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Frontotemporal Lobar Degeneration (FTLD)NCT04363684

ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)

An observational study of Frontotemporal Lobar Degeneration (FTLD) and Progressive Supranuclear Palsy (PSP), run by Mayo Clinic at 26 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
2,100 participants
Where
26 sitesin 2 countries
Study dates
1 Mar 2020to 31 Aug 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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.

Who may be able to join

None listed.

Who cannot join

  • 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.

Trial locations and contacts

26 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Leah K Forsberg, PhD contact

507-293-9577

forsberg.leah@mayo.edu

Hilary Heuer, PhD contact

415-476-6743

hilary.heuer@ucsf.edu

26 sites in 2 countries

United States24 sites, 24 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Kiren Chaudhry, chaudhki@med.umich.edu

    Sami Barmada, MD

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Courtney Williams, courtney.k.williams@emory.edu

    Chad Hales, MD

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Fiona Sweeney, fsweene4@jh.edu

    Chiadi Onyike, MD, MHS

    Recruiting

  • NIH

    Bethesda, Maryland, 20814

    Carol Hoffman, carol.hoffman@nih.gov

    Allison Snyder, MD

    Recruiting

  • University of Alabama Birmingham

    Birmingham, Alabama, 35233

    Loren Brown, samanthabrown@uabmc.edu

    Erik Roberson, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Erin Krahn, ekrahn@mgh.harvard.edu

    Brad Dickerson, MD

    Recruiting

  • University of North Carolina, Chapel Hill

    Chapel Hill, North Carolina, 27514

    UNC ALLFTD Team, ALLFTD@neurology.unc.edu

    Andrea Bozoki, MD

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Northwestern Study Team, clinicaltrials.mesulam@northwestern.edu

    Ian Grant, MD

    Recruiting

  • Case Western Reserve Medical Center

    Cleveland, Ohio, 44106

    Maria Toth, maria.toth@uhhospitals.org

    Brain Appleby, MD

    Recruiting

  • University of Colorado Denver

    Denver, Colorado, 80204

    Danelle Carter, DANELLE.CARTER@CUANSCHUTZ.EDU

    Ece Bayram, MD

    Recruiting

  • Nantz National Alzheimer Center Houston

    Houston, Texas, 77030

    Victoria Arbones, varbones@houstonmethodist.org

    Belen Pascual, PhD

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Sarah Hutchens, saradavi@iu.edu

    David Clark, MD

    Recruiting

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

    Kandise Chrestensen, chrestensen.kandise@mayo.edu

    Neill Graff-Radford, MD

    Recruiting

  • University of California, Los Angeles

    Los Angeles, California, 90095

    Nixa Starr, NStarr@mednet.ucla.edu

    Mario Mendez, MD

    Recruiting

  • Vanderbilt University

    Nashville, Tennessee, 37235

    Levi Pettit, levi.f.pettit@vumc.org

    Richard R Darby, MD

    Recruiting

  • Mount Sinai

    New York, New York, 10029

    Anna Torten Rabinowitz, tortenrabinowitz.anna@mssm.edu

    Fanny Elahi

    Not yet recruiting

  • Columbia University

    New York, New York, 10032

    Arlene Mejia, am4717@cumc.columbia.edu

    Lawrence S Honig, MD

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Jessica Legaspi, jessica.legaspi@pennmedicine.upenn.edu

    David Irwin, MD

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Abbi Osborne, osborne.abigail@mayo.edu

