ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)

  • STATUS
    Recruiting
  • End date
    Jul 28, 2024
  • participants needed
    2100
  • sponsor
    Mayo Clinic
Updated on 28 May 2022
dementia
frontotemporal lobar degeneration
primary lateral sclerosis
frontotemporal dementia
amyotrophic lateral sclerosis
progressive supranuclear palsy
dementia, frontotemporal
corticobasal degeneration
Accepts healthy volunteers

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.

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/

Details
Condition 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
Clinical Study IdentifierNCT04363684
SponsorMayo Clinic
Last Modified on28 May 2022

Eligibility

Yes No Not Sure

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)
Participants enrolled in the biofluid arm may be either f-FTLD or s-FTLD. All general
Biofluid-Focused Arm Inclusion Criteria
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
Current medication likely to affect CNS functions in the opinion of the site PI
Evidence through history or laboratory testing of uncorrected B12 deficiency (B12 <
% 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
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
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