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

A clinical trial is underway to assess the potential of ABBV-552, a new drug developed for treating mild Alzheimer’s disease. This study aims to evaluate the safety, effectiveness, and how the body processes ABBV-552 in patients aged 50 to 90 years. The trial involves a randomized, double-blind, placebo-controlled design to thoroughly investigate the drug’s impact on cognitive function and overall disease progression in individuals with mild Alzheimer’s disease.

Table of Contents

What is ABBV-552?

ABBV-552 is a new medication being developed to treat mild Alzheimer’s disease. It is currently undergoing clinical trials to evaluate its safety and effectiveness. The active ingredient in ABBV-552 is a chemical compound with a long scientific name: (4R)-1-[(5-CHLORO-1H-1,2,4-TRIAZOL-1-YL)METHYL]-4-(3,4,5-TRIFLUOROPHENYL)-2-PYRROLIDINONE.[1]

How Does ABBV-552 Work?

While the exact mechanism of action is not fully described in the available information, ABBV-552 is being studied for its potential to improve cognitive function in people with mild Alzheimer’s disease. The medication is taken orally as a capsule once daily, which means it’s designed to be easy for patients to take at home.[1]

Clinical Trial Details

A clinical trial is currently underway to study ABBV-552. The main goal of this trial is to evaluate the safety, effectiveness, and how the drug moves through and affects the body (known as pharmacokinetics and pharmacodynamics) in people with mild Alzheimer’s disease.[1]

The primary focus of the study is to measure changes in cognitive function using a test called the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14). This test helps researchers understand if the medication is improving thinking and memory skills in participants.[1]

Who Can Participate in the Study?

The study is looking for participants who meet the following criteria:

  • Age between 50 and 90 years old
  • Diagnosed with probable Alzheimer’s disease according to specific medical criteria
  • Score between 20 and 26 on the Mini-Mental State Examination (MMSE), which is a test used to measure cognitive impairment
  • Have a Clinical Dementia Rating (CDR) global score of 0.5 or 1.0, indicating very mild or mild dementia

These criteria help ensure that the study includes people who are in the early stages of Alzheimer’s disease and are most likely to benefit from the treatment.[1]

Study Design

The clinical trial is designed in three main phases:

  1. Screening Period: This lasts about 30 days and involves various tests to determine if a person is eligible to participate in the study. No medication is given during this time.[1]
  2. Double-Blind Treatment Period: This is the main part of the study, lasting 12 weeks. Participants are randomly assigned to receive either ABBV-552 (at one of three different doses) or a placebo (a pill that looks the same but contains no active medication). Neither the participants nor the researchers know who is receiving which treatment, which helps ensure unbiased results.[1]
  3. Safety Follow-Up Period: After the treatment period, there’s a 30-day follow-up period to monitor for any lasting effects or side effects of the medication.[1]

Potential Benefits and Risks

As with any new medication, ABBV-552 may offer potential benefits but also carries possible risks. The study is designed to carefully evaluate both. Potential benefits could include improvements in cognitive function for people with mild Alzheimer’s disease. However, as this is an investigational drug, all possible side effects are not yet known.[1]

It’s important to note that participation in clinical trials is voluntary, and participants can withdraw at any time. The study team closely monitors all participants for any adverse effects and provides ongoing care throughout the trial.[1]

Aspect Details
Drug Name ABBV-552
Active Substance (4R)-1-[(5-Chloro-1H-1,2,4-Triazol-1-Yl)Methyl]-4-(3,4,5-Trifluorophenyl)-2-Pyrrolidinone
Condition Studied Mild Alzheimer’s Disease
Study Design Randomized, Double-blind, Placebo-controlled, Dose-finding
Study Duration 12 weeks of treatment + 30 days follow-up
Participant Age Range 50-90 years
Primary Endpoint Change in ADAS-Cog 14 score at Week 12
Drug Administration Oral capsules, once daily
Maximum Daily Dose 15 mg

FAQ

  • What is ABBV-552? ABBV-552 is a new drug being studied for the treatment of mild Alzheimer's disease. Its active ingredient is (4R)-1-[(5-Chloro-1H-1,2,4-Triazol-1-Yl)Methyl]-4-(3,4,5-Trifluorophenyl)-2-Pyrrolidinone, which is being tested in capsule form for oral administration.
  • Who can participate in this clinical trial? The trial is open to participants between 50 and 90 years of age who have been diagnosed with probable Alzheimer's disease according to specific criteria. They must have a Mini-Mental State Examination (MMSE) score of 20 to 26 and meet certain other cognitive and functional requirements.
  • How long does the trial last? The trial consists of a 30-day screening period, followed by a 12-week double-blind treatment period, and a 30-day safety follow-up period. In total, participants will be involved for approximately 17 weeks.
  • What is the main goal of this clinical trial? The main objective of this trial is to evaluate the safety, efficacy, pharmacokinetics (how the body processes the drug), and pharmacodynamics (how the drug affects the body) of ABBV-552 when taken once daily for treating dementia due to mild Alzheimer's disease.
  • How is the effectiveness of ABBV-552 measured in this trial? The primary measure of effectiveness is the change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) score at Week 12. This scale helps assess cognitive function in people with Alzheimer's disease.

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

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

    Not recruiting

    2 1
    Investigated drugs:
    Germany Spain

Glossary

  • Alzheimer's Disease: A progressive brain disorder that slowly destroys memory and thinking skills, eventually affecting the ability to carry out simple tasks.
  • ABBV-552: The experimental drug being tested in this clinical trial for the treatment of mild Alzheimer's disease.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics (PD): The study of how a drug affects the body, including its mechanism of action and relationship between drug concentration and effect.
  • Mini-Mental State Examination (MMSE): A widely used test of cognitive function among older adults, used to screen for dementia and to estimate the severity of cognitive impairment.
  • Clinical Dementia Rating (CDR): A numeric scale used to quantify the severity of symptoms of dementia.
  • Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14): A test used to measure cognitive function in Alzheimer's disease patients, often used in clinical trials to assess the effectiveness of treatments.
  • Double-blind: A study design where neither the participants nor the researchers know who is receiving the actual treatment and who is receiving a placebo.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs.
  • Randomized: A method of assigning participants to different treatment groups by chance, to reduce bias in the study results.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-abbv-552-in-patients-aged-50-90-with-mild-alzheimers-disease/