ClinicalTrials.gov record NCT04363684

ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old and older
SexAll
LocationCanada, United States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

ALLFTD is a North American observational study that follows people with sporadic or familial frontotemporal lobar degeneration and asymptomatic family members. It has a longitudinal arm with annual, comprehensive clinical, imaging, and biofluid assessments and a biofluid-focused arm with a single visit for specimen collection. The study aims to characterize disease-related changes over time to inform future research and trials.

What it is studying. The study is measuring how symptoms, brain structure on MRI, cognitive and functional scores, and blood biomarkers change over time in people with symptomatic FTLD, familial FTLD, and in asymptomatic family members.

What the researchers hope to learn. To measure rates of change in whole-brain and regional brain volumes, annual change on the Multidomain Impairment Rating (MIR) scale, and longitudinal changes in plasma neurofilament light chain concentrations.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) represents the formalized integration of ARTFL (U54 NS092089; funded through 2019) and LEFFTDS (U01 AG045390; funded through 2019) as a single North American research consortium to study FTLD for 2019 and beyond.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

The ARTFL LEFFTDS Longitudinal Frontotemporal Dementia (ALLFTD) study aims to evaluate sporadic (s-) and familial (f-) frontotemporal lobar degeneration (FTLD) patients and asymptomatic family members of f-FTLD patients, characterizing the cohorts longitudinally and informing clinical trial design. The study has two arms: a "longitudinal arm" involving a comprehensive assessment of clinical, functional, imaging, and biofluid data collection annually, and a "biofluid-focused arm" involving limited clinical data to accompany biospecimen collection. For more information: https://www.allftd.org/

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

In the longitudinal arm, participants have yearly clinic visits with detailed clinical and functional assessments, brain MRI scans, and collection of blood and other biospecimens (baseline and annually, up to several years). The biofluid-focused arm involves a single clinic visit with blood and biospecimen collection and limited clinical data. Annual blood samples include testing such as plasma neurofilament light chain; MRI scans are used to measure brain volumes at baseline and yearly timepoints. Participants must be able to complete most study procedures to join the longitudinal arm; if not, they may be eligible for the shorter biofluid-focused visit.

How the study is structured. A prospective observational cohort study with two participant groups: a longitudinal arm involving yearly comprehensive clinic visits (clinical exams, imaging, and biosample collection) and a biofluid-focused arm involving a single clinic visit centered on biospecimen collection and limited clinical data.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Canada, United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on progressive supranuclear palsy

Clinical trials45 trials listed for progressive supranuclear palsyEvery trial the registry lists for progressive supranuclear palsy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in progressive supranuclear palsy researchLatest monthly update: September 2026. Includes: PSP vs Parkinsons. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Mar 1, 2020
Primary completion
Aug 31, 2030 (estimated)
Study completion
Aug 31, 2030 (estimated)
Target enrollment
2100 participants (estimated)
Last updated on registry
Oct 7, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Mayo Clinic
Principal investigator
Bradley Boeve, Principal Investigator
Mayo Clinic
Collaborators
  • University of California, San Francisco
  • National Institute on Aging (NIA)
  • National Institute of Neurological Disorders and Stroke (NINDS)

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (26)

  • University of Alabama BirminghamRecruiting

    Birmingham, Alabama, 35233 · United States

  • University of California, Los AngelesRecruiting

    Los Angeles, California, 90095 · United States

  • University of California, San DiegoRecruiting

    San Diego, California, 92093 · United States

  • University of California San FranciscoRecruiting

    San Francisco, California, 91358 · United States

  • University of Colorado DenverRecruiting

    Denver, Colorado, 80204 · United States

  • Mayo Clinic FloridaRecruiting

    Jacksonville, Florida, 32224 · United States

  • Emory UniversityRecruiting

    Atlanta, Georgia, 30322 · United States

  • Northwestern UniversityRecruiting

    Chicago, Illinois, 60611 · United States

  • Indiana UniversityRecruiting

    Indianapolis, Indiana, 46202 · United States

  • Johns Hopkins UniversityRecruiting

    Baltimore, Maryland, 21287 · United States

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
biomarker
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
clinical trial
A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
biospecimen
A collection of biological samples, such as blood or tissue, stored with medical information so that researchers can study them later.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials