An observational study in Alzheimer's Disease and Mild Cognitive Impairment, sponsored by Altoida. Active, not recruiting at 1 site in Greece. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Altoida · Observational
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.
Relevant outcome measurements for the study have been selected through the following longitudinal process:
Identification of functional domains that meet one or more of the following criteria:
Predicts conversion of MCI due to AD to mild AD dementia. Impaired in mild AD dementia. Predicts functional decline in AD dementia. Reported as important by an AD dementia patient advisory board. Identification of candidate RMTs to cover real-life measurement of the functional domains identified in step 1.
Identification of candidate digital biomarkers, which are life-log data such as steps, sleep, heart rate and exercise collected by RMTs, to cover clinical measurement of the functional domains identified in step 1.
Functional domains, RMTs, and clinical assessments that resulted from the selection process above are listed in Table 1, and 2. The selection process described in step 1 resulted in the identification of the following functional domains, sorted by relevance [HR (highly relevant), R (relevant), N (neutral), and LR (least relevant)].
The central assumption of the study is that functional disabilities proportionally increase with the progressive worsening of the AD. A recent classification proposed by the FDA 2018 draft guidance for the development of novel treatments in AD identifies the early disease progression in 3 stages: (a) Patients with characteristic pathophysiologic changes of Preclinical AD but no evidence of clinical impact (Stage 1) (b) Patients with characteristic pathophysiologic changes of AD and subtle or more apparent detectable abnormalities on sensitive neuropsychological measures, but no functional impairment (Stage 2), and (c) Patients with characteristic pathophysiologic changes of AD and subtle or more apparent detectable abnormalities on sensitive neuropsychological measures, but mild and detectable functional impairment (Stage 3). The aim of the DNS study is to assess the feasibility, utility and performance of selected RMTs in profiling ADL in real-world settings. This goal will be achieved by evaluating digital signals collected either continuously, or daily, or weekly at home, either using wearable devices or home-located ambient devices, determining as much as possible the specific context-dependent conditions in which the signals are measured. As a general hypothesis, RMTs will deliver more sensitive and less variable measurements when compared to standard clinical assessments, questionnaires and tests measuring specific functional capabilities in the clinics.
The most important results of the study will be (1) the evidence that some RMT parameters will provide insights for lower variance than the standard scales or questionnaires, (2) the capacity of Altoida, Inc. NMI and/or RMTs to significantly differentiate the preclinical AD stages 1 \& 2 when compared to healthy volunteers with negative AD biomarkers as a control, and (3) a similar capabilities of Altoida, Inc. NMI and/or RMTs to detect monotonic change in the mild cognitive impairment (MCI) due to AD group and, even more, in mild, moderate and severe AD dementia groups, proportional to the specific functional impairment known to worsen during the disease progression.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 3,500 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Altoida is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The main study comprises 3,510 subjects matched by age and gender. In the sub-study of amyloid PET, FDG PET, tau PET and fMRI scans: 400 subjects comprised of (1) >100 of cognitively unimpaired with (A-, T-, (N)-) group, (2) >100 of cognitively unimpaired with (A+, T+, (N)- or A+, T+, (N)+) groups, (3) >100 of mild cognitive impairment with (A+, T+, (N)- or A+, T+, (N)+) groups and (4) >100 of mild cognitive impairment with (A-, T-, (N)-).
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):
For those participating in the sub-study from each intended respective subject grouping described in Sub-study section, signature on an additional Informed Consent
1b. Healthy volunteer subjects (n=400):
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study. Those criteria would be applied at the subject screening:
2a. For subjects in the Alzheimer's continuum and those with non-AD pathologic changes:
Failure to show negative PCR results for Covid19 or proof of vaccination
2b. Healthy volunteer subjects:
Observational Study -The main study (tier 1) comprises 3,510 subjects matched by age and gender at a group level and aged over 50 years with a study partner available to actively contribute to the study will be recruited from memory clinics and/or ongoing observational studies in 3 sites across Greece
Observational Study- Sub-study at the baseline visit (Tier 2) Amyloid Positron Emission Tomography (PET): groups (1), (2), (3), (4) as described below fluorodeoxyglucose (FDG) PET : groups (1), (2), (3), (4) as described below More than 400 subjects comprised of (1) \>100 of cognitively unimpaired with (A-, T-, (N)-) group, (2) \>100 of cognitively unimpaired with (A+, T+, (N)- or A+, T+, (N)+) groups, (3) \>100 of mild cognitive impairment with (A+, T+, (N)- or A+, T+, (N)+) groups and (4) \>100 of mild cognitive impairment with (A-, T-, (N)-) group will take Amyloid PET and FDG PET as sub-study.
ADL using selected RMTs
Assess statistically significant difference between healthy volunteers, preclinical AD, MCI due to AD, mild, moderate and severe AD dementia in outcome measures of ADL using selected RMTs.
Time frame: 5 years
Neuropsychological assessment like the Clinical Dementia Rating (CDR) scale
Assess statistically significant difference between healthy volunteers, preclinical AD, MCI due to AD, mild, moderate and severe AD dementia using RMTs, neuropsychological assessment like CDR.
Time frame: 5 years
Neuropsychological assessment like Altoida, Inc. Neuro Motor Index (NMI) medical device
Assess statistically significant difference between healthy volunteers, preclinical AD, MCI due to AD, mild, moderate and severe AD dementia using RMTs, neuropsychological assessment like the Altoida, Inc. Neuro Motor Index (NMI) medical device.
Time frame: 5 years
Demographics, medical history, physical status, life-habits, and medication from the analysis of neuropsychological assessments.
Assess statistically significant difference between healthy volunteers, preclinical AD, MCI due to AD, mild, moderate and severe AD dementia focusing on their demographics, medical history, physical status, life-habits, and medication from the analysis of neuropsychological assessments.
Time frame: 5 years
Demographics, medical history, physical status, life-habits, and medication from the analysis of biomarker measurements.
Assess statistically significant difference between healthy volunteers, preclinical AD, MCI due to AD, mild, moderate and severe AD dementia focusing on their demographics, medical history, physical status, life-habits, and medication from the analysis of biomarker measurements.
Time frame: 5 years
Demographics, medical history, physical status, life-habits, and medication from the analysis of RMTs
Assess statistically significant difference between healthy volunteers, preclinical AD, MCI due to AD, mild, moderate and severe AD dementia focusing on their demographics, medical history, physical status, life-habits, and medication from the analysis of RMTs.
Time frame: 5 years
Demographics, medical history, physical status, life-habits, and medication from the analysis of Altoida NMI medical device.
Assess statistically significant difference between healthy volunteers, preclinical AD, MCI due to AD, mild, moderate and severe AD dementia focusing on their demographics, medical history, physical status, life-habits, and medication from the analysis of Altoida NMI medical device.
Time frame: 5 years
Plan to share: No
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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