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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2022-02-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Mild Cognitive Impairment Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study treatment is blinded for participants, investigators.

Study Groups

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Xanamem® 5 mg

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

Group Type EXPERIMENTAL

Xanamem® 5 mg

Intervention Type DRUG

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

Xanamem® 10 mg

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

Group Type EXPERIMENTAL

Xanamem® 10 mg

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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Xanamem® 5 mg

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

Intervention Type 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.

Intervention Type DRUG

Xanamem® 10 mg

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes