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

Primary Purpose

Mild Cognitive Impairment, Alzheimer's Disease

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

Xanamem® 5 mg

Placebo

Xanamem® 10 mg

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Cognitive Function, Healthy Volunteers

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy 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)

Sites / Locations

Paratus Clinical Research Canberra
Paratus Clinical Research Western Sydney
Paratus Clinical Research Central Coast
Paratus Clinical Research Brisbane
USC Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Xanamem® 5 mg

Xanamem® 10 mg

Placebo

Arm Description

Oral Xanamem® capsules 5 mg, to be administered once daily

Oral Xanamem® capsules 10 mg, to be administered once daily

Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT04983368

First Posted

July 17, 2021

Last Updated

April 6, 2022

Sponsor

Actinogen Medical

Collaborators

Avance Clinical Pty Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04983368

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

June 30, 2021 (Actual)

Primary Completion Date

February 11, 2022 (Actual)

Study Completion Date

February 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Actinogen Medical

Collaborators

Avance Clinical Pty Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment, Alzheimer's Disease

Keywords

Cognitive Function, Healthy Volunteers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Volunteer subjects will be randomly assigned to 1 of 3 treatment groups to receive either 5 mg Xanamem®, 10 mg Xanamem® or placebo in the ratio of 1:1:1 with approximately 35 subjects in each treatment group. This sample size has been selected to allow for approximately 30 subjects per treatment group to complete the study.

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Study treatment is blinded for participants, investigators.

Allocation

Randomized

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Xanamem® 5 mg

Arm Type

Experimental

Arm Description

Oral Xanamem® capsules 5 mg, to be administered once daily

Arm Title

Xanamem® 10 mg

Arm Type

Experimental

Arm Description

Oral Xanamem® capsules 10 mg, to be administered once daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily.

Intervention Type

Drug

Intervention Name(s)

Xanamem® 5 mg

Intervention Description

Oral Xanamem® ("UE2343") capsules 5 mg, administered orally once daily.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo which is identical in appearance to the test product (5 mg, 10 mg Xanamem® QD) except that it contains no active ingredient.

Intervention Type

Drug

Intervention Name(s)

Xanamem® 10 mg

Intervention Description

Oral Xanamem® ("UE2343") capsules 10 mg, administered orally once daily.

Primary Outcome Measure Information:

Title

Short-term efficacy: Assessment of changes of different doses of Xanamem® on cognition.

Description

Time Frame

Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)

Title

Assessment of safety and tolerability of different Xanamem® doses by the occurrence of Treatment-Emergent Adverse Events (TEAEs).

Description

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.

Time Frame

10 Weeks [Baseline to Week 10 Follow-Up (4 Weeks Post Last Dose of Study Drug)]

Secondary Outcome Measure Information:

Title

Short-term efficacy of different doses of Xanamem® on cognition

Description

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).

Time Frame

Screening, Baseline, Week 2, Week 4, Week 6 (End of Treatment), Week 10 (Follow-Up)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Miriam Roesner

Organizational Affiliation

Actinogen Medical Limited

Official's Role

Study Director

Facility Information:

Facility Name

Paratus Clinical Research Canberra

City

Bruce

State/Province

Australian Capital Territory

ZIP/Postal Code

2617

Country

Australia

Facility Name

Paratus Clinical Research Western Sydney

City

Blacktown

State/Province

New South Wales

ZIP/Postal Code

2148

Country

Australia

Facility Name

Paratus Clinical Research Central Coast

City

Kanwal

State/Province

New South Wales

ZIP/Postal Code

2259

Country

Australia

Facility Name

Paratus Clinical Research Brisbane

City

Albion

State/Province

Queensland

ZIP/Postal Code

4010

Country

Australia

Facility Name

USC Clinical Trials

City

Sippy Downs

State/Province

Queensland

ZIP/Postal Code

4556

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28012176

Citation

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 11beta-hydroxysteroid dehydrogenase type 1 (11beta-HSD1) inhibitor UE2343 (Xanamem). Br J Pharmacol. 2017 Mar;174(5):396-408. doi: 10.1111/bph.13699. Epub 2017 Jan 25.

Results Reference

background

Links:

URL

https://pubmed.ncbi.nlm.nih.gov/28012176/

Description

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

Learn more about this trial

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

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