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

Alzheimer Disease Clinical Trial

— CONGA  

Official title:

An Observational Longitudinal Cohort Study to Investigate Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05579236
• Other study ID #: RHM NEU0402
• Secondary ID: NIHR202146
• Status: Recruiting
• Start date: September 28, 2022
• Est. completion date: April 2025

Study information

• Verified date: May 2023
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: Angus Prosser, PhD
• Phone: +44(0)2381206132
• Email: angus.prosser[@]soton.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Locations

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

Sponsors (7)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

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