Can tracking brain changes over time unlock the secrets of frontotemporal dementia?
NCT ID NCT04363684
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This long-term study follows people with or at genetic risk for frontotemporal lobar degeneration (FTLD), a group of brain disorders that cause changes in behavior, language, and movement. Researchers will use brain scans, memory tests, and blood samples to measure how the disease progresses over time. The goal is to better understand FTLD and identify markers that could help develop future treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this research could lead to better ways to diagnose and track frontotemporal lobar degeneration, and help design future treatments.
- What could go wrong
- This is an observational study, not a treatment trial, so it will not directly provide a cure or therapy. Results may take years to translate into clinical practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 2,100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2020
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants will have a referring diagnosis of an FTLD clinical syndrome or will be a member of a family with a strong family history of an FTLD syndrome.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Longitudinal Arm Inclusion Criteria Familial FTLD (f-FTLD) participants (either is acceptable): * members of families in whom at least one member has a known disease-associated mutation in one of the major genes that cause f-FTLD: MAPT, GRN, C9orf72 (or other rare genes) * an autosomal dominant family history of a FTLD syndrome (without a known gene) verified by medical record review or well-documented family history including family members with a medical history consistent with FTLD or a related disorder. Sporadic FTLD (s-FTLD) participants: Sporadic participants should be symptomatic with no known family history nor a genetic mutation indicating f-FTLD. All sporadic participants must have an FTLD syndrome as a referring diagnosis; those determined by ALLFTD clinicians to have non-FTLD diagnoses will be excluded from longitudinal visits, but their baseline visit will be included in comparative datasets. For inclusion in the longitudinal follow-up, participants should meet research criteria for one of the following FTLD syndromes: * Progressive Supranuclear Palsy (PSP) * Semantic variant Primary Progressive Aphasia (svPPA) * Nonfluent variant Primary Progressive Aphasia (nfvPPA) * Corticobasal Degeneration (CBD)/Corticobasal Syndrome (CBS) * Behavioral variant Frontotemporal dementia (bvFTD) * Frontotemporal Dementia with Amyotrophic Lateral Sclerosis (FTD/ALS) Biofluid-Focused Arm Inclusion Criteria Participants enrolled in the biofluid arm may be either f-FTLD or s-FTLD. All general inclusion criteria apply. Participants should meet research criteria (as specified above) for any FTLD syndrome or meet familial FTLD inclusion criteria. Because the biofluid arm participants do not undergo the same detailed clinical and functional assessments required for the longitudinal arm, participants may be included regardless of primary language, as long as an appropriately translated consent is available. Exclusion Criteria: * Known presence of a structural brain lesion (e.g. tumor, cortical infarct) that could reasonably explain symptoms in a symptomatic participant. * Known presence of an Alzheimer's disease causing mutation in PSEN1, PSEN2 or APP; or biomarker evidence for Alzheimer's disease as a cause of the clinical syndrome. * A previous history of Korsakoff encephalopathy, severe alcohol dependence (within 5 years of onset of dementia), frequent alcohol or other substance intoxication, or other neurological disorder. * Evidence through history or laboratory testing of uncorrected B12 deficiency (B12 \< 95% of local laboratory's normal value), unregulated hypothyroidism (TSH \>150% of normal), HIV positive, renal failure (creatinine \> 2), liver failure (ALT or AST \> two times normal), respiratory failure that requires supplemental oxygen, large confluent white matter lesions, significant systemic medical illnesses such as deteriorating cardiovascular disease. * Current medication likely to affect CNS functions in the opinion of the site PI. * In the site investigator's opinion, the participant cannot complete sufficient key study procedures. The participant may be enrolled into the biofluid-focused arm if they can tolerate a blood draw and short clinical exam, but must be able to complete at least 75% of study procedures for enrollment into the longitudinal arm.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
27 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Case Western Reserve Medical Center
RECRUITINGCleveland, Ohio, 44106, United States
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Cleveland Clinic Lou Ruvo Center for Brain Health
RECRUITINGLas Vegas, Nevada, 89106, United States
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Columbia University
RECRUITINGNew York, New York, 10032, United States
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Emory University
RECRUITINGAtlanta, Georgia, 30322, United States
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Indiana University
RECRUITINGIndianapolis, Indiana, 46202, United States
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Johns Hopkins University
RECRUITINGBaltimore, Maryland, 21287, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Mayo Clinic Florida
RECRUITINGJacksonville, Florida, 32224, United States
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Mayo Clinic Rochester
RECRUITINGRochester, Minnesota, 55905, United States
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Mount Sinai
NOT_YET_RECRUITINGNew York, New York, 10029, United States
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NIH
RECRUITINGBethesda, Maryland, 20814, United States
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Nantz National Alzheimer Center Houston
RECRUITINGHouston, Texas, 77030, United States
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Northwestern University
RECRUITINGChicago, Illinois, 60611, United States
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UT San Antonio Health Science Center
RECRUITINGSan Antonio, Texas, 78229, United States
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University of Alabama Birmingham
RECRUITINGBirmingham, Alabama, 35233, United States
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University of British Columbia
RECRUITINGVancouver, British Columbia, Canada
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University of California San Francisco
RECRUITINGSan Francisco, California, 91358, United States
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University of California, Los Angeles
RECRUITINGLos Angeles, California, 90095, United States
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University of California, San Diego
RECRUITINGSan Diego, California, 92093, United States
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University of Colorado Denver
RECRUITINGDenver, Colorado, 80204, United States
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
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University of North Carolina, Chapel Hill
RECRUITINGChapel Hill, North Carolina, 27514, United States
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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University of Toronto
RECRUITINGToronto, Ontario, Canada
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University of Washington
RECRUITINGSeattle, Washington, 98195, United States
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Vanderbilt University
RECRUITINGNashville, Tennessee, 37235, United States
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Washinton University in St. Louis
RECRUITINGSt Louis, Missouri, 63110, United States
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