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Enrolling by invitation NCT04961450

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

Observational Amyotrophic Lateral Sclerosis Frontotemporal Dementia Motor Neuron Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Motor Neuron Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Biomarker differences of the spectrum disease [Time frame: through study completion, less than 10 years.]

Eligibility criteria

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:

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Dongsheng Fan — Beijing

Identifiers

NCT: NCT04961450 · M2020461

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