Cognitive Impairment and Affective Mood Disorders in Patients With IBD (COGN-IBD-1)

Iuliu Hatieganu University of Medicine and Pharmacy

Status: Enrolling

Conditions: Quality of Life; Mild Cognitive Impairment; Depression; Anxiety; Inflammatory Bowel Diseases; Stress

Treatments: Diagnostic Test: Cognitive testing

Study type: Observational

Funder types: Other

Identifiers

NCT05760729

4687/01.10.2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

75 participants in 2 patient groups

Inflammatory bowel disease patients

Description:

It is mandatory to have a certain diagnosis of IBD before the inclusion.

Treatment:

Diagnostic Test: Cognitive testing

Healthy controls

Description:

Patients who have never had the diagnosis of inflammatory bowel disease

Treatment:

Diagnostic Test: Cognitive testing