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

University Hospital Southampton NHS Foundation Trust

Status: Enrolling

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Dementia

Study type: Observational

Funder types: Other

Identifiers

NCT05579236

NIHR202146 (Other Grant/Funding Number)

RHM NEU0402

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

400 participants in 2 patient groups

Patient Participants

Description:

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

Description:

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.