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 range
50 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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