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Clinical studies to elucidate the molecular mechanisms associated with the pathogenesis of amyotrophic lateral sclerosis (ALS) and to identify effective drug targets

Clinical studies to elucidate the molecular mechanisms associated with the pathogenesis of amyotrophic lateral sclerosis (ALS) and to identify effective drug targets - Clinical research to elucidate ALS pathogenesis and to identify drug targets

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000051823
Enrollment
600
Registered
2023-08-07
Start date
2023-01-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic lateral sclerosis

Interventions

None listed

Sponsors

Keio University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subjects will be who visit Keio University Hospital from the date the study is approved to September 30, 2032 and who are willing to actively participate in this study, consisting of ALS patients (including suspected cases), patients with other neurodegenerative diseases including spinal muscular atrophy, primary lateral sclerosis, spinal and bulbar muscular atrophy(SBMA), Hirayama disease, spinocerebellar degeneration, Alzheimer's disease, dementia with Lewy bodies, Parkinson's disease, basal ganglia syndrome, frontotemporal dementia, Parkinson's disease, basal ganglia syndrome and frontotemporal dementia, patients with other diseases including multiple sclerosis, cerebrovascular disease, myasthenia gravis, neuropathy, myositis, paraneoplastic syndrome, hydrocephalus, traumatic brain and spinal cord injury, spinal cord diseases including cervical myelopathy, encephalomyelitis, brain tumor, spinal tumor, myelopathy, non-spinal cord tumors, and cavernous sinus disease), patients with non-neurological diseases, and healthy subjects. The age of eligibility is limited to 18 years of age or older. If it is difficult to obtain consent from the research subject him/herself due to physical or mental disability at the time of obtaining consent, consent may be obtained from a substitute who is objectively judged to be able to represent the subject's will and interests, and the subject will be enrolled after obtaining written consent on behalf of the subject by the substitute. Even if the research subject is capable of decision-making and normal judgment and has indicated his/her willingness to consent to this research, but the subject has difficulty giving a signature on the consent form due to physical or mental disability, he/she will be selected and enrolled as a research subject by obtaining a written consent form from a surrogate.

Exclusion criteria

Exclusion criteria: The case when the subject does not agree to participate in this study.

Design outcomes

Primary

MeasureTime frame
1) Clinical symptoms Clinical information (vital signs, i.e., height, weight, blood pressure, pulse, consciousness, and respiratory status, as well as personality and mood assessment) obtained during outpatient and inpatient examinations at departments including the Department of Neurology at Keio University Hospital. The information is obtained by interview about decision making regarding life extension and treatment options and family history, visual examination, palpation, percussion, and neurological findings including manual muscle strength test. 2) ALS Severity Scale (revised ALSFRS), Muscle Strength Rating Scale, Higher Functioning Rating Scale, Quality of Life Rating Scale, ADL Rating Scale 3) Related images that are judged to be necessary for normal medical care including CT images of the head and whole body, screening imaging tests for related diseases using isotopes, head MRI and other images including MRA, MRS, and SPECT images to evaluate cerebral blood flow. Clinical examination results commonly performed during medical care and examination process including blood sampling and cerebrospinal fluid sampling. Results of electrophysiological tests including nerve conduction studies, needle electromyography, and other tests of evoked potentials induced by electrical and magnetic stimulation methods, and results of other ALS-related physiological function tests including evaluations of respiratory, cardiac, and swallowing functions. 4) Sample analysis data Various data obtained by molecular biological methods

Countries

Japan

Contacts

Public ContactYoshinori Nishimoto

Keio University School of Medicine Department of Neurology

ynishimo@keio.jp+81-3-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026