NCT04858893

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
562

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

3.1 years

First QC Date

April 21, 2021

Last Update Submit

May 11, 2021

Conditions

Outcome Measures

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

    30 minuts

Study Arms (2)

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

Health ControlsSubjects affected from Parkinsonims

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • a) any focal brain lesion detected with brain imaging studies (CT or MRI); b) diagnosis of clinically relevant 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Moriggia Pelascini" Hospital

Gravedona E Uniti, Como, 22015, Italy

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Parkinson DiseaseParkinson Disease, SecondaryMultiple System AtrophySupranuclear Palsy, Progressive

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesPrimary DysautonomiasAutonomic Nervous System DiseasesOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2021

First Posted

April 26, 2021

Study Start

January 1, 2017

Primary Completion

February 1, 2020

Study Completion

August 31, 2020

Last Updated

May 12, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations