Presymptomatic DiseaseANANEOSNCT04701177
Digitally-enhanced, Decentralized, Multi-omics Observational Cohort
An observational study of Presymptomatic Disease and Mild Cognitive Impairment, run by Greece 2021 Committee at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Presymptomatic Disease, Mild Cognitive Impairment, Memory Loss (Excluding Dementia)
- What is being tested?
- Teleph0s digital phenotyping platform
- How many people
- 100,000 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 15 Mar 2021to 30 Nov 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study is a decentralized, observational, digital assessment cohort study in healthy volunteers with negative AD biomarkers as control, subjects with MBI, preclinical AD and MCI due to AD dementia.
Who may be able to join
- Male or female over 45 years of age.
- Subject is seen at a memory clinic or is part of an observational study.
- An informant (caregiver/family member) is available to collaborate.
- Diagnosis of individuals in the AD biological continuum with evidence of amyloid-beta accumulation based on the presence of Aβ load AD biomarkers (either in CSF or PET scan), MMSE, CDR score and cognitive tests as defined by the Guidance document of EMA (2016) or FDA (2018):
- preclinical AD: MMSE≥27 and CDR=0, either none or borderline cognitive deficits (compatible with FDA stages 1 and 2, with positive AD biomarkers). Patients reporting subjective cognitive decline who meet the criteria above are eligible for assignment to the preclinical AD group.
- prodromal AD/MCI due to AD: MMSE >23, CDR=0.5, impairment on cognitive testing with RBANS (compatible with stage 3 FDA, with positive AD biomarkers).
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- Prodromal PD: Male or female age 60 years or older (except age 30 years or older for SNCA, or rate genetic mutations (such as Parkin or Pink1) participants).
- Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before DaTscan imaging.
- Informed consent signed by the subject and informant.
- Informant should be able to read and communicate in the language of the recruitment centre and available to actively engage in tests and questionnaires.
- Subject and the informant own a smartphone.
- Male or female over 45 years of age.
- Individuals with no evidence of amyloid-beta accumulation based on the presence of Aβ load AD biomarkers (either in CSF or PET scan).
- Approximately age and gender matched to AD subjects on a group level.
- An informant is available to collaborate.
- MMSE >27, CDR=0.
- In otherwise good health conditions, or with diagnosis mild chronic disorders (of metabolic, respiratory, immunological, cardiologic, and metabolic origin) or any other affections that are controlled by the therapy and do not importantly limit ADLs or social interactions.
- Able to read and to communicate in the language of the recruitment centre.
- nformed consent signed by the subject and caregiver.
- Subject and informant own a smartphone.
Who cannot join
- Presence of an additional neurological or psychiatric disease that may affect ADL, cognitive function or social interactions.
- Clinical diagnosis of PD, other parkinsonism, or dementia.
- Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.
- Current treatment with anticoagulants (e.g. coumadin, heparin) that might preclude safe completion of the lumbar puncture.
- Abnormal VB12 value.
- Any other kind of disorders that relevantly affect mobility and/or ADL, cognitive function or social interactions (e.g., immune-mediated inflammatory disorders, recovery from recent trauma, stroke, etc.).
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- TSH above normal range
- T3 or T4 outside normal range with clinically significant.
- Presence of an additional neurological or psychiatric disease that may affect ADL, cognitive function or social interactions.
- Diagnosis of any disorders or post traumatic conditions that are not fully controlled by the therapy and produce relevant limitations of ADL, cognitive function or social interactions.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Greece3 sites
Ionian University
Corfu, Corfu, 49100
Panhellenic Federation Of Alzheimer's Disease And Related Disorders
Thessaloniki, 54643
Greek Alzheimer's Association and Related Disorders
Thessaloniki, 55250
About this study
Official title: Precision Medicine Initiative Against Alzheimer's Disease (PMIAAD): Digitally-enhanced, Decentralized, Multi-omics, Observational Cohort
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.
