ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)

Recruiting

• 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 Sclerosis; Oligosymptomatic PSP (oPSP); C9orf72

• Registration Number: NCT04363684
• Lead Sponsor: Mayo Clinic

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.

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/

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-27
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-11
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2100

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in NIH Examiner Executive Composite Score	Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year	Evaluate change in NIH Examiner Executive Composite Score in asymptomatic f-FTLD.
Change in Multidomain Impairment Rating (MIR) Scale	Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year	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.
Change in Brain Volumes	Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year	Compare rates of change in whole brain and regional volumes between asymptomatic f-FTLD and symptomatic f- and s-FTLD, measured using MRI.

Secondary Outcome Measures

Name	Time	Method
Plasma Neurofilament Light Chain Analysis	5 years	Annual blood samples will be collected to detect changes in plasma neurofilament light chain concentrations

Trial Locations

Locations (27)

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

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