ClinicalTrials.gg
CompletedNCT04858893CoMDA-ML-PUpdated May 12, 2021

Application of Machine Learning Method in Validation of Screening Cognitive Test for Parkinsonisms

An observational study in Primary Parkinsonism, Secondary Vascular Parkinson Disease and Multiple System Atrophy, sponsored by Ospedale Generale Di Zona Moriggia-Pelascini. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2021-05-12.

Sponsored by Ospedale Generale Di Zona Moriggia-Pelascini · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
562
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 23 studies in Parkinson Disease by Ospedale Generale Di Zona Moriggia-Pelascini — none open to participants now, none under way, none of them phase 3. Parkinson Disease · Ospedale Generale Di Zona Moriggia-Pelascini.

Enrollment
Largest of 10
562 · median 80
Started
2017
with 4 others
Observational
10 of 23
none open now
Registered
22nd of 23
by date

Among the 23 studies in Parkinson Disease by Ospedale Generale Di Zona Moriggia-Pelascini, this one has the largest enrollment of the 10 observational ones that give a count, is one of 5 that started in 2017, is one of 10 observational ones, and was the 22nd registered.

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

Browse Parkinson Disease studies →

Open to participants now

None of the 23 studies in Parkinson Disease by Ospedale Generale Di Zona Moriggia-Pelascini is open now.

Where they have run

Who these studies take

Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.

This study: all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Download CSVNarrow it in search →With an account: the 23 studies in Parkinson Disease by Ospedale Generale Di Zona Moriggia-Pelascini as a file.
02

Study summary

Based on a prospectively collected data analysis, a new tool, namely CoMDA (Cognition in Movement Disorders Assessment) is developed by merging each item of Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and Frontal Assessment Battery (FAB). A machine learning, able to classify the cognitive profile and predict patients' at risk of dementia, is created.

Read the detailed description

A prospectively data-base was setting up, collecting CoMDA and in-depht-neuropsychologocal-battery scores, obtained from the evaluation of 500 patients with parkinsonisms. Data were analyzed to compare the classification of patient cognition profile, obtained with CoMDA, MMSE, MoC and FAB, with that obtained from in-depth neuropsychological evaluation. A very high percentage of false negative emerged, for MMSE, MoCA and FAB. Conversely, the CoMDA score significantly reduces the rate of false negative.

This new tool, namely "CoMDA" (Cognition in Movement Disorders Assessment), was composed, by merging each item of Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and Frontal Assessment Battery (FAB). Moreover, we created a machine learning, namely "Neural Net 91classification" able to classify the cognitive profile and predict patients' at risk of dementia, providing a prediction of the findings resulting from a in-depht neuropsychological evaluation.

CoMDA and the related Neural Net 91classification represent a reliable, time-sparing screening instrument, which is much more powerful of other common, widely-adopted tools.

03

Conditions studied

  • Primary Parkinsonism
  • Secondary Vascular Parkinson Disease
  • Multiple System Atrophy
  • Supranuclear Palsy, Progressive
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

500 subjects suffering from different forms of Parkinson Disease or Atypical Parkinsonims Syndorme and 61 Helathy Controls

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria (Postuma et al. 2015); b) diagnosis of PSP according to the MDS clinical diagnostic criteria (Höglinger et al. 2017); c) diagnosis of MSA according to the second diagnostic consensus statement (Gilman et al. 2008); d) diagnosis of VP according to Zijlmans et al (Zijlmans et al. 2004).

Exclusion criteria

Exclusion Criteria:

a) any focal brain lesion detected with brain imaging studies (CT or MRI); b) diagnosis of psychiatric disorders, psychosis (evaluated with Neuropsychiatric Inventory) and/or delirium; c) diagnosis of dementia or MCI; d) diagnosis of neurological diseases other than PD or atypical parkinsonian syndromes; e) other medical conditions negatively affecting the cognitive status; f) disturbing resting and/or action tremor, corresponding to scores 2-4 in the specific items of MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III, such as to affect the psychometric evaluation; g) disturbing dyskinesia, corresponding to scores 2-4 in the specific items of MDS-UPDRS III, such as to affect the psychometric evaluation; h) auditory and/or visual dysfunctions impairing the patient´s ability to perform cognitive tests.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
562 participants (actual)
Patient registry
No

Groups and cohorts

  • Subjects affected from Parkinsonims

    Scores of MMSE, FAB MoCA were summarized to calculate the CoMDA scores, than they were used to develop the Neural Net 91 classificator

    Diagnostic Test: CoMDA associated with Neural Net 91 classificator

  • Health Controls

    CoMDA was administered and total score was calculate to develop the Neural Net 91 classificator

    Diagnostic Test: CoMDA associated with Neural Net 91 classificator

Interventions

  • Diagnostic testCoMDA associated with Neural Net 91 classificator
06

What researchers measure

Primary outcomes

  1. Neural Net 91 classificator from CoMDA score

    prediction of cognitive level obtained from the application of Neural Net 91 classificator at CoMDA score

    Time frame: 30 minuts

07

Study locations

1 site
  • "Moriggia Pelascini" Hospital
    Gravedona E Uniti, Como 22015, Italy
08

References and documents

Publications

  • Ortelli P, Ferrazzoli D, Versace V, Cian V, Zarucchi M, Gusmeroli A, Canesi M, Frazzitta G, Volpe D, Ricciardi L, Nardone R, Ruffini I, Saltuari L, Sebastianelli L, Baranzini D, Maestri R. Optimization of cognitive assessment in Parkinsonisms by applying artificial intelligence to a comprehensive screening test. NPJ Parkinsons Dis. 2022 Apr 11;8(1):42. doi: 10.1038/s41531-022-00304-z. PubMed 35410449 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in Feb 2020, 37 months.

Of 378 non-industry observational studies under Parkinson Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 133. This study's 37 months is below that.

Counting every sponsor, half of 438 studies reached it within 47 months; a quarter within 22 and three quarters within 114.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 21, 2021
First posted
Apr 26, 2021
StartActual
Jan 1, 2017
Primary completionActual
Feb 1, 2020
CompletionActual
Aug 31, 2020
Last update
May 12, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04858893
Lead sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
Collaborators
Ospedale di Vipiteno-Sterzing (SABES-ASDAA)
Responsible party
Sponsor
First posted
Apr 26, 2021
Start date
Jan 1, 2017
Primary completion
Feb 1, 2020
Completion
Aug 31, 2020
Last update
May 12, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion