Recruiting

Observational StudyARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)

Sponsor:

Mayo Clinic

Code:

NCT04363684

Conditions

Frontotemporal Lobar Degeneration (FTLD)

Progressive Supranuclear Palsy (PSP)

Corticobasal Degeneration (CBD)

Behavioral Variant Frontotemporal Dementia (bvFTD)

Semantic Variant Primary Progressive Aphasia (svPPA)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Frontotemporal Lobar Degeneration (FTLD)

Progressive Supranuclear Palsy (PSP)

Corticobasal Degeneration (CBD)

Behavioral Variant Frontotemporal Dementia (bvFTD)

Semantic Variant Primary Progressive Aphasia (svPPA)

Study ID

NCT04363684

Start date

Mar 1, 2020

Status verified date

Jul, 2026

Completion date

Aug 31, 2030

Anticipated

Primary completion date

Aug 31, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

2100 participants

Anticipated

Interventions and Outcome Measures

Arms

Longitudinal Arm

Annual clinic visits throughout the length of the study.

Biofluid-Focused Arm

Single clinic visit.

Primary outcome measure

Change in Brain Volumes [ Time Frame: Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year ]
Change in neuropsychological battery [ Time Frame: Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year ]
Change in Multidomain Impairment Rating (MIR) Scale [ Time Frame: Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year ]

Central Contacts and Locations

Central contacts

Leah K Forsberg, PhD

507-293-9577 forsberg.leah@mayo.edu

Hilary Heuer, PhD

415-476-6743 hilary.heuer@ucsf.edu

Locations

University of Alabama Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Loren Brown

samanthabrown@uabmc.edu

Principal Investigator:

Erik Roberson, MD

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Alexander Sheppard

asheppard@mednet.ucla.edu

Principal Investigator:

Mario Mendez, MD

University of California, San Diego

Recruiting

San Diego, California, United States, 92093

Contacts

Michael Skipworth

mskipworth@health.ucsd.edu

Brandon Pulido

b1pulido@health.ucsd.edu

Principal Investigator:

Irene Litvan, MD

University of California San Francisco

Recruiting

San Francisco, California, United States, 91358

Contacts

Cole Mollard

Cole.Mollard@ucsf.edu

Principal Investigator:

Adam Boxer, MD, Ph.D

University of Colorado Denver

Recruiting

Denver, Colorado, United States, 80204

Contacts

Danelle Carter

DANELLE.CARTER@CUANSCHUTZ.EDU

Principal Investigator:

Ece Bayram, MD

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Kandise Chrestensen

chrestensen.kandise@mayo.edu

Principal Investigator:

Neill Graff-Radford, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Samantha Heldenberg

shelden@emory.edu

Principal Investigator:

Chad Hales, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Northwestern Study Team

clinicaltrials.mesulam@northwestern.edu

Principal Investigator:

Ian Grant, MD

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Ralitsa Kostadinova

rkostad@iu.edu

Principal Investigator:

David Clark, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Ann Fishman

ann.fishman@jhu.edu

Principal Investigator:

Chiadi Onyike, MD, MHS

NIH

Recruiting

Bethesda, Maryland, United States, 20814

Contacts

Carol Hoffman

carol.hoffman@nih.gov

Principal Investigator:

Allison Snyder, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Erin Krahn

ekrahn@mgh.harvard.edu

Principal Investigator:

Brad Dickerson, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Kiren Chaudhry

chaudhki@med.umich.edu

Principal Investigator:

Sami Barmada, MD

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Abbi Osborne

osborne.abigail@mayo.edu

Principal Investigator:

Bradley Boeve, MD

Washinton University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Tina Nolte

nolte.tina@wustl.edu

Principal Investigator:

Nupur Ghoshal, MD, PhD

Cleveland Clinic Lou Ruvo Center for Brain Health

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Ghanen Concepcion

CONCEPG5@ccf.org

Principal Investigator:

Dylan Wint, MD

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Arlene Mejia

am4717@cumc.columbia.edu

Principal Investigator:

Lawrence S Honig, MD

University of North Carolina, Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

UNC ALLFTD Team

ALLFTD@neurology.unc.edu

Principal Investigator:

Andrea Bozoki, MD

Case Western Reserve Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Maria Toth

maria.toth@uhhospitals.org

Principal Investigator:

Brain Appleby, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Jessica Legaspi

jessica.legaspi@pennmedicine.upenn.edu

Principal Investigator:

David Irwin, MD

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37235

Contacts

Jerica Braswell

jerica.braswell@vumc.org

Principal Investigator:

Richard R Darby, MD

Nantz National Alzheimer Center Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Victoria Arbones

varbones@houstonmethodist.org

Principal Investigator:

Belen Pascual, PhD

UT San Antonio Health Science Center

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Crystal Mendoza

mendozac2@uthscsa.edu

Principal Investigator:

A.Campbell Sullivan, PsyD, ABPP

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Alicia Adams

adamsali@uw.edu

Principal Investigator:

Kimiko Domoto-Reilly, MD

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada

Contacts

Jessica Luk

jessica.luk@vch.ca

Rachel Freid

604-827-1050 rachel.freid@uhn.ca

Principal Investigator:

Ging-Yuek Robin Hsiung, MD, MHSc, FRCPC

University of Toronto

Recruiting

Toronto, Ontario, Canada

Contacts

Kasey Cortez

kasey.cortez@uhn.ca

Principal Investigator:

Carmela Tartaglia, MD, FRCPC

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.