Diagnosis and Monitoring of Disease Progression Using Deep Neuro Signatures

NCT05153941 | Active Not Recruiting

• 1 other identifier: 4151/19-10-2021
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer's Disease; Mild Cognitive Impairment

Keywords

Alzheimer's Disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  5 years

Study Arms (2)

Main Study (tier 1)

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

Tier 2

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)-).

You may qualify if:

• 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:
• a. For subjects in the Alzheimer's continuum and those with non-AD pathologic changes, (n=3,110):
• Male or female over 50 years of age.
• Approximately age and gender matched among groups as classified below.
• A study partner (caregiver/family member) is available to collaborate to visit the site together with the subject and give necessary information on the subject.
• Physician's clinical judgement of individuals by classifying into three syndromal stages of cognitive continuum: cognitively unimpaired, mild cognitive impairment, and dementia as described in 2018 NIA-AA research framework \[39\], \[40\] while taking into account of clinical assessment performance such as MMSE and CDR scores. This syndromic staging is applicable to all members of a research cohort independent from biomarker profiles.
• Numeric clinical staging in 2018 NIA-AA research framework may also be applied to cognitive staging in the Alzheimer's continuum \[40\] .
• cognitively unimpaired
• mild cognitive impairment
• mild dementia
• moderate dementia
• severe dementia
• AT(N) biomarker profile as evidenced by CSF test results is combined with the clinical staging for the classification of each subject.
• Aβ biomarker positive subjects without cognitive impairment, those with MCI, and those with dementia are considered as preclinical AD, MCI due to AD, and dementia due to AD, respectively. In case otherwise stated, these nomenclatures are used throughout this study.
• Informed consent signed by the subject and/or study partner.

You may not qualify if:

• 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:
• a. For subjects in the Alzheimer's continuum and those with non-AD pathologic changes:
• Presence of an additional neurological, psychiatric, or chronic disease that may affect ADL, cognitive function or social interactions.
• 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.). MRI assessment should be utilized for verifying those disorders.
• TSH above normal range
• T3 or T4 outside normal range with clinically significant.
• Positive test for SARS-CoV-2 on a nasopharyngeal swab
• Failure to show negative PCR results for Covid19 or proof of vaccination
• b. Healthy volunteer subjects:
• Presence of an additional neurological, psychiatric, or chronic 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.
• Positive test for SARS-CoV-2 on a nasopharyngeal swab
• Failure to show negative PCR results for Covid19 or proof of vaccination

Sponsors & Collaborators

• Altoida: lead
• Eisai Co., Ltd.: collaborator
• Ionian University: collaborator

Study Sites (1)

Nikaia Ag Panteleimon Hospital

Athens, Greece

Location

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Related Links

• Guideline clinical investigation medicines treatment Alzheimer's disease other dementias
• Functional Activities Questionnaire
• European Medicines Agency

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, Blood, and Cerebral Spinal Fluid (CSF) samples will be collected for (a) DNA extraction for ApoE4-allele genotyping and other genetic analyses, (b) metabolic markers, plasma cholesterol and HbA1C level, (c) biomarker analysis and biospecimen banking.

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Sophie Skalidi MD, PhD

  General State Hospital of Nikaia "Saint Panteleimon"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 10, 2021
• Study Start: January 31, 2022
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2030
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)