NCT03225144 Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
| NCT ID | NCT03225144 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
| Condition | Frontotemporal Dementia |
| Study Type | OBSERVATIONAL |
| Enrollment | 360 participants |
| Start Date | 2017-10-11 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 360 participants in total. It began in 2017-10-11 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Neurodegenerative disorders can lead to problems in movement or memory. Some can cause abnormal proteins to build up in brain cells. Researchers want to understand whether these diseases have related causes or risk factors. Objective: To test people with movement or thinking and memory problems to see if they are eligible for research studies. Eligibility: People ages 18 and older with a neurodegenerative disorder associated with accumulation of TDP-43 or Tau proteins Design: Participants will have a screening visit. This may take place over 2-3 days. Tests include: Medical history Physical exam Questions about behavior and mood Tests of memory, attention, concentration, and thinking Movement measurement. The speed at which participants can stand up from a chair, tap their finger and foot, and walk a short distance will be measured. Some movements will be videotaped. They will be videotaped while they speak and read a paragraph. Blood tests. This might include genetic testing. Lung and breathing tests MRI. They will lie on a table that slides into a cylinder that takes pictures of the body. Some participants will get a dye through IV. Electromyography. A thin needle will be inserted into the muscles to measure electrical signals. Nerve tests. Small electrodes on the skin record muscle and nerve activity. A small piece of skin may be removed. A skin or blood sample may be taken to create stem cells. Optional lumbar puncture. A needle will be inserted into the space between the bones of the back to collect fluid. If participants are not eligible for current studies, they may be contacted in the future. ...
Eligibility 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.
Contact & Investigator
Justin Y Kwan, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)
Frequently Asked Questions
Who can join the NCT03225144 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 110 Years, studying Frontotemporal Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03225144 currently recruiting?
Yes, NCT03225144 is actively recruiting participants. Contact the research team at carol.hoffman@nih.gov for enrollment information.
Where is the NCT03225144 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT03225144 clinical trial?
NCT03225144 is sponsored by National Institute of Neurological Disorders and Stroke (NINDS). The principal investigator is Justin Y Kwan, M.D. at National Institute of Neurological Disorders and Stroke (NINDS). The trial plans to enroll 360 participants.