A Study to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

J
Jared Brosch, MD

Primary Investigator

Overview

BAN2401 is an investigational study drug which is being studied in people who have early AD (Alzheimer's disease), with mild cognitive (thinking) impairment or mild dementia. People with AD have a build-up of abnormal protein known as amyloid in their brains.  This build up may lead to impairment in memory or thinking.  
BAN2401 is a monoclonal (single) antibody.  Antibodies are proteins produced by the immune system that bind to foreign substances in the body called antigens.  BAN2401 binds to amyloid in the brain in patients with AD and has been shown to reduce the amount of this abnormal protein.   
The purpose of this study is to assess the safety (symptoms and medical problems you may experience - known as side effects) and efficacy (how much the study drug improves symptoms and reduces amyloid in the brain) of the study drug in patients who have early AD.
 
There have been three studies of BAN2401.  About 688 subjects with AD have been treated with BAN2401 so far.

Description

 

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Early Alzheimer's Disease,Alzheimer's disease,mild cognitive impairment,Alzheimer's,amyloid,amyloid therapy,,alzheimers,alzheimers disease
  • Age: Between 50 Years - 90 Years
  • Gender: All

Inclusion Criteria includes: 
Male or female subjects aged 50-90
MMSE score greater than or equal to 22
Body mass index (BMI) greater than 17 and less than 35 at Screening.
Have an identified study partner (defined as a person able to support the subject for the duration of the study and who spends at least 8 hours per week with the subject). The study partner must provide separate written informed consent. In addition, this person must be willing and able to provide follow-up information on the subject throughout the course of the study. 
Exclusion Criteria includes: 
1. Females who are breastfeeding or pregnant
2. Females of childbearing potential who:
-Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
-total abstinence (if it is their preferred and usual lifestyle)
-an intrauterine device or intrauterine hormone-releasing system (IUS)
-a contraceptive implant
-an oral contraceptive (with additional barrier method) (Subject must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation.)
-have a vasectomized partner with confirmed azoospermia
-do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation
-for sites outside of the EU, it is permissible that if a highly effective method of contraception is not appropriate or acceptable method of contraception, ie, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical/vault cap with spermicide
3. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the subject's AD.
4. History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening.
5. Any psychiatric diagnosis or symptoms, (eg, hallucinations, major depression, or delusions) that could interfere with study procedures in the subject.
6. GDS score greater than or equal to 8 at Screening.
Additional Information:

Updated on 12 Jan 2024. Study ID: 1903099114

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

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