Clinical trial NCT03861884: Cognition and NeuroImaging in neuroDegenerative Disorders (CogNID)
Official title: Cognition and NeuroImaging in neuroDegenerative Disorders (CogNID)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dementia (Diagnosis)
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Alzheimer's disease, Frontotemporal dementia, Vascular Cognitive Impairment

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neurocognitive scales on Birmingham Cognitive Screen (BCoS) Scores
timeFrame: Through study completion (an average of one year)
Secondary outcomes:
measure: Structural imaging changes on MRI at 3T
timeFrame: Through study completion (an average of one year)
measure: Susceptibility weighted mapping at 7T
timeFrame: Through study completion (an average of one year)
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottinghamshire Healthcare NHS Foundation Trust
state: Easat Midland
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: East Midland
Study officials:
affiliation: Akram.Hosseini@nuh.nhs.uk
name: Akram Hosseini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: