Detecting an MCI and Amyloid Digital Neuro Signature(DNS) Using Altoida's Multimodal Digital Biom… (NCT06223438) | Clinical Trial Compass
CompletedNot Applicable
Detecting an MCI and Amyloid Digital Neuro Signature(DNS) Using Altoida's Multimodal Digital Biomarkers.
United States614 participantsStarted 2024-01-12
Plain-language summary
The purpose of this study is to establish multiple points of clinical validity for the Altoida digital biomarker assessment in individuals with a clinical diagnosis of cognitively normal (CN) and Mild Cognitive Impairment (MCI). Participants will use the Altoida app and the de-identified sensor data captured by the device will be used to train specific machine-learning algorithms to recognize early symptoms of cognitive decline, such as MCI or MCI with likelihood of amyloid pathology, as measured by digital biomarkers (T1 - Visit 1). Participants will be invited for an additional visit to evaluate test-retest reliability (T1' - Visit 2). Optionally, an updated variation of the Altoida app will be tested over the course of two additional visits to ensure optimal digital assessment delivery based on best practices in neuropsychological testing, user experience design, and data collection integrity (T2 - Visit 3 and T2' - Visit 4).
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:
* Participants must provide written informed consent in the EC/IRB-approved informed consent form or have a Legally Authorized Representative (LAR) provide written consent on the participant's behalf;
* Male or female, 50+ years at the time of consent;
* Participants must be willing to comply with all study procedures as outlined in the informed consent;
* Fluency in the language of the tests used at the study site;
* At least four years of formal education (from primary school onwards);
* Adequate vision to complete the Altoida assessment and neuropsychological tests with or without corrective lenses;
* Have undisturbed locomotion;
* Participants should have, when available, an amyloid status assessment result (positive or negative) through CSF analysis or amyloid-PET testing. Historical positive amyloid data is accepted up to 18 months before taking the Altoida assessment. Historical amyloid negative data can be accepted up to 6-12 months before the Altoida assessment if MMSE\>26. If historical amyloid data is unavailable, determining amyloid status will be an optional component of the study protocol. The decision to include this assessment and the specific method employed will be collaboratively discussed and decided upon between the study sponsor and the respective study site;
* Optionally, participants might present, when available, a historical APOE, APP/PSEN1/2 genotype determination, and/or historical MRI/CT scan results relevant …
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.