Trial Outcomes & Findings for Evaluation of a Computerized Complex Instrumental Activities of Daily Living Marker (NMI) (NCT NCT02843529)

Results Overview

The machine learning models capturing voice data, hands micromovements \& micro-errors, posture changes, eye tracking, visuospatial navigation micro-errors and spatio-temporal gait parameters developed for the Altoida system will be tested in this prospective cohort. Sensitivity, specificity and accuracy of the model will be tested in differential diagnosis between the study groups as well as the accuracy of prediction cognitive decline as measured by neuropsychological test battery in the MCI group.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

548 participants

Primary outcome timeframe

approximately 40 months follow up

Results posted on

2024-08-23

Participant Flow

Participant milestones

Participant milestones
Measure	MCI (Including Prodromal AD) Altoida: neuropsychological, MRI, EEG and CSF biomarkers MCI participants will undergo at baseline and every 6 months a neurological examination and a neuropsychological assessment. Alzheimer disease biomarkers' measurements will be performed at inclusion and at the end of the study (or the conversion). Altoida: neuropsychological, MRI, EEG and CSF biomarkers: Data collection at baseline: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects. In both Prodromal and Preclinical AD subjects, APOE genotyping. The local clinical Unit should document the positivity at the baseline session of at least one of the biomarkers of AD mentioned above. Data collection at 6, 12, 24 and 36 months of follow up: clinical (neurological, activity daily life, instrumental activity of the daily life, depression scale)	Cognitively Normal (Including Preclinical AD) Altoida: neuropsychological, MRI, EEG and CSF biomarkers Cognitively normal participants at risk will undergo at baseline and every 6 months a neurological examination and a neuropsychological assessment. Alzheimer disease biomarkers' measurements will be performed at inclusion and at the end of the study (or the conversion). Altoida: neuropsychological, MRI, EEG and CSF biomarkers: Data collection at baseline: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects. In both Prodromal and Preclinical AD subjects, APOE genotyping. The local clinical Unit should document the positivity at the baseline session of at least one of the biomarkers of AD mentioned above. Data collection at 6, 12, 24 and 36 months of follow up: clinical (neurological, activity of the daily life, instrumental activity of the daily
Overall Study STARTED	244	304
Overall Study COMPLETED	213	283
Overall Study NOT COMPLETED	31	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MCI (Including Prodromal AD) n=213 Participants Altoida: neuropsychological, MRI, EEG and CSF biomarkers MCI participants will undergo at baseline and every 6 months a neurological examination and a neuropsychological assessment. Alzheimer disease biomarkers' measurements will be performed at inclusion and at the end of the study (or the conversion). Altoida: neuropsychological, MRI, EEG and CSF biomarkers: Data collection at baseline: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects. In both Prodromal and Preclinical AD subjects, APOE genotyping. The local clinical Unit should document the positivity at the baseline session of at least one of the biomarkers of AD mentioned above. Data collection at 6, 12, 24 and 36 months of follow up: clinical (neurological, activity odaily life, instrumental activity of the daily life, depression scale)	Cognitively Normal (Including Preclinical AD) n=283 Participants Altoida: neuropsychological, MRI, EEG and CSF biomarkers Cognitively normal participants at risk will undergo at baseline and every 6 months a neurological examination and a neuropsychological assessment. Alzheimer disease biomarkers' measurements will be performed at inclusion and at the end of the study (or the conversion). Altoida: neuropsychological, MRI, EEG and CSF biomarkers: Data collection at baseline: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects. In both Prodromal and Preclinical AD subjects, APOE genotyping. The local clinical Unit should document the positivity at the baseline session of at least one of the biomarkers of AD mentioned above. Data collection at 6, 12, 24 and 36 months of follow up: clinical (neurological, activity daily life, instrumental activity of the daily	Total n=496 Participants Total of all reporting groups
Age, Continuous	72 Years STANDARD_DEVIATION 7 • n=213 Participants	65 Years STANDARD_DEVIATION 9 • n=283 Participants	67 Years STANDARD_DEVIATION 8 • n=496 Participants
Sex: Female, Male Female	132 Participants n=213 Participants	175 Participants n=283 Participants	307 Participants n=496 Participants
Sex: Female, Male Male	81 Participants n=213 Participants	108 Participants n=283 Participants	189 Participants n=496 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: approximately 40 months follow up

The machine learning models capturing voice data, hands micromovements \& micro-errors, posture changes, eye tracking, visuospatial navigation micro-errors and spatio-temporal gait parameters developed for the Altoida system will be tested in this prospective cohort. Sensitivity, specificity and accuracy of the model will be tested in differential diagnosis between the study groups as well as the accuracy of prediction cognitive decline as measured by neuropsychological test battery in the MCI group.

Outcome measures

Outcome measures
Measure	MCI (Including Prodromal AD) n=213 Participants Altoida: neuropsychological, MRI, EEG and CSF biomarkers MCI participants will undergo at baseline and every 6 months a neurological examination and a neuropsychological assessment. Alzheimer disease biomarkers' measurements will be performed at inclusion and at the end of the study (or the conversion). Altoida: neuropsychological, MRI, EEG and CSF biomarkers: Data collection at baseline: clinical (neurological, activity daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects. In both Prodromal and Preclinical AD subjects, APOE genotyping. The local clinical Unit should document the positivity at the baseline session of at least one of the biomarkers of AD mentioned above. Data collection at 6, 12, 24 and 36 months of follow up: clinical (neurological, activity daily life, instrumental activity of the daily life, depression scale), stand	Cognitively Normal (Including Preclinical AD) n=283 Participants Altoida: neuropsychological, MRI, EEG and CSF biomarkers Cognitively normal participants at risk will undergo at baseline and every 6 months a neurological examination and a neuropsychological assessment. Alzheimer disease biomarkers' measurements will be performed at inclusion and at the end of the study (or the conversion). Altoida: neuropsychological, MRI, EEG and CSF biomarkers: Data collection at baseline: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects. In both Prodromal and Preclinical AD subjects, APOE genotyping. The local clinical Unit should document the positivity at the baseline session of at least one of the biomarkers of AD mentioned above. Data collection at 6, 12, 24 and 36 months of follow up: clinical (neurological, activity of the daily life, instrumental activity of the daily
Change in Diagnostic Area Under the Receiver Operating Characteristic Curve (ROC-AUC)	0.94 probability Interval 0.93 to 0.96	0.91 probability Interval 0.9 to 0.95

SECONDARY outcome

Timeframe: baseline, 6, 12, 24, 36 and 42 months of follow up

Clinical Dementia Rating (CDR), including CDR sum of boxes (CDR-SB) and clinician's diagnostic assessment