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

Actinogen Medical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Alzheimer's Disease; Mild Cognitive Impairment

Treatments: Drug: Xanamem® 10 mg; Drug: Placebo; Drug: Xanamem® 5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04983368

ACW0005

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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107 participants in 3 patient groups, including a placebo group

Xanamem® 5 mg

Experimental group

Description:

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

Treatment:

Drug: Xanamem® 5 mg

Xanamem® 10 mg

Experimental group

Description:

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

Treatment:

Drug: Xanamem® 10 mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo