Diagnosis and Monitoring of Disease Progression Using Deep Neuro Signatures (NCT05153941) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Diagnosis and Monitoring of Disease Progression Using Deep Neuro Signatures
Greece3,500 participantsStarted 2022-01-31
Plain-language summary
Alzheimer's disease (AD) clinically characterized by the cognitive impairment and lowering of various functional abilities lead to staggering costs and suffering, which are particularly related to the social impacts of caring for increasingly disabled individuals. Some of these changes can be almost undetectable in the early stages of the disease, worsening over time often and at a varying rate of progression in different people. The traditional clinical scales or questionnaires such as ADCS (Alzheimer's Disease Cooperative Study) - ADL (Activities of Daily Living) for detecting such functional disabilities are typically blunt and rely on direct observation or caregiver recall. Digital technologies, particularly those based on the use of smart phones, wearable and/or home-based monitoring devices, here defined as 'Remote Measurement Technologies' (RMTs), provide an opportunity to change radically the way in which functional assessment is undertaken in AD, RMTs have potential to obtain better measurements of behavioral and biological parameters associated with individual Activities of Daily Living (ADL) when compared to the current subjective scales or questionnaires. Divergence from normative ADL profiles could objectively indicate the presence of incipient functional impairment at the very early stages of AD. Therefore, the main hypothesis of this study is that RMTs should allow the detection of impairments in functional components of ADLs that occur below the detection threshold of clinical scale or questionnaires.
Who can participate
Age range
50 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.
• Inclusion criteria
Subjects enrolled in this study are diagnosed based on the established criteria as described below by physicians/medical doctors with expertise in Alzheimer's disease and other neurodegenerative disorders. To be eligible to participate in this study, a subject must meet the following criteria:
1a. For subjects in the Alzheimer's continuum and those with non-AD pathologic changes, (n=3,110):
* Male or female over 50 years of age.
* Approximately age and gender matched among groups as classified below.
* A study partner (caregiver/family member) is available to collaborate to visit the site together with the subject and give necessary information on the subject.
* Physician's clinical judgement of individuals by classifying into three syndromal stages of cognitive continuum: cognitively unimpaired, mild cognitive impairment, and dementia as described in 2018 NIA-AA research framework \[39\], \[40\] while taking into account of clinical assessment performance such as MMSE and CDR scores. This syndromic staging is applicable to all members of a research cohort independent from biomarker profiles.
* Numeric clinical staging in 2018 NIA-AA research framework may also be applied to cognitive staging in the Alzheimer's continuum \[40\] .
* cognitively unimpaired
* mild cognitive impairment
* mild dementia
* moderate dementia
* severe dementia
* AT(N) biomarker profile as evidenced by CSF test results is combined with the clinical staging for the classification…
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.
1This study is using digital tools like the Altoida Neuro Motor Index app and remote monitoring tasks to track things like memory and movement — can you explain what those assessments actually involve day-to-day, and whether the time commitment is realistic given my current situation?
2Since this trial is listed as 'active, not recruiting,' does that mean there's no longer a way to participate, and if so, are there similar observational studies using digital monitoring tools that I might still be able to join?
3This appears to be an observational study focused on diagnosis and tracking disease progression rather than testing a new treatment — does that mean there's no potential direct therapeutic benefit for me, and how would participation fit alongside whatever treatment plan you'd recommend for me?
4The study is collecting a lot of personal data including medical history, life habits, medications, and biomarker measurements — what do I need to understand about how that information is stored, shared, and protected before agreeing to something like this?
5Since one of the main tools being evaluated is the Clinical Dementia Rating scale alongside this newer Altoida device, could the findings from a study like this eventually change how my own progression is monitored, and is there value in asking for these kinds of digital assessments as part of my regular care now?
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
ADL using selected RMTs
Timeframe: 5 years
2
Neuropsychological assessment like the Clinical Dementia Rating (CDR) scale
Timeframe: 5 years
3
Neuropsychological assessment like Altoida, Inc. Neuro Motor Index (NMI) medical device
Timeframe: 5 years
4
Demographics, medical history, physical status, life-habits, and medication from the analysis of neuropsychological assessments.
Timeframe: 5 years
5
Demographics, medical history, physical status, life-habits, and medication from the analysis of biomarker measurements.
Timeframe: 5 years
6
Demographics, medical history, physical status, life-habits, and medication from the analysis of RMTs
Timeframe: 5 years
7
Demographics, medical history, physical status, life-habits, and medication from the analysis of Altoida NMI medical device.