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Cognition and NeuroImaging in neuroDegenerative Disorders (CogNID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03861884
Recruitment Status : Unknown
Verified February 2019 by Nottingham University Hospitals NHS Trust.
Recruitment status was:  Recruiting
First Posted : March 4, 2019
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust

Study Description
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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.

Condition or disease Intervention/treatment
Dementia (Diagnosis) Diagnostic Test: Cognitive assessments

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 Design
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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognition and NeuroImaging in neuroDegenerative Disorders (CogNID)
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Cognitive assessments
Neurocognitive assessments, Birmingham Cognitive Screen
MRI at 3T
Brain Imaging: MRI at 3T
 Diagnostic Test: Cognitive assessments
Cognitive assessment and MRI at 3T and/or 7T
Other Names:
  • MRI at 3T
  • MRI at 7T
MRI at 7T
Brain imaging: Ultrahigh Field MRI at 7T
 Diagnostic Test: Cognitive assessments
Cognitive assessment and MRI at 3T and/or 7T
Other Names:
  • MRI at 3T
  • MRI at 7T


Outcome Measures
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Primary Outcome Measures :
  1. Neurocognitive scales on Birmingham Cognitive Screen (BCoS) Scores [ Time Frame: Through study completion (an average of one year) ]
    cognitive sub scores in relation to clinical phenotype


Secondary Outcome Measures :
  1. Structural imaging changes on MRI at 3T [ Time Frame: Through study completion (an average of one year) ]
    Structural volume loss

  2. Susceptibility weighted mapping at 7T [ Time Frame: Through study completion (an average of one year) ]
    Quantitative Susceptibility Mapping


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Alzheimer's disease, Frontotemporal dementia, Vascular Cognitive Impairment
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861884


Contacts
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Contact: Akram Dr Hosseini 0115 924 9924 ext 66410 Akram.Hosseini@nuh.nhs.uk
Contact: Pauline Hyman-Taylor 0115 924 9924 ext 60677 pauline.hyman-taylor@nuh.nhs.uk

Locations
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United Kingdom
Nottinghamshire Healthcare NHS Foundation Trust Not yet recruiting
Nottingham, Easat Midland, United Kingdom, NG7 2TU
Contact: Clare Litherland       Clare.Litherland@nottshc.nhs.uk   
Contact: Craig Beecroft       Craig.Beecroft@nottshc.nhs.uk   
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, East Midland, United Kingdom, NG7 2UH
Contact: Sara Wilkins       Sara.Wilkins@nuh.nhs.uk   
Contact: Julie Lynch       Julie.Lynch@nuh.nhs.uk   
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
Investigators
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Principal Investigator: Akram Hosseini, MD, PhD Akram.Hosseini@nuh.nhs.uk
More Information
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Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03861884    
Other Study ID Numbers: 18NS001
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders