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NCT04490330 Clinical Trial

Screening for Alcohol-related Cognitive Impairments in Cirrhotic Patients

Cirrhosis Clinical Trial

— CirCo  

Official title:
Screening for Alcohol-related Cognitive Impairments in Cirrhotic Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04490330
Other study ID # PI2019_843_0106
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date August 2023

Study information
Verified date February 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Bernard ANGERVILLE, MD
Phone (33)322068297
Email angerville.bernard@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

80% of patients with alcohol use disorders (AUD) present cognitive impairments, such as memory and executive functions. These disorders may have repercussions in addiction treatment by altering the patient's adherence to care. The level of impairment is dependent on the onset of addiction, and also the duration of abstinence. A complete neuropsychological evaluation is necessary to highlight cognitive impairments. In practice, the evaluation of these disorders by practitioners, is done with the help of tools of screening like the MoCa (Montreal cognitive assesment) and the BEARNI (Brief evaluation of alcohol related neuropsychological impairment). However, none of these tools have been evaluated in patients with alcoholic cirrhosis. Indeed, some studies have suggested that liver disorders including cirrhosis may be a factor aggravating cognitive disorders. The purpose of this study is to evaluate the ability of the BEARNI tool to detect alcohol-related cognitive problems in patients with alcohol-related cirrhosis.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date August 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with cirrhosis - patients with cirrhosis diagnosed by clinical examination - patients with cirrhosis diagnosed by biological and / or morphological and / or noninvasive tests and / or liver biopsy - CHILD A, B or C Exclusion Criteria: - hepatitis encephalopathy less than 6 months old - complicated cirrhosis with hepatocellular carcinoma - Acute alcoholic hepatitis - viral cirrhosis

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• questionnaire
AUDIT questionnaire (alcohol use disorders identification test)

Locations
Country Name City State
France CHU Amiens Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of alcoholic cirrhosis patients with presence of alcohol-related cognitive disorders the number of alcoholic cirrhosis patients with presence of alcohol-related cognitive disorders will be measured by using the BEARNI screening tool. BEARNI screening tool is Brief evaluation of alcohol related neuropsychological impairment. day 1
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