Mild Cognitive ImpairmentCONGANCT05579236
Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
An observational study of Mild Cognitive Impairment and Alzheimer Disease, run by University Hospital Southampton NHS Foundation Trust at 3 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease, Dementia
- How many people
- 400 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 28 Sep 2022to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 200 patient participants and 200 study companions will be recruited to the study. 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.
Who may be able to join
- 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
- 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
Who cannot join
- 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
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Dorset Healthcare University NHS Foundation Trust
Bournemouth
Cardiff and Vale University Health Board
Cardiff
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
About this study
Official title: An Observational Longitudinal Cohort Study to Investigate 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease, Dementia
- Keywords
- Neurodegenerative Diseases, Diagnosis, Prognosis, Diagnostic Imaging, Neuroimaging, Magnetic Resonance Imaging, Diffusion Tensor Imaging
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia, Neurodegenerative Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CDR Progression
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)
Measured: Baseline (Study day 1) to month 24
Secondary outcomes (13)
CDR Sum of Boxes
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.
Measured: Baseline (Study day 1) to month 24
ADAS-cog
Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog). Higher scores for ADAS-Cog represent a worse outcome.
Measured: Baseline (Study day 1) to month 24
MMSE
Change from baseline in Mini Mental State Examination (MMSE). MMSE ranges from 0 to 30, with lower scores representing a worse outcome.
Measured: Baseline (Study day 1) to month 24
ADCOMS
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.
Measured: Baseline (Study day 1) to month 24
RBANS
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.
Measured: Baseline (Study day 1) to month 24
ADCS-ADL
Change from baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Scale (ADCS-ADL). ADCS-ADL
Measured: Baseline (Study day 1) to month 24
Functional Activities Questionnaire (FAQ)
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.
Measured: Baseline (Study day 1) to month 24
Institutionalisation or POC
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.
Measured: Baseline (Study day 1) to month 24
Death (any cause)
Death due to any cause
Measured: Baseline (Study day 1) to month 24
EQ-5D-5L (Patient Participant)
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.
Measured: Baseline (Study day 1) to month 24
EQ-5D-5L (Study Companion)
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.
Measured: Baseline (Study day 1) to month 24
Zarit Burden Interview
The Zarit Burden Interview (ZBI) assesses caregiver perceptions of burden. Higher scores indicate a worse outcome.
Measured: Baseline (Study day 1) to month 24
Health and social care resource usage
Health and social care resource usage questionnaire. Higher values indicate a worse outcome.
Measured: Baseline (Study day 1) to month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start28 Sep 2022
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton, Oxford Brain Diagnostics Ltd, Cardiff and Vale University Health Board, Cardiff University, University of Oxford, Bournemouth University
- Responsible party
- Sponsor
- Investigators
- Christopher Kipps, PhD, Principal investigator, University Hospital Southampton NHS Foundation TrustSteven Chance, PhD, Study chair, Oxford Brain Diagnostics Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579236
- Sponsor's protocol ID
- RHM NEU0402
- Other IDs
- NIHR202146
- Acronym
- CONGA
- Status last verified
- Apr 2026
- First submitted
- 16 Sep 2022
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Longitudinal Cohort Study to Investigate Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05579236
- Acronym / sponsor ID
- CONGA / RHM NEU0402
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease, Dementia
- Keywords
- Neurodegenerative Diseases, Diagnosis, Prognosis, Diagnostic Imaging, Neuroimaging, Magnetic Resonance Imaging, Diffusion Tensor Imaging
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Southampton, Oxford Brain Diagnostics Ltd, Cardiff and Vale University Health Board, Cardiff University, University of Oxford, Bournemouth University
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 200 patient participants and 200 study companions will be recruited to the study. 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
13 secondary outcomes
CDR Sum of Boxes
Time frame: Baseline (Study day 1) to month 24
ADAS-cog
Time frame: Baseline (Study day 1) to month 24
MMSE
Time frame: Baseline (Study day 1) to month 24
ADCOMS
Time frame: Baseline (Study day 1) to month 24
RBANS
Time frame: Baseline (Study day 1) to month 24
ADCS-ADL
Time frame: Baseline (Study day 1) to month 24
Functional Activities Questionnaire (FAQ)
Time frame: Baseline (Study day 1) to month 24
Institutionalisation or POC
Time frame: Baseline (Study day 1) to month 24
Death (any cause)
Time frame: Baseline (Study day 1) to month 24
EQ-5D-5L (Patient Participant)
Time frame: Baseline (Study day 1) to month 24
EQ-5D-5L (Study Companion)
Time frame: Baseline (Study day 1) to month 24
Zarit Burden Interview
Time frame: Baseline (Study day 1) to month 24
Health and social care resource usage
Time frame: Baseline (Study day 1) to month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Kipps, PhD principal investigator
University Hospital Southampton NHS Foundation Trust
Steven Chance, PhD study chair
Oxford Brain Diagnostics Ltd
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Alzheimer Disease, run by University Hospital Southampton NHS Foundation Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CDR Progression (time frame: Baseline (Study day 1) to month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.