ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)

March 12, 2024 updated by: Bradley Boeve, Mayo Clinic
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.

Study Overview

Status

Recruiting

Conditions

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/

Study Type

Observational

Enrollment (Estimated)

2100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Recruiting
        • University of British Columbia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ging-Yuek Robin Hsiung, MD, MHSc, FRCPC
        • Principal Investigator:
          • Ian Mackenzie, MD, MSc, LMCC, FRCPC
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • University of Toronto
        • Principal Investigator:
          • Carmela Tartaglia, MD, FRCPC
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama Birmingham
        • Contact:
        • Principal Investigator:
          • Erik Roberson, MD
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles
        • Principal Investigator:
          • Mario Mendez, MD
        • Contact:
      • San Diego, California, United States, 92093
        • Recruiting
        • University of California, San Diego
        • Contact:
        • Principal Investigator:
          • Irene Litvan, MD
        • Principal Investigator:
          • Doug Galasko, MD
        • Principal Investigator:
          • Gabriel Leger, MD
        • Contact:
      • San Francisco, California, United States, 91358
        • Recruiting
        • University of California San Francisco
        • Contact:
        • Principal Investigator:
          • Adam Boxer, MD, Ph.D
        • Principal Investigator:
          • Howard Rosen, MD
    • Colorado
      • Denver, Colorado, United States, 80204
        • Recruiting
        • University of Colorado Denver
        • Contact:
        • Principal Investigator:
          • Peter Pressman, MD
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Florida
        • Contact:
        • Principal Investigator:
          • Neill Graff-Radford, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Contact:
        • Principal Investigator:
          • Chad Hales, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Sandra Weintraub, PhD
        • Contact:
        • Principal Investigator:
          • Ian Grant, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Contact:
        • Principal Investigator:
          • David Clark, MD
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Contact:
        • Principal Investigator:
          • Chiadi Onyike, MD, MHS
      • Bethesda, Maryland, United States, 20814
        • Recruiting
        • NIH
        • Contact:
        • Principal Investigator:
          • Allison Snyder, MD
        • Principal Investigator:
          • Justin Kwan, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Brad Dickerson, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Sami Barmada, MD
    • Minnesota
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washinton University in St. Louis
        • Contact:
        • Principal Investigator:
          • Nupur Ghoshal, MD, PhD
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Cleveland Clinic Lou Ruvo Center for Brain Health
        • Principal Investigator:
          • Dylan Wint, MD
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia Unversity
        • Contact:
        • Principal Investigator:
          • Lawrence S Honig, MD
      • New York, New York, United States, 10029
        • Not yet recruiting
        • Mount Sinai
        • Contact:
        • Principal Investigator:
          • Fanny Elahi
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina, Chapel Hill
        • Principal Investigator:
          • Andrea Bozoki, MD
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve Medical Center
        • Contact:
        • Principal Investigator:
          • Brain Appleby, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Tennessee
      • Nashville, Tennessee, United States, 37235
        • Recruiting
        • Vanderbilt University
        • Contact:
        • Principal Investigator:
          • Richard R Darby, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Nantz National Alzheimer Center Houston
        • Contact:
        • Principal Investigator:
          • Belen Pascual, PhD
        • Principal Investigator:
          • Joseph Masdeu, MD, PhD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • UT San Antonio Health Science Center
        • Contact:
        • Principal Investigator:
          • A.Campbell Sullivan, PsyD, ABPP
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Principal Investigator:
          • Kimiko Domoto-Reilly, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Longitudinal Arm
Annual clinic visits throughout the length of the study.
Biofluid-Focused Arm
Single clinic visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Brain Volumes
Time Frame: Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
Compare rates of change in whole brain and regional volumes between asymptomatic f-FTLD and symptomatic f- and s-FTLD, measured using MRI.
Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
Change in NIH Examiner Executive Composite Score
Time Frame: Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
Evaluate change in NIH Examiner Executive Composite Score in asymptomatic f-FTLD.
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
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.
Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Neurofilament Light Chain Analysis
Time Frame: 5 years
Annual blood samples will be collected to detect changes in plasma neurofilament light chain concentrations
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)
University of California, San Francisco

Investigators

  • Principal Investigator: Adam Boxer, MD, PhD, University of California, San Francisco
  • Principal Investigator: Howie Rosen, MD, University of California, San Francisco
  • Principal Investigator: Bradley Boeve, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 2, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-004543
  • U19AG063911 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified subject level data will be shared upon approved data request.

IPD Sharing Time Frame

De-identified data will be available for at least the duration of the study.

IPD Sharing Access Criteria

Interested researchers must complete a data request through the ALLFTD website. All data requests will be reviewed by a committee for evaluation of scientific merit and feasibility. Please consult the website for additional information regarding this process (https://www.allftd.org/policies).

Approved requests will be delivered in a de-identified manner.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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