Clinical trial NCT04961450: Explore Biomarkers of Motor Neuron Disease/Frontal Dementia Spectrum Disease in China
Official title: A Study on the Biomarkers of Motor Neuron Disease/Frontal Dementia Spectrum Disease in China
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Amyotrophic Lateral Sclerosis
Frontotemporal Dementia
Motor Neuron Disease
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MND/FTD patients in China

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biomarker differences of the spectrum disease
timeFrame: through study completion, less than 10 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongsheng Fan
state: Beijing
Study officials:
References: