Cognition and NeuroImaging in neuroDegenerative Disorders (CogNID)

March 20, 2024 updated by: Nottingham University Hospitals NHS Trust

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Easat Midland
      • Nottingham, Easat Midland, United Kingdom, NG7 2TU
        • Completed
        • Nottinghamshire Healthcare NHS Foundation Trust
    • East Midland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with Alzheimer's disease, Frontotemporal dementia, Vascular Cognitive Impairment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion (an average of one year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Structural imaging changes on MRI at 3T
Time Frame: Through study completion (an average of one year)
Structural volume loss
Through study completion (an average of one year)
Susceptibility weighted mapping at 7T
Time Frame: Through study completion (an average of one year)
Quantitative Susceptibility Mapping
Through study completion (an average of one year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham University Hospitals NHS Trust

Investigators

  • Principal Investigator: Akram Hosseini, MD, PhD, Akram.Hosseini@nuh.nhs.uk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2018

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

February 26, 2019

First Submitted That Met QC Criteria

March 1, 2019

First Posted (Actual)

March 4, 2019

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18NS001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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