Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease (NCT05579236) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
United Kingdom400 participantsStarted 2022-09-28
Plain-language 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.
Who can participate
Age range50 Years – 90 Years
SexALL
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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
What they're measuring
1
CDR Progression
Timeframe: Baseline (Study day 1) to month 24
Trial details
NCT IDNCT05579236
SponsorUniversity Hospital Southampton NHS Foundation Trust