Clinical trial NCT05579236: Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
Official title: An Observational Longitudinal Cohort Study to Investigate Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Dementia
Keywords: Neurodegenerative Diseases
Diagnosis
Prognosis
Diagnostic Imaging
Neuroimaging
Magnetic Resonance Imaging
Diffusion Tensor Imaging
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Southampton
name: Oxford Brain Diagnostics Ltd
name: Cardiff and Vale University Health Board
name: Cardiff University
name: University of Oxford
name: Bournemouth University
First posted: 2022-10-13
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: CDR Progression
timeFrame: Baseline (Study day 1) to month 24
Secondary outcomes:
measure: CDR Sum of Boxes
timeFrame: Baseline (Study day 1) to month 24
measure: ADAS-cog
timeFrame: Baseline (Study day 1) to month 24
measure: MMSE
timeFrame: Baseline (Study day 1) to month 24
measure: ADCOMS
timeFrame: Baseline (Study day 1) to month 24
measure: RBANS
timeFrame: Baseline (Study day 1) to month 24
measure: ADCS-ADL
timeFrame: Baseline (Study day 1) to month 24
measure: Functional Activities Questionnaire (FAQ)
timeFrame: Baseline (Study day 1) to month 24
measure: Institutionalisation or POC
timeFrame: Baseline (Study day 1) to month 24
measure: Death (any cause)
timeFrame: Baseline (Study day 1) to month 24
measure: EQ-5D-5L (Patient Participant)
timeFrame: Baseline (Study day 1) to month 24
measure: EQ-5D-5L (Study Companion)
timeFrame: Baseline (Study day 1) to month 24
measure: Zarit Burden Interview
timeFrame: Baseline (Study day 1) to month 24
measure: Health and social care resource usage
timeFrame: Baseline (Study day 1) to month 24
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: Hampshire
city: Bournemouth
country: United Kingdom
facility: Dorset Healthcare University NHS Foundation Trust
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Health Board
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Christopher Kipps, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oxford Brain Diagnostics Ltd
name: Steven Chance, PhD
role: STUDY_CHAIR
References: