Explore Biomarkers of Motor Neuron Disease/Frontal Dementia Spectrum Disease in China

Sponsor

Peking University Third Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04961450

Collaborator

(none)

2,500

Enrollment

Location

114.2

Anticipated Duration (Months)

21.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate the biomarkers of MND/FTD spectrum disease
To explore the possible pathogenesis of MND/FTD

Condition or Disease	Intervention/Treatment	Phase
Amyotrophic Lateral Sclerosis Frontotemporal Dementia Motor Neuron Disease

Detailed Description

Motor neuron disease (MND) is a group of disease characterized by motor neuron disorders and neurodegeneration. MND and frontotemporal dementia (FTD) were believed to comprise a neurodegenerative disease spectrum. The prognosis of the disease spectrum varies according to the type of disease, and the diagnosis of patients is often delayed due to insufficient diagnostic biomarkers. In recent years, the academic community has made significant progress in the study of biomarkers of the disease, but there is still a lack of specific biomarkers with strong diagnostic value. Besides, the low prevalence makes it difficult to carry out studies with large samples. The aim of this study was to explore diagnostic biomarkers of the disease spectrum by collecting variable samples from a large group of patients. The findings will both offer a better understanding of MND/FTD spectrum disease and also support the development of a model to study other rare diseases.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Study on the Biomarkers of Motor Neuron Disease/Frontal Dementia Spectrum Disease in China

Actual Study Start Date :

Jun 24, 2021

Anticipated Primary Completion Date :

Dec 31, 2030

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Patients Inclusion Criteria: Patients aged 18-80 years who visit Peking University Third Hospital, Beijing, China from December 2020. Patients who diagnosis MND/FTD spectrum disease (including ALS, FAS, FLS, PLS, PBP, PMA, FTD, MND-FTD) by an experienced neurologist strictly according to a list of diagnosis criteria and clinical guidelines Informed consent signed Exclusion Criteria Patients who receive alternative diagnoses during the follow-up. Patients who refuse to sign informed consent.
Control Control group consists of individuals matched for gender and age with the patients who are mainly the caregivers of the patients, including but not limited to the patients' spouses and their long-term nurses. Exclusion criteria: Suffering from neurological disease, including but not limited to motor neuron disease/frontotemporal dementia spectrum disease, dementia, Alzheimer's disease, Parkinson's disease, multiple sclerosis, neuromyelitis and so on. Individuals who refuse to sign informed consent.

Arm

Intervention/Treatment

Patients

Inclusion Criteria: Patients aged 18-80 years who visit Peking University Third Hospital, Beijing, China from December 2020. Patients who diagnosis MND/FTD spectrum disease (including ALS, FAS, FLS, PLS, PBP, PMA, FTD, MND-FTD) by an experienced neurologist strictly according to a list of diagnosis criteria and clinical guidelines Informed consent signed Exclusion Criteria Patients who receive alternative diagnoses during the follow-up. Patients who refuse to sign informed consent.

Control

Control group consists of individuals matched for gender and age with the patients who are mainly the caregivers of the patients, including but not limited to the patients' spouses and their long-term nurses. Exclusion criteria: Suffering from neurological disease, including but not limited to motor neuron disease/frontotemporal dementia spectrum disease, dementia, Alzheimer's disease, Parkinson's disease, multiple sclerosis, neuromyelitis and so on. Individuals who refuse to sign informed consent.

Outcome Measures

Primary Outcome Measures

Biomarker differences of the spectrum disease [through study completion, less than 10 years.]
Biomarkers including specific protein, miRNA, DNA , which was obtained by collecting blood, saliva, feces, cerebrospinal fluid, muscle tissue and nerve tissue. The differences of biomarkers between patients and healthy subjects were analyzed statistically in general.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Patients:

Inclusion Criteria:

Patients aged 18-80 years who visit Peking University Third Hospital, Beijing, China from December 2020.

Patients who diagnosis MND/FTD spectrum disease (including ALS, FAS, FLS, PLS, PBP, PMA, FTD, MND-FTD) by an experienced neurologist strictly according to a list of diagnosis criteria and clinical guidelines

Informed consent signed Exclusion Criteria

Patients who receive alternative diagnoses during the follow-up.
Patients who refuse to sign informed consent.

Control group:

Exclusion criteria:

Suffering from neurological disease, including but not limited to motor neuron disease/frontotemporal dementia spectrum disease, dementia, Alzheimer's disease, Parkinson's disease, multiple sclerosis, neuromyelitis and so on.
Individuals who refuse to sign informed consent.