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Study on the Effects of ABBV-552 in Patients Aged 50-90 with Mild Alzheimer's Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying mild Alzheimer's disease, a condition that affects memory and thinking skills. The study will use a treatment called ABBV-552, which is taken as a capsule. The purpose of the study is to evaluate the safety and effectiveness of ABBV-552 in people with mild Alzheimer's disease. Participants will be randomly assigned to receive either the ABBV-552 capsule or a placebo, which looks like the treatment but does not contain the active substance.

The study will last for about 12 weeks, during which participants will take the capsule once a day. Researchers will monitor how the treatment affects the body and any changes in the disease's activity. The main focus will be on changes in cognitive abilities, which are measured using a specific test designed for Alzheimer's disease. This will help determine if ABBV-552 can improve or stabilize memory and thinking skills in participants.

Participants in the study will be between 50 and 90 years old and have a diagnosis of probable Alzheimer's disease. The study aims to provide valuable information on how ABBV-552 works in the body and its potential benefits for people with mild Alzheimer's disease. The results could lead to new insights into managing this condition and improving the quality of life for those affected.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be randomly assigned to receive either the study medication, ABBV-552, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.
Step 2
Medication administration
Participants will take the assigned medication orally in the form of a capsule. The dosage will be determined by the study team and could be 1mg, 5mg, or 10mg of ABBV-552 or a matching placebo.
The medication is to be taken once daily for the duration of the study.
Step 3
Study duration
The study is designed to last for approximately 12 weeks. During this time, participants will be required to attend regular study visits as scheduled by the research team.
Step 4
Assessments and evaluations
Throughout the study, participants will undergo various assessments to evaluate the effects of the medication. This includes cognitive tests such as the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14), which measures changes in memory and thinking abilities.
These assessments will help determine the safety and effectiveness of ABBV-552 in treating mild Alzheimer's disease.
Step 5
Completion of the study
At the end of the 12-week period, participants will have a final evaluation to assess any changes in their condition and to gather data on the medication's impact.
Participants will be informed about the next steps and any follow-up procedures if necessary.

Who can join the trial?

6 criteria

Participants must be between 50 and 90 years old.
Participants must have a diagnosis of probable Alzheimer's disease according to specific criteria set by the National Institute of Aging-Alzheimer's Association (NIA-AA) from 2011.
Participants need to have a Mini-Mental State Examination (MMSE) score between 20 and 26. This is a test that helps measure memory and thinking abilities.
Participants should have a Clinical Dementia Rating (CDR) global score of 0.5 or 1.0. This score helps assess the severity of dementia.
Participants must have a CDR memory score of 0.5 or higher. This score evaluates memory function.
Participants need to have at least one CDR functional domain score (community affairs, home and hobbies, or personal care) of 0.5 or higher. This assesses how well they manage daily activities.

Who cannot join the trial?

7 criteria

Patients with any other type of dementia besides mild Alzheimer's disease cannot participate. Dementia is a condition that affects memory and thinking.
Patients who have a history of severe allergic reactions to medications are excluded. An allergic reaction is when the body reacts badly to something, like a rash or trouble breathing.
Patients with serious medical conditions that could interfere with the study, such as severe heart, liver, or kidney disease, are not allowed. These are important organs in the body that help it work properly.
Patients who are currently participating in another clinical trial are not eligible. A clinical trial is a research study to test new treatments.
Patients who have used certain medications that might affect the study results within a specific time frame before the study starts are excluded. Some medications can change how the body responds to new treatments.
Patients with a history of drug or alcohol abuse within the past year cannot join. Abuse means using too much of a substance in a way that is harmful.
Patients who are unable to follow the study procedures or attend study visits are not eligible. Study procedures are the steps and tests done during the research.

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Verified sites

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Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Responsive
Hospital Ruber Internacional
Madrid, Spain
Responsive
Katholisches Klinikum Bochum gGmbH
Bochum, Germany

Trial locations

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Investigated drugs

ABBV-552 is a medication being studied for its potential to help people with mild Alzheimer's disease. Alzheimer's disease is a condition that affects the brain and can lead to memory loss and other cognitive difficulties. The purpose of this medication is to see if it can improve symptoms or slow down the progression of the disease. In this clinical trial, researchers are looking at how safe the medication is for patients, how well it works, and how the body processes it. They are also studying how the medication affects the brain and its functions. Participants in the trial take this medication once a day, and the study is designed to find the best dose that provides the most benefit with the fewest side effects.

(4R)-1-[(5-Chloro-1H-1,2,4-Triazol-1-Yl)Methyl]-4-(3,4,5-Trifluorophenyl)-2-Pyrrolidinone

What is already known about the treatment

ABBV-552 – ABBV-552 is administered orally in the form of a tablet and is currently being studied in clinical trials for its potential use in treating mild Alzheimer's disease. This medication is still under investigation, and its effectiveness and safety are being evaluated in medical research. The main therapeutic indication for ABBV-552 is to help manage symptoms associated with mild Alzheimer's disease. At the molecular level, ABBV-552 is believed to work by modulating certain brain receptors to improve cognitive function. It is classified pharmacologically as a neuropsychiatric agent.

Investigated diseases

Mild Alzheimer's disease – Mild Alzheimer's disease is a neurodegenerative condition characterized by gradual memory loss and cognitive decline. It primarily affects older adults and is the early stage of Alzheimer's disease. Individuals may experience difficulty remembering recent events, managing finances, or organizing tasks. Language problems, such as finding the right words, and slight changes in personality or mood can also occur. As the disease progresses, these symptoms become more pronounced, affecting daily life and independence. The progression is typically slow, with symptoms worsening over time.