Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL)

Completed

Conditions studied: FTLD, Progressive Supranuclear Palsy (PSP), Frontotemporal Dementia (FTD), Corticobasal Degeneration (CBD), PPA Syndrome, 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 (ALS), Oligosymptomatic PSP (oPSP), Corticobasal Syndrome (CBS)

In brief

Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes: frontotemporal dementia (FTD), primary progressive aphasia (PPA), corticobasal degeneration syndrome (CBS) and progressive supranuclear palsy syndrome (PSPS). The goal of this study is to build a FTLD clinical research consortium to support the development of FTLD therapies for new clinical trials. The consortium, referred to as Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL), will be headquartered at UCSF and will partner with six patient advocacy groups to manage the consortium. Participants will be evaluated at 14 clinical sites throughout North America and a genetics core will genotype all individuals for FTLD associated genes.

Key facts

Study ID

NCT02365922

Run by

University of California, San Francisco

People needed

1489

Starts

2014-09-01

Expected to finish

2020-09-01

Last updated by the study team

2021-05-21

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

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 without a known f-FTLD causing mutation.
• Known presence of an Alzheimer's disease causing mutation in PSEN1, PSEN2 or APP; or neuropathological evidence for Alzheimer's disease as a cause of syndrome (from brain biopsy).
• 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 (such as multiple sclerosis)
• Evidence through history or laboratory testing of B12 deficiency (B12 < 95% of local laboratory's normal value), hypothyroidism (TSH >150% of normal), HIV positive,renal failure (creatinine > 2), liver failure (ALT or AST > two times normal), respiratory failure (requiring oxygen), extra-axial brain tumor (with visible compression of the brain parenchyma), large cerebral infarct that could account for clinical syndrome, large confluent white matter lesions (grades 3 or 4, [107] significant systemic medical illnesses such as deteriorating cardiovascular disease;
• Current medication likely to affect CNS functions in the opinion of the site PI: long acting benzodiazepines such as diazepam (short-acting benzodiazepines are OK), non-SSRI antidepressants (SSRIs or trazodone are OK), no lithium, typical neuroleptics as listed in the Manual of Procedures, narcotics (codeine is OK, but hold 24 hours before neuropsychological testing), anticonvulsants (outside of therapeutic ranges), antihistamines (if taking greater than three times per week; hold 24 hours before neuropsychological testing).
• In the site investigator's opinion, the participant cannot complete sufficient key study procedures, or equivalent assessment of impairment level.
• For groups where MRI scans are planned procedures, any contraindication for MRI scanning, such as pacemaker or other implanted metals.

Where it is running

• University of Alabama — 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
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Harvard University Massachusetts General Hospital — Charlestown, Massachusetts, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Columbia University — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Case Western Reserve University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Washington Harborview Medical Center — Seattle, Washington, United States
• University of British Columbia — Vancouver, British Columbia, Canada
• University of Toronto — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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