Read the 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
- Being tested
- Teleph0s digital phenotyping platform
- Keywords
- Digital Biomarkers
- Medical subject headings
- Asymptomatic Diseases, Cognitive Dysfunction, Memory Disorders, Dementia, Alzheimer Disease, Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teleph0s digital phenotyping platformDiagnostic test
Computerized multimodal assessment of complex neurological and psychiatric interviews (AI-COPE).
| Study group | Role | What they receive |
|---|---|---|
| Mild Behavioural Impairment (MBI) | Mild Behavioral Impairment (MBI) is a neurobehavioral syndrome characterized by new, persistent psychiatric symptoms in older adults (aged 50+) who do not have dementia. Often together with subjective perception of cognitive decline in the absence of cognitive impairment in formal neuropsychological assessment. Receives: Diagnostic Test: Teleph0s digital phenotyping platform | |
| Mild cognitive impairment (MCI) | Single or multidomain cognitive deficits with preservation of activities of daily living. Receives: Diagnostic Test: Teleph0s digital phenotyping platform | |
| Prodromal Parkinson's Disease | Parkinson's disease (PD) has a prodromal phase during which nonmotor clinical features as well as physiological abnormalities may be present. Receives: Diagnostic Test: Teleph0s digital phenotyping platform | |
| Symptomatic Parkinson's | To be classified in a symptomatic cohort, individuals typically meet the Movement Disorder Society (MDS) clinical diagnostic criteria, which require the presence of parkinsonism as the foundational baseline. Receives: Diagnostic Test: Teleph0s digital phenotyping platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
This protocol will build on the existing Greek Brain Registry infrastructure
Measured: baseline to 60 months
Comprehensive and uniformly acquired dataset
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)
Measured: baseline to 60 months
Change in Diagnostic Area Under the Receiver Operating Characteristic Curve (ROC-AUC)
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.
Measured: 60 months of follow up
Secondary outcomes (1)
Establish the probability of phenoconversion to PD
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).
Measured: study intervals ranging from baseline to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start15 Mar 2021
- Primary completion30 Oct 2031 (estimated)
- Study completion30 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Presymptomatic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Greece 2021 Committee
- Sponsor type
- Other government
- Collaborators
- Ionian University, Greek Alzheimer's Association and Related Disorders, Panhellenic Federation of Alzheimer's Disease and Related Disorders, Hospital Clinic of Barcelona, Teleph0s LLC
- Responsible party
- Principal investigator, Ioannis Tarnanas, Greece 2021 Committee
- Investigators
- Panagiotis Vlamos, PhD, Study chair, Bioinformatics and Human Electrophysiology Laboratory, Department of Informatics, Ionian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701177
- Sponsor's protocol ID
- ANANEOS-GP2
- Other IDs
- GR-00546
- Acronym
- ANANEOS
- Status last verified
- Sep 2026
- First submitted
- 6 Jan 2021
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Buegler M, Harms R, Balasa M, Meier IB, Exarchos T, Rai L, Boyle R, Tort A, Kozori M, Lazarou E, Rampini M, Cavaliere C, Vlamos P, Tsolaki M, Babiloni C, Soricelli A, Frisoni G, Sanchez-Valle R, Whelan R, Merlo-Pich E, Tarnanas I. Digital biomarker-based individualized prognosis for people at risk of dementia. Alzheimers Dement (Amst). 2020 Aug 19;12(1):e12073. doi: 10.1002/dad2.12073. eCollection 2020.
PubMed 32832589Meier IB, Buegler M, Harms R, Seixas A, Coltekin A, Tarnanas I. Using a Digital Neuro Signature to measure longitudinal individual-level change in Alzheimer's disease: the Altoida large cohort study. NPJ Digit Med. 2021 Jun 24;4(1):101. doi: 10.1038/s41746-021-00470-z.
