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

Investigating an Antibody Treatment for Early Alzheimer's Disease

Recruiting
50 years - 90 years
All
Phase 3
1 Location

Brief description of study.

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.

Detailed description of study

 

Eligibility of study

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

  • Conditions: ,Alzheimer's,Early Alzheimer's Disease,amyloid,mild cognitive impairment,Alzheimer's disease,amyloid therapy
  • Age: 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.

Updated on 19 Feb 2024. Study ID: 1903099114

This study investigates an investigational medication for people with early Alzheimer's Disease (AD), which includes mild cognitive impairment or mild dementia. AD is marked by a build-up of an abnormal protein called amyloid in the brain, which can affect memory and thinking. The investigational medication is a monoclonal antibody, meaning it is a protein made by the immune system to bind to foreign substances called antigens. This study aims to see if the investigational medication can reduce amyloid in the brain and improve symptoms in patients with early AD.

Participants will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will assess safety by monitoring for any side effects and will evaluate efficacy by measuring changes in symptoms and amyloid levels in the brain.

  • Who can participate: The study is open to male and female participants aged 50 to 90. Participants must have a Mini-Mental State Examination (MMSE) score of 22 or higher and a body mass index (BMI) between 17 and 35. They must also have a study partner who can provide support and information during the study.
  • Study details: Participants will be divided into study arms to receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. Participants will be monitored for safety and changes in symptoms and amyloid levels.

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