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Protocol Details

Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-N-0131

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Motor Neuron Disease;
Frontotemporal Dementia;
Corticobasal Syndrome

Recruitment Keyword(s)

None

Condition(s)

Frontotemporal Lobar Degeneration;
Amytrophic Lateral Sclerosis;
Progressive Supranuclear Palsy

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

Objectives

The primary objective is to screen patients who are referred with a diagnosis of frontotemporal dementia, motor neuron disorder, or related adult-onset neurodegenerative disorder to assess patient eligibility for ongoing protocols. The secondary objective is to develop and maintain a registry of characterized patients who may be eligible for future trials. An exploratory objective is to obtain biospecimens from clinically characterized patients to carry out laboratory-based studies aimed at understanding the molecular pathways and genetic overlap between these neurodegenerative disorders.

Study population

Adults referred with clinical diagnoses of frontotemporal dementia, motor neuron disorder, or related adult-onset neurodegenerative disorder.

Design

Participants will all undergo diagnostic screening tests, a standard battery of tests to measure cognitive and motor function, and blood for clinical testing and research. Additional diagnostic and research testing, including magnetic resonance imaging, electromyography, neuropsychological testing, lumbar puncture, and skin biopsy will be obtained in selected patients.

Outcome measures

Patients will be screened for eligibility for current research protocol or entered into a registry future research protocols

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Eligibility

INCLUSION CRITERIA:

Patients will be included if they

-Are age 18 or older

-Have been given a diagnosis by a neurologist of frontotemporal dementia, frontotemporal lobar degeneration, primary progressive aphasia, semantic dementia, motor neuron disorder, amyotrophic lateral sclerosis, primary lateral sclerosis, progressive bulbar palsy, corticobasal syndrome, Huntington disease or other related adult-onset neurodegenerative Disorder

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Mary Kay Floeter, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Carol H. Hoffman
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 1D45
10 Center Drive
Bethesda, Maryland 20892
(301) 451-1229
carol.hoffman@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03225144

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