PubMed 34168269
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine Initiative Against Alzheimer's Disease (PMIAAD): Digitally-enhanced, Decentralized, Multi-omics, Observational Cohort
- ClinicalTrials.gov ID
- NCT04701177
- Acronym / sponsor ID
- ANANEOS / ANANEOS-GP2
- Conditions
- Presymptomatic Disease, Mild Cognitive Impairment, Memory Loss (Excluding Dementia), Cognitive Change, Dementia, Alzheimer Disease
- Keywords
- Digital Biomarkers
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Greece 2021 CommitteeOther government
- Collaborators
- Ionian University, Greek Alzheimer's Association and Related Disorders, Panhellenic Federation of Alzheimer's Disease and Related Disorders, Hospital Clinic of Barcelona, Teleph0s LLC
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 30 Oct 2031 (estimated)
- Study completion
- 30 Nov 2031 (estimated)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild Behavioural Impairment (MBI) | – | Diagnostic Test: Teleph0s digital phenotyping platformMild Behavioral Impairment (MBI) is a neurobehavioral syndrome characterized by new, persistent psychiatric symptoms in older adults (aged 50+) who do not have dementia. Often together with subjective perception of cognitive decline in the absence of cognitive impairment in formal neuropsychological assessment. |
| Mild cognitive impairment (MCI) | – | Diagnostic Test: Teleph0s digital phenotyping platformSingle or multidomain cognitive deficits with preservation of activities of daily living. |
| Prodromal Parkinson's Disease | – | Diagnostic Test: Teleph0s digital phenotyping platformParkinson's disease (PD) has a prodromal phase during which nonmotor clinical features as well as physiological abnormalities may be present. |
| Symptomatic Parkinson's | – | Diagnostic Test: Teleph0s digital phenotyping platformTo be classified in a symptomatic cohort, individuals typically meet the Movement Disorder Society (MDS) clinical diagnostic criteria, which require the presence of parkinsonism as the foundational baseline. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study is a decentralized, observational, digital assessment cohort study in healthy volunteers with negative AD biomarkers as control, subjects with MBI, preclinical AD and MCI due to AD dementia.
Key inclusion criteria (20 listed)
- Male or female over 45 years of age.
- Subject is seen at a memory clinic or is part of an observational study.
- An informant (caregiver/family member) is available to collaborate.
- Diagnosis of individuals in the AD biological continuum with evidence of amyloid-beta accumulation based on the presence of Aβ load AD biomarkers (either in CSF or PET scan), MMSE, CDR score and cognitive tests as defined by the Guidance document of EMA (2016) or FDA (2018):
- preclinical AD: MMSE≥27 and CDR=0, either none or borderline cognitive deficits (compatible with FDA stages 1 and 2, with positive AD biomarkers). Patients reporting subjective cognitive decline who meet the criteria above are eligible for assignment to the preclinical AD group.
Key exclusion criteria (10 listed)
- Presence of an additional neurological or psychiatric disease that may affect ADL, cognitive function or social interactions.
- Clinical diagnosis of PD, other parkinsonism, or dementia.
- Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.
- Current treatment with anticoagulants (e.g. coumadin, heparin) that might preclude safe completion of the lumbar puncture.
- Abnormal VB12 value.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teleph0s digital phenotyping platformComputerized multimodal assessment of complex neurological and psychiatric interviews (AI-COPE). | Diagnostic test | Mild Behavioural Impairment (MBI), Mild cognitive impairment (MCI), Prodromal Parkinson's Disease, Symptomatic Parkinson's |
Primary outcome
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.
Time frame: baseline to 60 months
This protocol will build on the existing Greek Brain Registry infrastructure
Comprehensive and uniformly acquired dataset
Time frame: 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)
Time frame: 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.
1 secondary outcome
Establish the probability of phenoconversion to PD
Time frame: study intervals ranging from baseline to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 32832589Buegler M, Harms R, Balasa M, Meier IB, Exarchos T, Rai L, Boyle R, Tort A, Kozori M, Lazarou E, Rampini M, Cavaliere C, Vlamos P, Tsolaki M, Babiloni C, Soricelli A, Frisoni G, Sanchez-Valle R, Whelan R, Merlo-Pich E, Tarnanas I. Digital biomarker-based individualized prognosis for people at risk of dementia. Alzheimers Dement (Amst). 2020 Aug 19;12(1):e12073. doi: 10.1002/dad2.12073. eCollection 2020.
- Background: PubMed 34168269Meier IB, Buegler M, Harms R, Seixas A, Coltekin A, Tarnanas I. Using a Digital Neuro Signature to measure longitudinal individual-level change in Alzheimer's disease: the Altoida large cohort study. NPJ Digit Med. 2021 Jun 24;4(1):101. doi: 10.1038/s41746-021-00470-z.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Panagiotis Vlamos, PhD study chair
Bioinformatics and Human Electrophysiology Laboratory, Department of Informatics, Ionian University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Presymptomatic Disease and Mild Cognitive Impairment, run by Greece 2021 Committee at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Greece, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: baseline to 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04701177, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.