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Evaluation of a Computerized Complex Instrumental Activities of Daily Living Marker (NMI) (AltoidaML)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02843529
Recruitment Status : Completed
First Posted : July 26, 2016
Results First Posted : December 16, 2020
Last Update Posted : January 26, 2021
Sponsor:
Collaborators:
Greek Alzheimer's Association and Related Disorders
University of Roma La Sapienza
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Neuromed IRCCS
Scripps Health
Global Brain Health Institute (GBHI)
Takeda Pharmaceuticals International, Inc.
Research Center on Computational Biomarkers (RCCBM)
BiHELab - Bioinformatics and Human Electrophysiology Lab
Fundacion Clinic per a la Recerca Biomédica
University of Dublin, Trinity College
University of Barcelona
EIT Health
Klinik Hirslanden, Zurich
Center for BrainHealth - The University of Texas at Dallas
Information provided by (Responsible Party):
Altoida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Diagnostic
Conditions Alzheimer Disease
Mild Cognitive Impairment
Memory Disorders
Cognitive Impairment
Dementia
Presymptomatic Disease
Intervention Other: Altoida: neuropsychological, MRI, EEG and CSF biomarkers
Enrollment 548
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prodromal AD (MCI) Preclinical AD (Cognitively Normal)
Hide Arm/Group Description

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)

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

Period Title: Overall Study
Started 244 304
Completed 213 283
Not Completed 31 21
Arm/Group Title Prodromal AD (MCI) Preclinical AD (Cognitively Normal) Total
Hide Arm/Group Description

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)

