Cognition and NeuroImaging in neuroDegenerative Disorders (CogNID)

NCT ID: NCT03861884

Last Updated: 2024-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-12

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Dementia (Diagnosis)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cognitive assessments

Neurocognitive assessments, Birmingham Cognitive Screen

No interventions assigned to this group

MRI at 3T

Brain Imaging: MRI at 3T

Cognitive assessments

Intervention Type DIAGNOSTIC_TEST

Cognitive assessment and MRI at 3T and/or 7T

MRI at 7T

Brain imaging: Ultrahigh Field MRI at 7T

Cognitive assessments

Intervention Type DIAGNOSTIC_TEST

Cognitive assessment and MRI at 3T and/or 7T

Interventions

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Cognitive assessments

Cognitive assessment and MRI at 3T and/or 7T

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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MRI at 3T MRI at 7T

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Akram Hosseini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Nottinghamshire Healthcare NHS Foundation Trust

Nottingham, Easat Midland, United Kingdom

Site Status COMPLETED

Nottingham University Hospitals NHS Trust

Nottingham, East Midland, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Akram Dr Hosseini

Role: CONTACT

0115 924 9924 ext. 66410

Pauline Hyman-Taylor

Role: CONTACT

0115 924 9924 ext. 60677

Facility Contacts

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Haley Morris

Role: primary

Julie Lynch

Role: backup

Other Identifiers

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18NS001

Identifier Type: -

Identifier Source: org_study_id

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