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

NCT04983368 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ACW0005
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 5

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.

Conditions

Mild Cognitive Impairment; Alzheimer's Disease

Keywords

Cognitive Function; Healthy Volunteers; emestedastat

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (1)

• 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)

Study Arms (3)

Xanamem® 5 mg

EXPERIMENTAL

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

Drug: Xanamem® 5 mg

Xanamem® 10 mg

EXPERIMENTAL

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

Drug: Xanamem® 10 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Xanamem® 5 mg DRUG

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

Xanamem® 5 mg

Placebo DRUG

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

Placebo

Xanamem® 10 mg DRUG

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

Xanamem® 10 mg

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Actinogen Medical: lead
• Avance Clinical Pty Ltd.: collaborator

Study Sites (5)

Paratus Clinical Research Canberra

Bruce, Australian Capital Territory, 2617, Australia

Location

Paratus Clinical Research Western Sydney

Blacktown, New South Wales, 2148, Australia

Location

Paratus Clinical Research Central Coast

Kanwal, New South Wales, 2259, Australia

Location

Paratus Clinical Research Brisbane

Albion, Queensland, 4010, Australia

Location

USC Clinical Trials

Sippy Downs, Queensland, 4556, Australia

Location

Related 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 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.

  PMID: 28012176 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

UE2343

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Miriam Roesner

  Actinogen Medical Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study treatment is blinded for participants, investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2021
• First Posted: July 30, 2021
• Study Start: June 30, 2021
• Primary Completion: February 11, 2022
• Study Completion: February 11, 2022
• Last Updated: January 23, 2025

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)