Alzheimer Disease Clinical Trial
— CONGAOfficial 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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | April 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Dorset Healthcare University NHS Foundation Trust | Bournemouth | |
United Kingdom | Cardiff and Vale University Health Board | Cardiff | |
United Kingdom | University Hospital Southampton NHS Foundation Trust | Southampton | Hampshire |
Lead Sponsor | Collaborator |
---|---|
University Hospital Southampton NHS Foundation Trust | Bournemouth University, Cardiff and Vale University Health Board, Cardiff University, Oxford Brain Diagnostics Ltd, University of Oxford, University of Southampton |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Death (any cause) | Death due to any cause | Baseline (Study day 1) to month 24 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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