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NCT04363684RecruitingAccepts Healthy Volunteers

ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)

Mayo Clinic

Start Date

3/1/2020

Completion Date

8/31/2030

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.

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/

Eligibility Criteria

Age Range: 18 years to No maximum

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.

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Conditions

Frontotemporal Lobar Degeneration (FTLD)Progressive Supranuclear Palsy (PSP)Corticobasal Degeneration (CBD)Behavioral Variant Frontotemporal Dementia (bvFTD)Semantic Variant Primary Progressive Aphasia (svPPA)Nonfluent Variant Primary Progressive Aphasia (nfvPPA)FTD With Amyotrophic Lateral Sclerosis (FTD/ALS)Amyotrophic Lateral SclerosisOligosymptomatic PSP (oPSP)C9orf72GRN Related Frontotemporal DementiaMAPT Gene MutationTBK1 Gene MutationOligosymptomatic Progressive Supranuclear Palsy

Locations

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