Digitally-enhanced, Decentralized, Multi-omics Observational Cohort

• Conditions: Presymptomatic Disease; Mild Cognitive Impairment; Memory Loss (Excluding Dementia); Alzheimer Disease; Parkinson's Disease and Parkinsonism; Cognitive Change; Dementia
• Interventions: Diagnostic Test: AltoidaML

• Registration Number: NCT04701177
• Lead Sponsor: Greece 2021 Committee

Brief Summary

The study is carried out as part of the GR2021 Priority project "Healthy Brains for life (Age 20-99): Digitally-enhanced personalized medicine study ANANEOS" and code numbered GR-00546 and it will look at the decentralized and remote assessment of the symptoms of preclinical stages in Alzheimer's disease and movement disorders, e.g. Parkinson's. For this study we are looking for participants aged over 45 without cognitive complaints or with subjective perception of cognitive decline or with mild cognitive complaints. Specific aims for the proposed study: a) to develop novel sensitive measures that can provide an early identification of those SCD and MCI individuals harboring AD pathology that are at high risk of cognitive worsening over time; b) to track pre-motor stages in Parkinson's disease and trials that enable active digital functional biomarkers; c) to track disease progression during pre-dementia and pre-motor stages in clinical practice and trials with measures that enable to capture subtle changes.

Detailed Description

Digital technologies, particularly those based on the use of smartphones, wearables 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 the potential to obtain better measurements of behavioural 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 specific incipient functional impairments even at the very early stages of AD.

Therefore, the main hypothesis of this project is that RMTs should allow the detection of impairments in functional components of ADLs that occur below the threshold of clinical scale detection or disability questionnaires.

ANANEOS is an independent Brain Registry (patient registry), created as an organized system to collect uniform data (clinical and other) to evaluate specified outcomes for the Neurological Progression Index (NPI) and serves as a real-world view of clinical practice, patient outcomes, safety, and can serve a number of evidence development and decision making purposes.

Study Timeline

• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-08
• Study Start: 2021-03-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2031-10-30
• Study Completion: 2031-11-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mild cognitive impairment (MCI)	AltoidaML	Single or multidomain cognitive deficits with preservation of activities of daily living.
Prodromal Parkinson's Disease	AltoidaML	Parkinson's disease (PD) has a prodromal phase during which nonmotor clinical features as well as physiological abnormalities may be present.
Subjective cognitive decline (SCD)	AltoidaML	subjective perception of cognitive decline in the absence of cognitive impairment in formal neuropsychological assessment.

Primary Outcome Measures

Name	Time	Method
Establish standardized protocols for acquisition, transfer & analysis of clinical, digital, imaging, biologic and genetic data that can be used in the AD & PD research community.	baseline to 60 months	This protocol will build on the existing Greek Brain Registry infrastructure
Comprehensive and uniformly acquired dataset	baseline to 60 months	Develop a comprehensive and uniformly acquired clinical, digital and imaging dataset and repository of biological and genetic samples that would be available to the PD research community to test hypotheses of the underlying molecular pathobiology of PD, enable modeling of PD progression to identify clinical and/or data driven PD progression sub-sets, and inform studies testing PD therapeutics (for examples, clinical trials targeting synuclein, LRRK2, GBA as well as other targets)
Change in Diagnostic Area Under the Receiver Operating Characteristic Curve (ROC-AUC)	60 months of 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 predicting cognitive trajectories as measured by neuropsychological test battery in both groups.

Secondary Outcome Measures

Name	Time	Method
Establish the probability of phenoconversion to PD	study intervals ranging from baseline to 60 months	Evaluate the probability of phenoconversion to PD for individuals with prodromal PD enrolled in the prodromal cohorts (including individuals with RBD, olfactory loss, a LRRK2, GBA, SNCA or rare genetic mutations (such as Parkin or Pink1) and/ or other risk factors for PD with and without DAT deficit).

Trial Locations

Locations (4)

Ionian University; 🇬🇷 Corfu, Greece

Panhellenic Federation Of Alzheimer's Disease And Related Disorders; 🇬🇷 Thessaloniki, Greece

Greek Alzheimer's Association and Related Disorders; 🇬🇷 Thessaloníki, Greece

BRNX clinic, affiliated with Dubai Health Authority; 🇦🇪 Dubai, United Arab Emirates