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| ID | Type | Description | Link |
|---|---|---|---|
| NIHR202146 | Other Grant/Funding Number | National Institute for Health Research |
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| Name | Class |
|---|---|
| University of Southampton | OTHER |
| Oxford Brain Diagnostics Ltd | UNKNOWN |
| Cardiff and Vale University Health Board | OTHER_GOV |
| Cardiff University |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline (Study day 1) to month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Study day 1) to month 24 |
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PATIENT PARTICIPANTS
Inclusion Criteria:
Exclusion Criteria:
COMPANION PARTICIPANTS
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Kipps, PhD | University Hospital Southampton NHS Foundation Trust | Principal Investigator |
| Steven Chance, PhD | Oxford Brain Diagnostics Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Southampton NHS Foundation Trust | Southampton | Hampshire | SO16 6YD | United Kingdom | ||
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D019636 | Neurodegenerative Diseases |
| D004194 | Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
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| OTHER |
| University of Oxford | OTHER |
| Bournemouth University | OTHER |
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Participants recruited will be invited to join a biosample repository substudy. This is an optional component to the main study that involves the collection and storage of biosamples for analysis of potential biomarkers of Alzheimer's disease and neurodegeneration, to aid validation of the CDM technique, and for future health research.
| ADAS-cog | Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog). Higher scores for ADAS-Cog represent a worse outcome. | 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. | 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. | 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. | 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 | 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. | 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. | Baseline (Study day 1) to month 24 |
| Death (any cause) | Death due to any cause | 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. | 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. | 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. | 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. | Baseline (Study day 1) to month 24 |
| Dorset Healthcare University NHS Foundation Trust |
| Bournemouth |
| United Kingdom |
| Cardiff and Vale University Health Board | Cardiff | United Kingdom |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |