Explore Biomarkers of Motor Neuron Dise… | Clinical Trial

Key information

Conditions

Amyotrophic Lateral Sclerosis Brain Diseases Central Nervous System Diseases Dementia Frontotemporal Dementia Frontotemporal Lobar Degeneration Mental Disorders Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dongsheng Fan

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Biomarker differences of the spectrum disease

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2030
Study completion: 2030
First posted: Jul 14, 2021
Registry last updated: Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed