Cortical Disarray Measurement in MCI and AD (CONGA)
Research type
Research Study
Full title
An observational longitudinal cohort study to investigate Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer’s disease (CONGA)
IRAS ID
298524
Contact name
Christopher Kipps
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Before a patient is diagnosed with Alzheimer’s Disease (AD) dementia, they may be diagnosed with Mild Cognitive Impairment (MCI). This is when they start to experience problems with memory, language, thinking and judgment, worse than would be expected with normal ageing. But the problem is that MCI does not always lead to dementia, and not knowing can cause uncertainty and worry.
A new technique called Cortical Disarray Measurement (CDM), which uses normal MRI brain scans, may be able to reveal microscopic changes taking place in the brain’s “grey matter”. These changes are normally only seen in the brain through a microscope after a patient has passed away and may be able to be used to identify people with MCI who are likely to progress to Alzheimer’s disease.
The project aims to demonstrate the use of CDM for identification of individuals who progress to dementia. The project also aims to understand how the technology can best help doctors and patients, and to complete a health economics analysis to see whether it could provide savings for patient care in diagnosis and prognosis.
We will complete a longitudinal cohort study, where 200 participants with MCI and mild AD and their companions will be recruited. Participants will be recruited through secondary and tertiary centres where diagnostic investigation or patient monitoring is underway. Participants will be followed for two years at 6 monthly intervals to determine change on standard cognitive and functional measures with MRI examination at baseline and 24 months. The study is observational and will not change normal clinical care.
Optional substudies will be completed for 1) collection of biosamples for Alzheimer’s disease biomarkers and future research and 2) qualitative analysis of patient views and experiences regarding their diagnostic pathway and the potential value of CDM.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
22/NW/0014
Date of REC Opinion
11 Apr 2022
REC opinion
Further Information Favourable Opinion