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Alzheimer's DiseaseDNSNCT05153941

Diagnosis and Monitoring of Disease Progression Using Deep Neuro Signatures

An observational study of Alzheimer's Disease and Mild Cognitive Impairment, run by Altoida at 1 site in Greece.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
How many people
3,500 participants
Where
1 siteGreece
Study dates
31 Jan 2022to 31 Jan 2030
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 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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)-).

Who may be able to join

None listed.

Who cannot join

  • 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:
  • 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
Show all 14Show fewer
  • 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
  • 2b. 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

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Nikaia Ag Panteleimon Hospital

    Athens

Other trials in Greece

About this study

Official title: DNS Cohort Study Aimed at Understanding the Pathophysiology of AD and AD Related Disorders (ADRD)

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.

Read the detailed description

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.

Keywords
Alzheimer's Disease, Mild Cognitive Impairment
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05153941
Study groupRoleWhat they receive
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 2Observational 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 years

  2. 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.

    Measured: 5 years

  3. 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.

    Measured: 5 years

  4. 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.

    Measured: 5 years

  5. 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.

    Measured: 5 years

  6. 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.

    Measured: 5 years

  7. 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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2021
  2. Study start31 Jan 2022
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion31 Jan 2030 (estimated)

Resources

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
3,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05153941
Sponsor's protocol ID
4151/19-10-2021
Acronym
DNS
Status last verified
Sep 2025
First submitted
30 Nov 2021
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Narayan VA, Manji HK. Moving from 'diagnose and treat' to 'predict and pre-empt' in neuropsychiatric disorders. Nat Rev Drug Discov. 2016 Feb;15(2):71-2. doi: 10.1038/nrd.2015.20. Epub 2015 Nov 27.

    PubMed 26612665

  • Weintraub S, Carrillo MC, Farias ST, Goldberg TE, Hendrix JA, Jaeger J, Knopman DS, Langbaum JB, Park DC, Ropacki MT, Sikkes SAM, Welsh-Bohmer KA, Bain LJ, Brashear R, Budur K, Graf A, Martenyi F, Storck MS, Randolph C. Measuring cognition and function in the preclinical stage of Alzheimer's disease. Alzheimers Dement (N Y). 2018 Feb 13;4:64-75. doi: 10.1016/j.trci.2018.01.003. eCollection 2018.

    PubMed 29955653

  • Bertens D, Tijms BM, Vermunt L, Prins ND, Scheltens P, Visser PJ. The effect of diagnostic criteria on outcome measures in preclinical and prodromal Alzheimer's disease: Implications for trial design. Alzheimers Dement (N Y). 2017 Sep 21;3(4):513-523. doi: 10.1016/j.trci.2017.08.005. eCollection 2017 Nov.

    PubMed 29124109

  • Jutten RJ, Peeters CFW, Leijdesdorff SMJ, Visser PJ, Maier AB, Terwee CB, Scheltens P, Sikkes SAM. Detecting functional decline from normal aging to dementia: Development and validation of a short version of the Amsterdam IADL Questionnaire. Alzheimers Dement (Amst). 2017 Mar 31;8:26-35. doi: 10.1016/j.dadm.2017.03.002. eCollection 2017.

    PubMed 28462387

  • Koster N, Knol DL, Uitdehaag BM, Scheltens P, Sikkes SA. The sensitivity to change over time of the Amsterdam IADL Questionnaire((c)). Alzheimers Dement. 2015 Oct;11(10):1231-40. doi: 10.1016/j.jalz.2014.10.006. Epub 2015 Jan 15.

    PubMed 25598195

  • Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113. doi: 10.1016/0028-3932(71)90067-4. No abstract available.

    PubMed 5146491

  • Swaminathan A, Jicha GA. Nutrition and prevention of Alzheimer's dementia. Front Aging Neurosci. 2014 Oct 20;6:282. doi: 10.3389/fnagi.2014.00282. eCollection 2014.

    PubMed 25368575

  • Hughes TF, Chang CC, Vander Bilt J, Ganguli M. Engagement in reading and hobbies and risk of incident dementia: the MoVIES project. Am J Alzheimers Dis Other Demen. 2010 Aug;25(5):432-8. doi: 10.1177/1533317510368399.

    PubMed 20660517

  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PubMed 1202204

  • 10. McLeod, D.R., et al., An automated version of the digit symbol substitution test (DSST). Behavior Research Methods & Instrumentation, 1982. 14(5): p. 463-466.

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PubMed 2748771

  • Birchwood M, Smith J, Cochrane R, Wetton S, Copestake S. The Social Functioning Scale. The development and validation of a new scale of social adjustment for use in family intervention programmes with schizophrenic patients. Br J Psychiatry. 1990 Dec;157:853-9. doi: 10.1192/bjp.157.6.853.

    PubMed 2289094

  • Sikkes SA, Knol DL, Pijnenburg YA, de Lange-de Klerk ES, Uitdehaag BM, Scheltens P. Validation of the Amsterdam IADL Questionnaire(c), a new tool to measure instrumental activities of daily living in dementia. Neuroepidemiology. 2013;41(1):35-41. doi: 10.1159/000346277. Epub 2013 May 25.

    PubMed 23712106

  • Galasko D, Bennett D, Sano M, Ernesto C, Thomas R, Grundman M, Ferris S. An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S33-9.

    PubMed 9236950

  • Pedrosa H, De Sa A, Guerreiro M, Maroco J, Simoes MR, Galasko D, de Mendonca A. Functional evaluation distinguishes MCI patients from healthy elderly people--the ADCS/MCI/ADL scale. J Nutr Health Aging. 2010 Oct;14(8):703-9. doi: 10.1007/s12603-010-0102-1.

    PubMed 20922349

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer's Disease and Mild Cognitive Impairment, run by Altoida at 1 site in Greece.

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 0 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. 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?

ADL using selected RMTs (time frame: 5 years). The study lists 7 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 NCT05153941, which also lists 34 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 3 Oct 2025.

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