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:
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 / 2022
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 CriteriaFamilial 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
Diana Chavez / email hidden; JavaScript is required
Principal Investigator : Mario Mendez, MD
Los Angeles, California
90095
United States
University of California, San Diego | Recruiting
Aishwarya Niraula / 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
Northwestern University | Recruiting
Brittanie Muse / 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
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
Tyler Kolander / 507-284-9295 / 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
Tiffannie Shaw / email hidden; JavaScript is required
Principal Investigator : Aaron Ritter, MD
Las Vegas, Nevada
89106
United States
Columbia Unversity | Recruiting
Masood Manoochehri / email hidden; JavaScript is required
Principal Investigator : Edward Huey, MD
New York, New York
10032
United States
University of North Carolina, Chapel Hill | Recruiting
Brittni Teresi / email hidden; JavaScript is required
Jessica Ferrall / 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
Yvonne Balgenorth / 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
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
Daniela Mora-Fisher / email hidden; JavaScript is required
Behnaz Ghazanfari / email hidden; JavaScript is required
Principal Investigator : Carmela Tartaglia, MD, FRCPC
Toronto, Ontario
Canada