NCT04701177

Digitally-enhanced, Decentralized, Multi-omics Observational Cohort

Precision Medicine Initiative Against Alzheimer's Disease (PMIAAD): Digitally-enhanced, Decentralized, Multi-omics, Observational Cohort

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 100,000 (estimated)
• Sponsor: Greece 2021 Committee · Other Government
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

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 Neuropsychiatric 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.

Conditions

• Presymptomatic Disease
• Mild Cognitive Impairment
• Memory Loss (Excluding Dementia)
• Cognitive Change
• Dementia
• Alzheimer Disease
• Parkinson's Disease and Parkinsonism

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Teleph0s digital phenotyping platform	Computerized multimodal assessment of complex neurological and psychiatric interviews (AI-COPE).

Timeline

• Start date: 2021-03-15
• Primary completion: 2031-10-30
• Completion: 2031-11-30
• First posted: 2021-01-08
• Last updated: 2026-03-18

Locations

4 sites across 2 countries: Greece, Spain

Regulatory

• FDA-regulated device study