Understanding neurodegenerative disorders like ALS and frontotemporal dementia
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
This study is trying to see if adults with neurodegenerative disorders like ALS and frontotemporal dementia can join future research by checking their health and collecting samples for further testing.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT03225144 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate adults diagnosed with neurodegenerative disorders such as frontotemporal dementia and amyotrophic lateral sclerosis to determine their eligibility for further research. Participants will undergo a series of clinical assessments, including medical history, physical exams, cognitive tests, and movement measurements. Additionally, the study seeks to develop a registry of characterized patients and collect biospecimens for laboratory research to explore the molecular pathways and genetic factors associated with these disorders.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of frontotemporal dementia, ALS, or related neurodegenerative disorders.
Not a fit: Patients with other major neurological or medical diseases that could confound results or those unable to travel to the study location may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of neurodegenerative disorders and lead to improved diagnostic and therapeutic strategies for patients.
How similar studies have performed: While there have been studies on neurodegenerative disorders, this specific approach focusing on the genetic and molecular overlap is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: Patients will be included if they * Are age 18 or older * Have been given a diagnosis by a neurologist of frontotemporal dementia, primary progressive aphasia, semantic dementia, motor neuron disorder, amyotrophic lateral sclerosis, progressive bulbar palsy, corticobasal syndrome, Huntington disease or other related adult-onset neurodegenerative disorder OR * Carry a mutation in a gene that causes familial ALS or FTD EXCLUSION CRITERIA: Patients will be excluded if they * Have other major neurological or medical diseases that may cause progressive weakness or cognitive dysfunction, such as structural brain or spinal cord disease, metabolic diseases, paraneoplastic syndromes, infectious diseases, peripheral neuropathy or radiculopathy or other significant neurological abnormalities. * Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe * Require daytime ventilator support at the time of study entry * Are unable to travel to NIH * Patients with pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, or shrapnel fragments, metal fragments in the eye) will not be excluded but will not undergo magnetic resonance imaging. * Patients with tattoos above the neck or permanent make up will be excluded from undergoing 7T MRI.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Justin Y Kwan, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
- Study coordinator: Carol H Hoffman
- Email: carol.hoffman@nih.gov
- Phone: (301) 451-1229
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.