Neurodegenerative Diseases Progression Markers (MARKERS-NDD)

NCT06596746 | Recruiting

• 1 other identifier: 001-2024
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

MARKERS-NDD is a prospective, observational, longitudinal study, which aims to collect data from patients affected by neurodegenerative diseases (NDD) followed longitudinally for routine examinations performed as part of normal clinical practice. Data collected from clinical evaluations, movement analysis, brain imaging, neuropsychological and electroencephalographic assessments, blood chemistry tests will be analysed to carry out statistical investigations and predictive analyses, also using artificial intelligence systems, which allow the identification of new early markers of diagnosis and prognosis of neurodegenerative diseases.

Conditions

Neurodegenerative Diseases; Parkinson Disease; Synucleinopathies; Lewy Body Disease; Multiple System Atrophy; Tauopathies; Alzheimer Disease; Corticobasal Degeneration; Supranuclear Palsy, Progressive; Atypical Parkinsonism; TDP-43 Proteinopathies; Amyotrophic Lateral Sclerosis; Frontotemporal Lobar Degeneration; Movement Disorders; Cognitive Impairment; Dementia; Iron Overload; Neurodegeneration With Brain Iron Accumulation (NBIA)

Keywords

Neurodegenerative Diseases; Markers; Gait analysis; Wearable inertial sensors; IMU; Artificial intelligence; AI-Video gait analysis; Handwriting analysis; Voice-based artificial intelligence systems; imaging; multimodal analysis; electroencephalogram; cortical activity; gut microbiota; laboratory blood chemistry parameters

Outcome Measures

Primary Outcomes (1)

• To monitor and predict the course of neurodegenerative diseases through the study of clinical markers and the creation of AI-models

  To identify markers of neurodegenerative disease progression for use in clinical monitoring

  Baseline to 120 months

Secondary Outcomes (1)

• To predict the risk to develop neurodegenerative diseases through the study of clinical markers and the creation of AI-models

  Baseline to 120 months

Study Arms (2)

Patients with diagnosis of Parkinson's Disease, Parkinsonism and Movement Disorders

Other: Observation

Patients affected by cognitive impairment (CI) and dementia

Other: Observation

Interventions

Observation OTHER

In MARKERS-NDD up to 600 participants will be enrolled and followed longitudinally once identified, over the course of 1-10 years

Patients affected by cognitive impairment (CI) and dementia; Patients with diagnosis of Parkinson's Disease, Parkinsonism and Movement Disorders

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Neurodegerative Diseases

You may qualify if:

• Patients with diagnosis of Parkinson's Disease, Parkinsonism and Movement Disorders
• Patients with diagnosis of Parkinson's Disease
• Diagnosis of Parkinson's Disease according to the United Kingdom (UK) Parkinson's Disease Society Brain Bank
• Diagnosis of Movement Disorder not related to Parkinson's Disease
• Diagnosis of Multiple System Atrophy (MSA) in accordance with Second Consensus Statement on Diagnosis of Multiple System Atrophy;
• Diagnosis of Progressive Supranuclear Palsy according to Movement Disorder Society for Diagnosis of Progressive Supranuclear Palsy;
• Diagnosis of Essential Tremor
• Willing to participate in the study, understand the procedures and sign the informed consent.
• Patients affected by cognitive impairment (CI) and dementia
• Diagnosis of probable:
• Lewy Body Dementia
• Alzheimer's Disease
• Mild Cognitive Decline
• Subjective memory complaints
• Willing to participate in the study, understand the procedures and sign the informed consent.

You may not qualify if:

• There are no restrictions for participation in the study based on age, severity of illness or presence of cognitive impairment, as long as the person is able to complete the research assessments.

Sponsors & Collaborators

• Casa di Cura San Raffaele Cassino: lead
• IRCCS San Raffaele Roma: collaborator
• San Raffaele Telematic University: collaborator
• University of Urbino "Carlo Bo": collaborator
• University of Cassino and Southern Lazio: collaborator
• University of Roma La Sapienza: collaborator
• Politecnico di Milano: collaborator

Study Sites (1)

San Raffaele Cassino

Cassino, Frosinone, 03043, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples for microbiota analysis

MeSH Terms

Conditions

Neurodegenerative Diseases; Parkinson Disease; Synucleinopathies; Lewy Body Disease; Multiple System Atrophy; Tauopathies; Alzheimer Disease; Corticobasal Degeneration; Supranuclear Palsy, Progressive; TDP-43 Proteinopathies; Amyotrophic Lateral Sclerosis; Frontotemporal Lobar Degeneration; Movement Disorders; Cognitive Dysfunction; Dementia; Iron Overload; Pantothenate Kinase-Associated Neurodegeneration

Interventions

Observation

Condition Hierarchy (Ancestors)

Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders; Primary Dysautonomias; Autonomic Nervous System Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Motor Neuron Disease; Neuromuscular Diseases; Cognition Disorders; Iron Metabolism Disorders; Neuroaxonal Dystrophies; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Maria Francesca De Pandis, MD, PhD, Neurologist

CONTACT

0776394740; maria.depandis@sanraffaele.it

Maria Gaglione

CONTACT

0776394740; maria.gaglione@sanraffaele.it

Study Design

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

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: September 19, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): September 9, 2034
• Study Completion (Estimated): September 9, 2034
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IT (1)