ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)

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Study Purpose:

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 Status:

Recruiting

Disease:

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 Sclerosis , Oligosymptomatic PSP (oPSP) , C9orf72 , GRN Related Frontotemporal Dementia , MAPT Gene Mutation , TBK1 Gene Mutation , Oligosymptomatic Progressive Supranuclear Palsy

Study Type:

Observational

Type of Intervention:

N/A

Intervention Name:

N/A

Placebo:

N/A

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

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

Clinicaltrials.gov ID:

NCT04363684

Neals Affiliated?

No

Coordinating Center Contact Information

Mayo Clinic

Leah K Forsberg, PhD / email hidden; JavaScript is required / 507-293-9577

United States

Full Study Summary:

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 Sponsor:

Mayo Clinic

Estimated Enrollment:

2100

Estimated Study Start Date:

03 / 01 / 2020

Estimated Study Completion Date:

07 / 01 / 2024

Posting Last Modified Date:

05 / 12 / 2023

Date Study Added to neals.org:

04 / 27 / 2020

Minimum Age:

18 Years

Maximum Age:

N/A

Can participants use Riluzole?

Yes

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.

University of Alabama Birmingham | Recruiting

Loren Brown / email hidden; JavaScript is required

Principal Investigator : Erik Roberson, MD

Birmingham, Alabama 35233
United States

University of California, Los Angeles | Recruiting

Kelsey Holiday / email hidden; JavaScript is required

Principal Investigator : Mario Mendez, MD

Los Angeles, California 90095
United States

University of California, San Diego | Recruiting

Michael Skipworth / email hidden; JavaScript is required

Ivonne Arias / email hidden; JavaScript is required

Principal Investigator : Gabriel Leger, MD

San Diego, California 92093
United States

University of California San Francisco | Recruiting

Dilanaz Unal / email hidden; JavaScript is required

Principal Investigator : Howard Rosen, MD

San Francisco, California 91358
United States

University of Colorado Denver | Recruiting

Danelle Carter / email hidden; JavaScript is required

Principal Investigator : Peter Pressman, MD

Denver, Colorado 80204
United States

Mayo Clinic Florida | Recruiting

Kandise Chrestensen / email hidden; JavaScript is required

Principal Investigator : Neill Graff-Radford, MD

Jacksonville, Florida 32224
United States

Emory University | Not yet recruiting

Samantha Heldenberg / email hidden; JavaScript is required

Principal Investigator : Chad Hales, MD

Atlanta, Georgia 30322
United States

Northwestern University | Recruiting

Caila Ryan / email hidden; JavaScript is required

Principal Investigator : Sandra Weintraub, PhD

Chicago, Illinois 60611
United States

Indiana University | Recruiting

Ralitsa Kostadinova / email hidden; JavaScript is required

Principal Investigator : David Clark, MD

Indianapolis, Indiana 46202
United States

Johns Hopkins University | Recruiting

Ann Fishman / email hidden; JavaScript is required

Principal Investigator : Chiadi Onyike, MD, MHS

Baltimore, Maryland 21287
United States

NIH | Not yet recruiting

Carol Hoffman / email hidden; JavaScript is required

Principal Investigator : Justin Kwan, MD

Bethesda, Maryland 20814
United States

Massachusetts General Hospital | Recruiting

Erin Krahn / email hidden; JavaScript is required

Principal Investigator : Brad Dickerson, MD

Boston, Massachusetts 02114
United States

University of Michigan | Recruiting

Kiren Chaudhry / email hidden; JavaScript is required

Principal Investigator : Sami Barmada, MD

Ann Arbor, Michigan 48109
United States

Mayo Clinic Rochester | Recruiting

Breanna Bruender / email hidden; JavaScript is required

Principal Investigator : Bradley Boeve, MD

Rochester, Minnesota 55905
United States

Washinton University in St. Louis | Recruiting

Tina Nolte / email hidden; JavaScript is required

Principal Investigator : Nupur Ghoshal, MD, PhD

Saint Louis, Missouri 63110
United States

Cleveland Clinic Lou Ruvo Center for Brain Health | Recruiting

Ghanen Concepcion / email hidden; JavaScript is required

Principal Investigator : Dylan Wint, MD

Las Vegas, Nevada 89106
United States

Columbia Unversity | Recruiting

Arlene Mejia / email hidden; JavaScript is required

Principal Investigator : Lawrence Honig, MD

New York, New York 10032
United States

University of North Carolina, Chapel Hill | Recruiting

UNC ALLFTD Team / email hidden; JavaScript is required

Principal Investigator : Andrea Bozoki, MD

Chapel Hill, North Carolina 27514
United States

Case Western Reserve Medical Center | Recruiting

Maria Toth / email hidden; JavaScript is required

Principal Investigator : Brain Appleby, MD

Cleveland, Ohio 44106
United States

University of Pennsylvania | Recruiting

Julia Kwiecinski / email hidden; JavaScript is required

Principal Investigator : David Irwin, MD

Philadelphia, Pennsylvania 19104
United States

Vanderbilt University | Recruiting

Jerica Braswell / email hidden; JavaScript is required

Principal Investigator : Richard R Darby, MD

Nashville, Tennessee 37235
United States

Nantz National Alzheimer Center Houston | Recruiting

Victoria Arbones / email hidden; JavaScript is required

Principal Investigator : Joseph Masdeu, MD, PhD

Houston, Texas 77030
United States

UT San Antonio Health Science Center | Recruiting

Crystal Mendoza / email hidden; JavaScript is required

Principal Investigator : A.Campbell Sullivan, PsyD, ABPP

San Antonio, Texas 78229
United States

University of Washington | Recruiting

Alicia Adams / email hidden; JavaScript is required

Principal Investigator : Kimiko Domoto-Reilly, MD

Seattle, Washington 98195
United States

University of British Columbia | Recruiting

Jessica Luk / email hidden; JavaScript is required

Rachel Freid / 604-827-1050 / email hidden; JavaScript is required

Principal Investigator : Ian Mackenzie, MD, MSc, LMCC, FRCPC

Vancouver, British Columbia
Canada

University of Toronto | Recruiting

Kasey Cortez / email hidden; JavaScript is required

Principal Investigator : Carmela Tartaglia, MD, FRCPC

Toronto, Ontario
Canada