Cognitive Impairment and Affective Mood Disorders in Patients With IBD

Recruiting

• Conditions: Inflammatory Bowel Diseases; Depression; Mild Cognitive Impairment; Quality of Life; Anxiety; Stress
• Interventions: Diagnostic Test: Cognitive testing

• Registration Number: NCT05760729
• Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

Brief Summary

The aim is to evaluate the presence of mild cognitive impairment (MCI) in patients with inflammatory bowel disease (IBD). This will be done by cognitive tests. Along them, screening for depression, anxiety and stress will be done. A blood sample for determining serum values of homocysteine, protein S100-B, amyloid and BDNF will be stored. Patients will be followed-up for 2 years.

Detailed Description

The aim is to evaluate the presence of mild cognitive impairment (MCI) in patients with inflammatory bowel disease (IBD). This will be done by cognitive tests. Along them, screening for depression, anxiety and stress will be done. A blood sample for determining serum values of homocysteine, protein S100-B, amyloid and BDNF will be stored. Patients will be followed-up for 2 years.

Study has 3 phases: inclusion, 1 year visit and 2 year visit. Inclusion: consent signing, checking exclusion and inclusion criteria, cognitive testing, blood sample storing, questionnaires for screening.

1. year visit: cognitive testing.

2. year visit: cognitive testing.

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2023-02-23
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-06
• Last Update Submitted: 2023-03-06
• Study First Posted: 2023-03-08
• Last Update Posted: 2023-03-08
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Diagnosis of IBD for IBD group.
2. No diagnosis of IBD for healthy controls group.
3. Obtainment of signed informed consent.

Exclusion Criteria

1. No consent form signed.
2. Pregnancy.
3. Severe organ insufficiency (cardiac, renal, respiratory, liver).
4. Prior severe head trauma.
5. Neoplasia.
6. Prior neurodegenerative disease.
7. Prior diagnosis of cognitive impairment or dementia.
8. Prior cardiac arrest.
9. Use of B9 and B12 vitamin supplements.
10. Involvement in other clinical trials.
11. Unclear diagnosis.
12. Prior psychiatric disorders.
13. Prior use of neuroleptics.
14. Proven history of familiar Alzheimer disease.
15. Alcohol and drugs abuse.
16. Prior stroke.
17. Prior myocardial infarction.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inflammatory bowel disease patients	Cognitive testing	It is mandatory to have a certain diagnosis of IBD before the inclusion.
Healthy controls	Cognitive testing	Patients who have never had the diagnosis of inflammatory bowel disease

Primary Outcome Measures

Name	Time	Method
Trail Making Test B (TMT-B)	inclusion	Scored from 0-300 seconds
Serum S100-B protein	inclusion	ug/ml
Serum amyloid	inclusion	ug/ml
Montreal cognitive assessment score (MOCA)	2 years	MOCA has 0-30 points
Trail Making Test A (TMT-A)	inclusion	Scored from 0-100 seconds
Forward digit span testing	2 years	0-16 points
Digit symbol substitution test	inclusion	0-90 points
Backward digit span testing	2 years	0-14 points
Serum homocysteine	inclusion	mg/dl
Serum brain derived neurotrophic factor (BDNF)	inclusion	ug/ml

Secondary Outcome Measures

Name	Time	Method
Depression score	inclusion	0-42 points
Anxiety score	inclusion	0-42 points
Stress score	inclusion	0-42 points
Quality of life score	inclusion	0-100 points for each domain 4 domains: * Social relationships; * Environment; * Physical health; * Psychological

Trial Locations

Locations (3)

Oliviu Florențiu Sârb; 🇷🇴 Cluj-Napoca, Cluj, Romania

Spitalul Clinic CF Cluj-Napoca; 🇷🇴 Cluj-Napoca, Romania

Clinica de Hepatologie si Gastroenterologie "Digenio"; 🇷🇴 Cluj-Napoca, Romania