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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Frontotemporal Dementia

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 Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Dongsheng Fan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

MND/FTD patients in China

Description

Patients:

Inclusion Criteria:

1. 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

2. Informed consent signed Exclusion Criteria

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

Control group:

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:

1. 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.
2. Individuals who refuse to sign informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker differences of the spectrum disease	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.	through study completion, less than 10 years.

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2021
• Primary Completion (Anticipated): December 31, 2030
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: M2020461

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No