CONGA: Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease

Sponsor
University Hospital Southampton NHS Foundation Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT05579236
Collaborator
University of Southampton (Other), Oxford Brain Diagnostics Ltd (Other), Cardiff and Vale University Health Board (Other), Cardiff University (Other), University of Oxford (Other), Bournemouth University (Other)
400
2
30.1
200
6.6

Study Details

Study Description

Brief Summary

The aim of this study is to find out whether a new image analysis technique called Cortical Disarray Measurement (CDM) could be used to help better diagnose Alzheimer's disease. This study will see whether changes on CDM can be used to identify Alzheimer's disease from a group of people living with memory and thinking problems. The study will also explore how CDM relates to changes in memory or thinking over time.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a multi-centre observational longitudinal cohort study to evaluate and optimise the Cortical Disarray Measurement (CDM) technique for diagnosis and prognosis in patients with mild cognitive impairment and prodromal / mild Alzheimer's Disease. CDM is a novel MRI analysis tool that quantifies cortical and regional diffusion tensor imaging signals in grey matter to observe pathological changes related to neurodegeneration. Participants in this study will be monitored for 2 years.

    Research Aims:
    • Assess the accuracy of CDM in detecting progressive change in cognitive and functional measures over 2 years in participants presenting with mild cognitive impairment or early dementia.

    • Determine the relationship between CDM (both cross-sectionally and longitudinally) and change on standard cognitive and functional assessment measures.

    • Explore patient and companion views and experiences of the diagnostic journey for dementia and their views on CDM implementation.

    • To explore the costs and consequences of introducing CDM-augmented MRI as a form of early diagnosis of Alzheimer's disease in people presenting with MCI or mild AD compared to current practice.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An Observational Longitudinal Cohort Study to Investigate Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
    Actual Study Start Date :
    Sep 28, 2022
    Anticipated Primary Completion Date :
    Apr 1, 2025
    Anticipated Study Completion Date :
    Apr 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Patient Participants

    Patient participants will have a diagnosis of mild cognitive impairment or prodromal / mild Alzheimer's Disease. Participants with a global CDR score of 0.5 and 1 will be recruited in a minimum of a 2:1 ratio respectively in the study.

    Study Companions

    Study companions will have sufficient knowledge on the patient participant's condition to complete companion assessments of the patient, in the investigator's judgement, for example they may be carers of the patients.

    Outcome Measures

    Primary Outcome Measures

    1. CDR Progression [Baseline (Study day 1) to month 24]

      CDR Progression defined as a binary variable (yes/no) indicating either an increase in global outcome on Clinical Dementia Rating (CDR) scale (which takes value 0, 0.5, 1, 2 or 3, with higher scores reflecting more severe dementia), or an increase greater than, or equal to, 2 points on CDR Sum of Boxes (which takes values from 0 to 18 with higher values indicating a worse outcome)

    Secondary Outcome Measures

    1. CDR Sum of Boxes [Baseline (Study day 1) to month 24]

      Change from baseline in the Clinical Dementia Rating (CDR) Sum of Boxes. CDR Sum of boxes is the sum over 6 domains (memory, orientation, judgment & problem solving, community affairs, home & hobbies, and personal care), each rated on a 5-point scale (0, 0.5, 1, 2, 3), giving a total score that ranges from 0 to 18, with higher values indicating a worse outcome.

    2. ADAS-cog [Baseline (Study day 1) to month 24]

      Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog). Higher scores for ADAS-Cog represent a worse outcome.

    3. MMSE [Baseline (Study day 1) to month 24]

      Change from baseline in Mini Mental State Examination (MMSE). MMSE ranges from 0 to 30, with lower scores representing a worse outcome.

    4. ADCOMS [Baseline (Study day 1) to month 24]

      Change from baseline in Alzheimer's disease composite score (ADCOMS). The range of ADCOMS is between 0 and 1.97, with higher scores representing a worse outcome.

    5. RBANS [Baseline (Study day 1) to month 24]

      Change from baseline in the RBANS total score. The repeatable battery for the assessment of neuropsychological status (RBANS) is a brief neuropsychological battery. The total score can classify patients as follows: Average/Mild Impairment (standard scores of 70 or above), Moderate Impairment (standard scores from 55 to 69), and Severe Impairment (standard scores <54), such that lower scores indicate a worse outcome.

    6. ADCS-ADL [Baseline (Study day 1) to month 24]

      Change from baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Scale (ADCS-ADL). ADCS-ADL

    7. Functional Activities Questionnaire (FAQ) [Baseline (Study day 1) to month 24]

      The Functional Activities Questionnaire (FAQ) measures instrumental activities of daily living. Scores range from 0 (independent) to 30 (dependent), with higher scores indicating a worse outcome.

    8. Institutionalisation or POC [Baseline (Study day 1) to month 24]

      Institutionalisation in care home or nursing home or implementation of package of care (POC) for dementia. Binary outcome (yes, no), with "yes" indicating a worse outcome.

    9. Death (any cause) [Baseline (Study day 1) to month 24]

      Death due to any cause

    10. EQ-5D-5L (Patient Participant) [Baseline (Study day 1) to month 24]

      EuroQuol EQ-5D-5L is an instrument to describe and value health on five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

    11. EQ-5D-5L (Study Companion) [Baseline (Study day 1) to month 24]

      EuroQuol EQ-5D-5L is an instrument to describe and value health on five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

    12. Zarit Burden Interview [Baseline (Study day 1) to month 24]

      The Zarit Burden Interview (ZBI) assesses caregiver perceptions of burden. Higher scores indicate a worse outcome.

    13. Health and social care resource usage [Baseline (Study day 1) to month 24]

      Health and social care resource usage questionnaire. Higher values indicate a worse outcome.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    PATIENT PARTICIPANTS

    Inclusion Criteria:
    • Diagnosis of mild cognitive impairment (MCI) or prodromal Alzheimer's Disease (AD) as defined by National Institute on Ageing/Alzheimer's Association (NIA/AA) diagnostic criteria for MCI/prodromal AD, NOT including MCI unlikely due to AD; OR, Diagnosis of Alzheimer's disease as defined by NIA/AA criteria for probable AD

    • Clinical dementia rating (CDR) scale global score of very mild or mild (0.5 or 1) impairment

    • Ability to undergo and tolerate MRI scans, with no contraindications to MRI

    • Ability to tolerate blood draws

    • Ability to give informed consent to participate in the study

    Exclusion Criteria:
    • Do not meet the inclusion criteria

    • No study companion available

    • Individuals with a non-progressive learning disability

    • Pregnant or intending to become pregnant during the study

    COMPANION PARTICIPANTS

    Inclusion Criteria:
    • Aged over 18 years

    • Sufficient knowledge on study participant's condition to complete companion assessments of the patient, in the investigator's judgement

    • Able and willing to attend all clinical visits for completion of companion assessments or provide the relevant assessments remotely via phone or video call

    Exclusion Criteria:
    • A condition or reason, in the investigator's judgement, that would question the validity of the acquired companion reported data

    • Individuals who are not fluent in English

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Southampton NHS Foundation Trust Southampton Hampshire United Kingdom SO16 6YD
    2 Cardiff and Vale University Health Board Cardiff United Kingdom

    Sponsors and Collaborators

    • University Hospital Southampton NHS Foundation Trust
    • University of Southampton
    • Oxford Brain Diagnostics Ltd
    • Cardiff and Vale University Health Board
    • Cardiff University
    • University of Oxford
    • Bournemouth University

    Investigators

    • Principal Investigator: Christopher Kipps, PhD, University Hospital Southampton NHS Foundation Trust
    • Study Chair: Steven Chance, PhD, Oxford Brain Diagnostics Ltd

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Southampton NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT05579236
    Other Study ID Numbers:
    • RHM NEU0402
    • NIHR202146
    First Posted:
    Oct 13, 2022
    Last Update Posted:
    Oct 13, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital Southampton NHS Foundation Trust
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 13, 2022