ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)
NCT ID: NCT04363684
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2100 participants
OBSERVATIONAL
2020-03-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Longitudinal Arm
Annual clinic visits throughout the length of the study.
No interventions assigned to this group
Biofluid-Focused Arm
Single clinic visit.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
National Institute on Aging (NIA)
NIH
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Mayo Clinic
OTHER
Responsible Party
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Bradley Boeve
Principal Investigator
Principal Investigators
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Bradley Boeve, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Adam Boxer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Howie Rosen, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
University of California, Los Angeles
Los Angeles, California, United States
University of California, San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
University of Colorado Denver
Denver, Colorado, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
NIH
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washinton University in St. Louis
St Louis, Missouri, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States
Mount Sinai
New York, New York, United States
Columbia University
New York, New York, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Case Western Reserve Medical Center
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
Nantz National Alzheimer Center Houston
Houston, Texas, United States
UT San Antonio Health Science Center
San Antonio, Texas, United States
University of Washington
Seattle, Washington, United States
University of British Columbia
Vancouver, British Columbia, Canada
University of Toronto
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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ALLFTD Study Website
Other Identifiers
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19-004543
Identifier Type: -
Identifier Source: org_study_id
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