    Bradley Boeve, MD

    Recruiting

  • UT San Antonio Health Science Center

    San Antonio, Texas, 78229

    Crystal Mendoza, mendozac2@uthscsa.edu

    A.Campbell Sullivan, PsyD, ABPP

    Recruiting

  • University of California, San Diego

    San Diego, California, 92093

    Michael Skipworth, mskipworth@health.ucsd.edu

    Brandon Pulido, b1pulido@health.ucsd.edu

    Recruiting

  • University of California San Francisco

    San Francisco, California, 91358

    Cole Mollard, Cole.Mollard@ucsf.edu

    Adam Boxer, MD, Ph.D

    Recruiting

  • University of Washington

    Seattle, Washington, 98195

    Alicia Adams, adamsali@uw.edu

    Kimiko Domoto-Reilly, MD

    Recruiting

  • Washinton University in St. Louis

    St Louis, Missouri, 63110

    Tina Nolte, nolte.tina@wustl.edu

    Nupur Ghoshal, MD, PhD

    Recruiting

Other trials in United States

Canada2 sites, 2 recruiting

  • University of Toronto

    Toronto, Ontario

    Kasey Cortez, kasey.cortez@uhn.ca

    Carmela Tartaglia, MD, FRCPC

    Recruiting

  • University of British Columbia

    Vancouver, British Columbia

    Jessica Luk, jessica.luk@vch.ca

    Rachel Freid, 604-827-1050, rachel.freid@uhn.ca

    Recruiting

Other trials in Canada

About this study

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.

Read the detailed description

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/

Medical subject headings
Frontotemporal Lobar Degeneration, Supranuclear Palsy, Progressive, Corticobasal Degeneration, Amyotrophic Lateral Sclerosis, Frontotemporal Dementia With Motor Neuron Disease, Frontotemporal Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04363684
Study groupRoleWhat they receive
Longitudinal ArmAnnual clinic visits throughout the length of the study.
Biofluid-Focused ArmSingle clinic visit.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Brain Volumes

    Compare rates of change in whole brain and regional volumes between asymptomatic f-FTLD and symptomatic f- and s-FTLD, measured using MRI.

    Measured: Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year

  2. Change in neuropsychological battery

    Evaluate change in performance on a neuropsychological battery in asymptomatic f-FTLD as well as symptomatic f-FTLD and s-FTLD.

    Measured: Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year

  3. Change in Multidomain Impairment Rating (MIR) Scale

    Annual change in MIR score (total score 0-3), which is a new global scale for FTLD that incorporates behavioral, cognitive, and motor dysfunction in the rating.

    Measured: Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year

Secondary outcomes (1)

  1. Plasma Neurofilament Light Chain Analysis

    Annual blood samples will be collected to detect changes in plasma neurofilament light chain concentrations

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2020
  2. Study start1 Mar 2020
  3. Primary completion31 Aug 2030 (estimated)
  4. Study completion31 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04363684
Sponsor's protocol ID
19-004543
Other IDs
U19AG063911
Status last verified
Oct 2026
First submitted
2 Apr 2020
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified subject level data will be shared upon approved data request.

Publications

  • Tipton PW, Deutschlaender AB, Savica R, Heckman MG, Brushaber DE, Dickerson BC, Gavrilova RH, Geschwind DH, Ghoshal N, Graff-Radford J, Graff-Radford NR, Grossman M, Hsiung GR, Huey ED, Irwin DJ, Jones DT, Knopman DS, McGinnis SM, Rademakers R, Ramos EM, Forsberg LK, Heuer HW, Onyike C, Tartaglia C, Domoto-Reilly K, Roberson ED, Mendez MF, Litvan I, Appleby BS, Grant I, Kaufer D, Boxer AL, Rosen HJ, Boeve BF, Wszolek ZK; ALLFTD Consortium. Differences in Motor Features of C9orf72, MAPT, or GRN Variant Carriers With Familial Frontotemporal Lobar Degeneration. Neurology. 2022 Sep 13;99(11):e1154-e1167. doi: 10.1212/WNL.0000000000200860. Epub 2022 Jul 5.

    PubMed 35790423

Questions about this trial

What is this clinical trial studying?

An observational study of Frontotemporal Lobar Degeneration (FTLD) and Progressive Supranuclear Palsy (PSP), run by Mayo Clinic at 26 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Leah K Forsberg, PhD (507-293-9577, forsberg.leah@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Brain Volumes (time frame: Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04363684, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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