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Longitudinal study of frontotemporal lobar degeneration

ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)

Observational Mayo Clinic · NCT04363684

This study is trying to learn more about frontotemporal lobar degeneration by following both affected individuals and their family members over time to see how the condition develops.

Quick facts

Study typeObservational
Enrollment2100 (estimated)
Ages18 Years and up
SexAll
SponsorMayo Clinic Academic / other
Locations27 sites (Birmingham, Alabama and 26 other locations)
Trial IDNCT04363684 on ClinicalTrials.gov

What this trial studies

The ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) study aims to evaluate both sporadic and familial cases of frontotemporal lobar degeneration (FTLD) and asymptomatic family members of affected individuals. It features two arms: a longitudinal arm that conducts comprehensive annual assessments of clinical, functional, imaging, and biofluid data, and a biofluid-focused arm that collects biospecimens with limited clinical data. This integrated approach seeks to characterize these cohorts over time and inform future clinical trial designs.

Who should consider this trial

Good fit: Ideal candidates include individuals with either sporadic FTLD or familial FTLD with known genetic mutations, as well as asymptomatic family members of affected individuals.

Not a fit: Patients with non-FTLD diagnoses or those without a family history of FTLD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of FTLD and lead to improved diagnostic and therapeutic strategies for patients.

How similar studies have performed: Previous studies have shown promise in understanding FTLD through longitudinal assessments, making this approach both relevant and potentially impactful.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Frontotemporal Lobar DegenerationProgressive Supranuclear PalsyCorticobasal DegenerationBehavioral Variant Frontotemporal DementiaSemantic Variant Primary Progressive AphasiaNonfluent Variant Primary Progressive AphasiaFTD With Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.