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NCT Number: NCT05579236

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

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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Disease Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. CDR Progression

    Time frame: 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 outcomes

  1. CDR Sum of Boxes

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: Baseline (Study day 1) to month 24

    Death due to any cause

  10. EQ-5D-5L (Patient Participant)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: Baseline (Study day 1) to month 24

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

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Collaborators

  • Bournemouth University
  • Cardiff University
  • Cardiff and Vale University Health Board
  • Oxford Brain Diagnostics Ltd
  • University of Oxford
  • University of Southampton

Registry information

Official study title

An Observational Longitudinal Cohort Study to Investigate Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease

Acronym: CONGA

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 13, 2022
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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