A study to assess adverse events, change in disease activity and how oral ABBV-552 capsules moves through the body of participants aged 50 to 90 years with mild Alzheimer's disease
Information about the drug that will be tested in the study
Administration
Oral capsules once daily
Is the drug already on the market for another medical condition?
No
Will all participants receive the same drug?
Participants will be selected at random to either receive one of the following options:
- A capsule of ABBV-552
- A capsule of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect)
Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.
Information about participating in the trial
What are the researchers trying to find out?
The purpose of the study is to evaluate the safety and efficacy of ABBV-552 in people with mild Alzheimer’s disease
How long will the treatment last?
The treatment lasts 12 weeks and participants will then be followed for 4 weeks
What your involvement will entail?
Participants will be asked to complete a test that will assess their cognitive impairments (this is a test called ADAS-Cog 14)
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Be between 50 and 90 years old
- Have a diagnosis of probable Alzheimer’s disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) (2011) criteria
- Have a score between 20-26 points in the MMSE test (a test about a range of everyday mental skills) and a score of 0.5 to 1 in the Clinical Dementia Rating-Global Score (CDR)
Who cannot participate in the study?
People cannot take part in the study if they have or have experienced:
Clinically significant and/or an unstable medical condition that may interfere with the safety, tolerability and/or study assessments (e.g., unlikely to adhere to the study or procedures, keep appointments, or is planning to relocate during the study) or would make the participant an unsuitable candidate to receive ABBV-552
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
EudraCT Number
2022-501918-55-00
Clinicaltrials.gov identifier
NCT05771428
Study contact information
abbvieclinicaltrials@abbvie.com
Link to full text
https://clinicaltrials.gov/study/NCT05771428
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on November 2023.
This document has been reviewed by a member of the European Dementia Carers Working Group.
