Brief Title
ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)
Official Title
ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)
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 Type
Observational
Primary Outcome
Change in Brain Volumes
Secondary Outcome
Plasma Neurofilament Light Chain Analysis
Condition
Frontotemporal Lobar Degeneration (FTLD)
Study Arms / Comparison Groups
Longitudinal Arm
Description: Annual clinic visits throughout the length of the study.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
2100
Start Date
March 1, 2020
Completion Date
July 2024
Primary Completion Date
July 2024
Eligibility Criteria
Longitudinal Arm 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)
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Bradley Boeve, MD, 507-293-9577, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT04363684
Organization ID
19-004543
Secondary IDs
U19AG063911
Responsible Party
Principal Investigator
Study Sponsor
Mayo Clinic
Collaborators
University of California, San Francisco
Study Sponsor
Bradley Boeve, MD, Principal Investigator, Mayo Clinic
Verification Date
May 2022