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

Sponsor
Actinogen Medical (Industry)
Overall Status
Completed
CT.gov ID
NCT04983368
Collaborator
Avance Clinical (Other)
107
5
3
7.4
21.4
2.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Xanamem® 5 mg
  • Drug: Placebo
  • Drug: Xanamem® 10 mg
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
107 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Study treatment is blinded for participants, investigators.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 30, 2021
Actual Primary Completion Date :
Feb 11, 2022
Actual Study Completion Date :
Feb 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Xanamem® 5 mg

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

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

Experimental: Xanamem® 10 mg

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

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

Placebo Comparator: Placebo

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  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)]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Paratus Clinical Research Canberra Bruce Australian Capital Territory Australia 2617
2 Paratus Clinical Research Western Sydney Blacktown New South Wales Australia 2148
3 Paratus Clinical Research Central Coast Kanwal New South Wales Australia 2259
4 Paratus Clinical Research Brisbane Albion Queensland Australia 4010
5 USC Clinical Trials Sippy Downs Queensland Australia 4556

Sponsors and Collaborators

  • Actinogen Medical
  • Avance Clinical

Investigators

  • Study Director: Miriam Roesner, Actinogen Medical Limited

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Actinogen Medical
ClinicalTrials.gov Identifier:
NCT04983368
Other Study ID Numbers:
  • ACW0005
First Posted:
Jul 30, 2021
Last Update Posted:
Apr 8, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Actinogen Medical
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022