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Cognitive Impairment and Affective Mood Disorders in Patients With IBD

Cognitive Impairment and Affective Mood Disorders in Patients With IBD

Non Recruiting
18-75 years
All
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    Inflammatory Bowel Diseases
    Mild Cognitive Impairment
    Depression
    Anxiety
    Stress
    Quality of Life

NCT05760729

Iuliu Hatieganu University of Medicine and Pharmacy

20 August 2025

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