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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05760729
Other study ID # 4687/01.10.2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date May 30, 2025

Study information

Verified date March 2023
Source Iuliu Hatieganu University of Medicine and Pharmacy
Contact Oliviu Floren?iu Sârb, MD
Phone +40728027542
Email sarboliviu@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date May 30, 2025
Est. primary completion date May 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
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 Design


Intervention

Diagnostic Test:
Cognitive testing
Cognitive tests will be carried: MOCA, trail making test, digit symbol substitution, forward and backward digit testing.

Locations

Country Name City State
Romania Clinica de Hepatologie si Gastroenterologie "Digenio" Cluj-Napoca
Romania Oliviu Floren?iu Sârb Cluj-Napoca Cluj
Romania Spitalul Clinic CF Cluj-Napoca Cluj-Napoca

Sponsors (1)

Lead Sponsor Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Montreal cognitive assessment score (MOCA) MOCA has 0-30 points inclusion
Primary Trail Making Test A (TMT-A) Scored from 0-100 seconds inclusion
Primary Trail Making Test B (TMT-B) Scored from 0-300 seconds inclusion
Primary Digit symbol substitution test 0-90 points inclusion
Primary Forward digit span testing 0-16 points inclusion
Primary Forward digit span testing 0-16 points 1 year
Primary Forward digit span testing 0-16 points 2 years
Primary Backward digit span testing 0-14 points inclusion
Primary Backward digit span testing 0-14 points 1 year
Primary Backward digit span testing 0-14 points 2 years
Primary Serum homocysteine mg/dl inclusion
Primary Serum brain derived neurotrophic factor (BDNF) ug/ml inclusion
Primary Serum S100-B protein ug/ml inclusion
Primary Serum amyloid ug/ml inclusion
Primary Montreal cognitive assessment score (MOCA) MOCA has 0-30 points 1 year
Primary Montreal cognitive assessment score (MOCA) MOCA has 0-30 points 2 years
Secondary Depression score 0-42 points inclusion
Secondary Quality of life score 0-100 points for each domain 4 domains:
Social relationships
Environment
Physical health
Psychological
inclusion
Secondary Stress score 0-42 points inclusion
Secondary Anxiety score 0-42 points inclusion
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