An Observational Longitudinal Cohort Study to Investigate Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 400
- Locations
- 6
- Primary Endpoint
- CDR Progression
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Outcomes
Primary Outcomes
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
- EQ-5D-5L (Study Companion)(Baseline (Study day 1) to month 24)
- Zarit Burden Interview(Baseline (Study day 1) to month 24)
- Health and social care resource usage(Baseline (Study day 1) to month 24)
- ADCOMS(Baseline (Study day 1) to month 24)
- EQ-5D-5L (Patient Participant)(Baseline (Study day 1) to month 24)
- MMSE(Baseline (Study day 1) to month 24)
- RBANS(Baseline (Study day 1) to month 24)
- CDR Sum of Boxes(Baseline (Study day 1) to month 24)
- ADAS-cog(Baseline (Study day 1) to month 24)
- ADCS-ADL(Baseline (Study day 1) to month 24)
- Functional Activities Questionnaire (FAQ)(Baseline (Study day 1) to month 24)
- Institutionalisation or POC(Baseline (Study day 1) to month 24)
- Death (any cause)(Baseline (Study day 1) to month 24)