Detecting an MCI and Amyloid Digital Neuro Signature(DNS) Using Altoida's Multimodal Digital Biomarkers.

Prior treatment

• ● Participants who have participated in a clinical trial longer than six months of any potential disease-modifying anti-amyloid AD treatment and remained active in the study for a duration of 6 or more months (i.e., continued receiving treatment);
  • Participants who, in the opinion of the Site Principal Investigator, have serious or unstable medical conditions that would prohibit their completion of all study procedures and data collection or that would preclude their participation;
  • Participants undergoing anticoagulant treatment or other blood dyscrasias, only if they need to undergo lumbar puncture for the assessment of amyloid pathology;
  • Participants with a history of stroke or seizures within one year of study start;
  • Participants with a history of chemotherapy within the past five years, or any type of malignancy or cancer that might interfere with the completion of the study, except for non-melanoma skin cancer or prostate cancer in situ;
  • Participants with restrictions of performing physical activities or who are not ambulatory;
  • Participants who have previously been enrolled in a study using the Altoida assessment

• 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 to clinical diagnosis.