follow-Up (4 Weeks Post Last Dose of Study Drug)]
Secondary	Short-term efficacy of different doses of Xanamem® on cognition	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).	Screening, Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)

External Links

•   Selection and early clinical evaluation of the brain-penetrant 11ß-HSD1 inhibitor UE2343