Recruiting

Neurodegenerative Disorders

Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Code:

NCT03225144

Conditions

Frontotemporal Dementia

Amyotrophic Lateral Sclerosis

Progressive Supranuclear Palsy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Frontotemporal Dementia

Amyotrophic Lateral Sclerosis

Progressive Supranuclear Palsy

Study ID

NCT03225144

Start date

Oct 11, 2017

Status verified date

Aug 31, 2026

Completion date

Oct 30, 2027

Anticipated

Primary completion date

Oct 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

360 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients

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

Primary outcome measure

  • Clinical information [ Time Frame: 10/30/2027 ]

Central Contacts and Locations

Central contacts

Carol H Hoffman

(301) 451-1229carol.hoffman@nih.gov

Justin Y Kwan, M.D.

(301) 496-7428justin.kwan@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Last update posted

Sep 2, 2026

Last verified

Aug 31, 2026

Keywords

  • TDP-43
  • Progressive Supranuclear Palsy
  • Motor Neuron Disease
  • Frontotemporal Dementia
  • Corticobasal Syndrome
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Neurological Disorders and Stroke (NINDS) on 2026-09-02.