NCT04363684Recruiting
ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2100 (estimated)
- First submitted
- 2 Apr 2020
- Start date
- 1 Mar 2020
- Primary completion date
- 31 Aug 2030
- Lead sponsor
- Mayo Clinic
- NCT number
- NCT04363684
What you commit to
- Study type: Observational
- Planned participants: 2100
- From 1 Mar 2020 to the primary completion date, 31 Aug 2030
- 26 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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.
Other
- Known presence of a structural brain lesion (e.g. tumor, cortical infarct) that could reasonably explain symptoms in a symptomatic participant.
- 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.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| University of British Columbia Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| NIH Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
| University of Alabama Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of North Carolina, Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Case Western Reserve Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| University of Colorado Denver Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Nantz National Alzheimer Center Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Mayo Clinic Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Vanderbilt University Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| UT San Antonio Health Science Center Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| University of California San Diego Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Washinton University in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.