ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)
2 other identifiers
observational
2,100
2 countries
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 2, 2020
CompletedFirst Posted
Study publicly available on registry
April 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
July 11, 2025
July 1, 2025
6.3 years
April 2, 2020
July 8, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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.
Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
Change in NIH Examiner Executive Composite Score
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
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 Outcomes (1)
Plasma Neurofilament Light Chain Analysis
5 years
Study Arms (2)
Longitudinal Arm
Annual clinic visits throughout the length of the study.
Biofluid-Focused Arm
Single clinic visit.
Eligibility Criteria
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.
You may qualify if:
- 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:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- University of California, San Franciscocollaborator
- National Institute on Aging (NIA)collaborator
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
Study Sites (27)
University of Alabama Birmingham
Birmingham, Alabama, 35233, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
University of California, San Diego
San Diego, California, 92093, United States
University of California San Francisco
San Francisco, California, 91358, United States
University of Colorado Denver
Denver, Colorado, 80204, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
NIH
Bethesda, Maryland, 20814, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Washinton University in St. Louis
St Louis, Missouri, 63110, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106, United States
Mount Sinai
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Case Western Reserve Medical Center
Cleveland, Ohio, 44106, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University
Nashville, Tennessee, 37235, United States
Nantz National Alzheimer Center Houston
Houston, Texas, 77030, United States
UT San Antonio Health Science Center
San Antonio, Texas, 78229, United States
University of Washington
Seattle, Washington, 98195, United States
University of British Columbia
Vancouver, British Columbia, Canada
University of Toronto
Toronto, Ontario, Canada
Related Publications (1)
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.
PMID: 35790423DERIVED
Related Links
Biospecimen
DNA, RNA, plasma, serum, PBMC, CSF (CSF is optional)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bradley Boeve, MD
Mayo Clinic
- PRINCIPAL INVESTIGATOR
Adam Boxer, MD, PhD
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Howie Rosen, MD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 2, 2020
First Posted
April 27, 2020
Study Start
March 1, 2020
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
July 11, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- De-identified data will be available for at least the duration of the study.
- 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.
De-identified subject level data will be shared upon approved data request.