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 of all reporting groups
Overall Number of Baseline Participants 213 283 496
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 213 participants 283 participants 496 participants
72  (7) 65  (9) 67  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 213 participants 283 participants 496 participants
Female 132 175 307
Male 81 108 189
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Change in Diagnostic Area Under the Receiver Operating Characteristic Curve (ROC-AUC)
Hide Description 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.
Time Frame 42 months of follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prodromal AD (MCI) Preclinical AD (Cognitively Normal)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 213 283
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: probability
0.94
(0.93 to 0.96)
0.91
(0.90 to 0.95)
2.Secondary Outcome
Title Change From Baseline in Clinical Measure 1
Hide Description Clinical Dementia Rating (CDR), including CDR sum of boxes (CDR-SB) and clinician's diagnostic assessment
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Change From Baseline in Clinical Measure 2
Hide Description Geriatric Depression Scale (GDS)
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Change From Baseline in Clinical Measure 3
Hide Description Functional Assessment Questionnaire (FAQ)
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change From Baseline in Clinical Measure 4
Hide Description Mini Mental Status Exam (MMSE)
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change From Baseline in Clinical Measure 5
Hide Description Neuropsychiatric Inventory Questionnaire (NPI-Q)
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Change From Baseline in Clinical Measure 6
Hide Description Activities of the daily life (ADL)
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Change From Baseline in Clinical Measure 7
Hide Description Instrumental activities of the daily life (iADL)
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Change From Baseline in Cognitive Measure
Hide Description ADAS Cog
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Change From Baseline in Cognitive Measure
Hide Description -Rey-Osterrieth Complex Figure Test (Copy)
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Change From Baseline in Cognitive Measure
Hide Description Trail Making Test
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Change From Baseline in Cognitive Measure
Hide Description Digit Span Forward
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Change From Baseline in Cognitive Measure
Hide Description Category Fluency (Animals & Vegetables)
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Change From Baseline in Cognitive Measure
Hide Description Digit Span Backward
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Change From Baseline in Cognitive Measure
Hide Description Rey Osterrieth Complex Figure Test (30 minute delay)
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Change From Baseline in Cognitive Measure
Hide Description Wechsler Memory Scale - Revised (WMS-R) Digit Span
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Change From Baseline in Cognitive Measure
Hide Description Wechsler Memory Scale Logical Memory
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Change From Baseline in Cognitive Measure
Hide Description Wechsler Memory Scale Paragraph Memory (Immediate & Delayed Recall)
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Change From Baseline in Cognitive Measure
Hide Description Wechsler Adult Intelligence Scale - Revised (WAIS-R) Digit-Symbol Substitution Test
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Change From Baseline in Cognitive Measure
Hide Description Rey Auditory Verbal Learning Test (RAVLT)
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
21.Secondary Outcome
Title Secondary Resting State EEG Endpoints
Hide Description EEG endpoints (occipital, parietal, and temporal sources of delta and low-frequency alpha rhythms) according to the PharmaCog WP5 European ADNI. These markers are expected to be related to disease status at baseline assessment and disease progression at follow-ups. Exploratory probability level of p < 0.05.
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
22.Secondary Outcome
Title Secondary Resting State Auditory Oddball ERP Endpoints
Hide Description ERP endpoints (latency of scalp parietal P3b peak and activity of the cingulate and temporal-parietal sources of P3b peak according to PharmaCog WP5 European ADNI). These markers are expected to be related to disease status at baseline assessment and disease progression at follow-ups. Exploratory probability level of p < 0.05.
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
23.Secondary Outcome
Title Total Abeta 1-42 (Aβ42) Amyloid Deposition
Hide Description Currently available evidence strongly supports the position that the initiating event in Alzheimer's disease (AD) is related to abnormal processing of beta-amyloid (Abeta) peptide, ultimately leading to formation of Abeta plaques in the brain. Baseline amount of CSF Abeta(42) will be investigated.
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
24.Secondary Outcome
Title Change of Brain Amyloid Deposition
Hide Description Biomarkers of brain beta-amyloidosis are reductions in CSF Abeta(42) and increased amyloid PET tracer retention. The change in amyloid deposition as measured by Abeta 1-42 (Aβ42) and its relation to the genetic, clinical, neuropsychological, EEG and ERP endpoints measurement will be assessed.
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
25.Secondary Outcome
Title Change of CSF Biomarkers Tau and ptau181 Values
Hide Description The change in CSF biomarkers tau and ptau181 values and its relation to the genetic, clinical, neuropsychological, EEG and ERP endpoints measurement will be assessed.
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
26.Secondary Outcome
Title MRI (Optional)
Hide Description Relationship between MRI measures (brain volume, hippocampus atrophy, vascular lesions) and biomarkers.
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
27.Secondary Outcome
Title Changes in Driving Breaking Force
Hide Description Changes in driving behavior, such as breaking force observed continuesly through in-car sensors or dongles.
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
28.Secondary Outcome
Title Changes in Driving Acceleration Velocity
Hide Description Changes in driving behavior, such as acceleration velocity observed continuesly through in-car sensors or dongles.
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
29.Secondary Outcome
Title Changes in Driving Direction
Hide Description Changes in driving behavior, such as sudden changes of direction observed continuesly through in-car sensors or dongles.
Time Frame baseline, 6, 12, 24, 36 and 42 months of follow up
Outcome Measure Data Not Reported
30.Secondary Outcome
Title Changes in Driving Violations
Hide Description Changes in driving behavior, such as speed limit violations observed continuesly through in-car sensors or dongles.
Time Frame Continuous measurement for 42 months
Outcome Measure Data Not Reported
Time Frame 40 months
Adverse Event Reporting Description This was an observation study, no intervention included.
 
Arm/Group Title Prodromal AD (MCI) Preclinical AD (Cognitively Normal)
Hide Arm/Group Description

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)

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

All-Cause Mortality
Prodromal AD (MCI) Preclinical AD (Cognitively Normal)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Prodromal AD (MCI) Preclinical AD (Cognitively Normal)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prodromal AD (MCI) Preclinical AD (Cognitively Normal)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ioannis Tarnanas
Organization: Altoida Inc.
Phone: +18325975076
EMail: Ioannis@altoida.com
Other Publications:
Layout table for additonal information
Responsible Party: Altoida
ClinicalTrials.gov Identifier: NCT02843529    
Other Study ID Numbers: altoidaML01
First Submitted: May 18, 2016
First Posted: July 26, 2016
Results First Submitted: September 15, 2020
Results First Posted: December 16, 2020
Last Update Posted: January 26, 2021