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

NCT05579236 | Unknown

• 2 other identifiers: RHM NEU0402NIHR202146
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease; Dementia

Keywords

Neurodegenerative Diseases; Diagnosis; Prognosis; Diagnostic Imaging; Neuroimaging; Magnetic Resonance Imaging; Diffusion Tensor Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• CDR Sum of Boxes

  Baseline (Study day 1) to month 24

• ADAS-cog

  Baseline (Study day 1) to month 24

• MMSE

  Baseline (Study day 1) to month 24

• ADCOMS

  Baseline (Study day 1) to month 24

• RBANS

  Baseline (Study day 1) to month 24

Study Arms (2)

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.

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• No study companion available
• Individuals with a non-progressive learning disability
• Pregnant or intending to become pregnant during the study
• COMPANION PARTICIPANTS
• 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
• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• University of Southampton: collaborator
• Oxford Brain Diagnostics Ltd: collaborator
• Cardiff and Vale University Health Board: collaborator
• Cardiff University: collaborator
• University of Oxford: collaborator
• Bournemouth University: collaborator

Study Sites (3)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

Dorset Healthcare University NHS Foundation Trust

Bournemouth, United Kingdom

NOT YET RECRUITING

Cardiff and Vale University Health Board

Cardiff, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Dementia; Neurodegenerative Diseases; Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Kipps, PhD

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Steven Chance, PhD

  Oxford Brain Diagnostics Ltd

  STUDY CHAIR

Central Study Contacts

Angus Prosser, PhD

CONTACT

+44(0)2381206132; angus.prosser@soton.ac.uk

Christopher Kipps, MBBS, PhD

CONTACT

+44(0)23 8120 4519; christopher.kipps@uhs.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: October 13, 2022
• Study Start: September 28, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

GB (3)