Health TrialsbyHealthPanel

ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)

ConditionsFrontotemporal 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
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Progressive Supranuclear Palsy (PSP)

Semantic variant Primary Progressive Aphasia (svPPA)

Disqualifiers

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.

Trial population

Participants will have a referring diagnosis of an FTLD clinical syndrome or will be a member of a family with a strong family history of an FTLD syndrome.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,100 Participants
are grouped into 2 trial groups
Group A: Longitudinal Arm
Group B: Biofluid-Focused Arm

Trial outcomes

Primary outcomes

1

Change in Brain Volumes

Compare rates of change in whole brain and regional volumes between asymptomatic f-FTLD and symptomatic f- and s-FTLD, measured using MRI.

Time frame
Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
2

Change in neuropsychological battery

Evaluate change in performance on a neuropsychological battery in asymptomatic f-FTLD as well as symptomatic f-FTLD and s-FTLD.

Time frame
Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
3

Change in Multidomain Impairment Rating (MIR) Scale

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.

Time frame
Baseline, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year

Secondary outcomes

1

Plasma Neurofilament Light Chain Analysis

Annual blood samples will be collected to detect changes in plasma neurofilament light chain concentrations

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

University of California, San Francisco

Collaborator

National Institute on Aging (NIA)

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov
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