Cognition and NeuroImaging in neuroDegenerative Disorders (CogNID)

Recruiting

• Conditions: Dementia (Diagnosis)

• Registration Number: NCT03861884
• Lead Sponsor: Nottingham University Hospitals NHS Trust

Brief Summary

This prospective study aims:

1. to compare cognitive performance in different clinical groups of participants with mild cognitive impairment (MCI) or mild dementia \[Alzheimer's Disease (AD), Vascular Cognitive Impairment (VCI) and Fronto-temporal Dementia (FTD)\] to determine whether scores reveal differential profiles between the groups,

2. to demonstrate differences in imaging markers between different dementia syndromes and healthy volunteers using ultra high-field MRI at 7T.

Detailed Description

The imaging arm of the study include:

1. to demonstrate differences in brain iron levels between different dementia syndromes and healthy volunteers using ultra high-field MRI, quantitative susceptibility mapping (QSM) at 7T.

2. to demonstrate variations in the resting oxygen usage as an important biomarker to discriminate between different dementia syndromes.

3. to demonstrate cerebral blood flow changes in the brain, particularly in the hippocampus region, and its correlation with different dementia syndromes using Arterial Spin Labelling MRI technique.

4. to demonstrate increased blood brain barrier leakage in the brain, particularly in the hippocampus region, and its correlation with Alzheimer's Disease (AD) and Vascular Cognitive Impairment (VCI) using a new dynamic contrast-enhanced MRI (DCE-MRI) technique.

Study Timeline

• Study Start: 2018-12-12
• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

1. Ability to give informed consent.
2. Either pathological, genetic or imaging biomarker evidence to suggest Fronto-temporal Lobar Degeneration, Alzheimer's Disease or Vascular Cognitive Impairment, or defined clinical diagnoses.

Exclusion Criteria

1. Lack of mental capacity to consent to study involvement.
2. Not speaking English before age 5 years.
3. Learning disability.
4. MRI contraindications

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurocognitive scales on Birmingham Cognitive Screen (BCoS) Scores	Through study completion (an average of one year)	cognitive sub scores in relation to clinical phenotype

Secondary Outcome Measures

Name	Time	Method
Structural imaging changes on MRI at 3T	Through study completion (an average of one year)	Structural volume loss
Susceptibility weighted mapping at 7T	Through study completion (an average of one year)	Quantitative Susceptibility Mapping

Trial Locations

Locations (2)

Nottinghamshire Healthcare NHS Foundation Trust; 🇬🇧 Nottingham, Easat Midland, United Kingdom

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, East Midland, United Kingdom