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Clinical Studies


  • A Phase 2a Study of TPN-101 in Patients with C9ORF72 ALS/FTD (Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia) (TPN-101) Rochester, Minn.

    The primary objective of this study is to assess the safety and tolerability of TPN-101 in patients with C9ORF72 amyotrophic lateral sclerosis (ALS)/frontotemporal dementia (FTD).



  • A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Rochester, Minn.

    The primary purpose of this study is to evaluate the efficacy of AL001 compared with placebo in carriers of progranulin gene (GRN) mutations causative of frontotemporal dementia (FTD) as measured by the Clinical Dementia Rating Dementia Staging Instrument PLUS National Alzheimer’s Disease Coordinating Center frontotemporal lobar degeneration Behavior & Language Domains Sum of Boxes (CDR® plus NACC FTLD-SB).

  • ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) (ALLFTD) Jacksonville, Fla., Rochester, Minn.

    The purpose of this study is 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.  FTLD is a neurodegenerative disorder of the nervous system which there are no approved treatments or cures.

    The study has two arms: a “longitudinal arm” involving a comprehensive assessment of clinical, functional, imaging, and biofluid data collection, and a “biofluid-focused arm” involving limited clinical data to accompany biospecimen collection.

  • Longitudinal Imaging Biomarkers of Prodromal and Overt DLB Rochester, Minn., Jacksonville, Fla.

    Longitudinal Imaging Biomarkers of Disease Progression in Prodromal and Overt DLB

  • North American Prodromal Synucleinopathy Consortium for RBD, Stage 2 (NAPS2) (NAPS2) Rochester, Minn.

    Most individuals with rapid eye movement (REM) sleep behavior disorder (RBD) develop additional
    neurological symptoms and are subsequently diagnosed with overt synucleinopathies, including dementia with
    Lewy bodies (DLB), Parkinson disease (PD), and multiple system atrophy (MSA), indicating that RBD
    represents a prodromal stage of synucleinopathy. RBD therefore offers a window of opportunity to intervene
    with neuroprotective treatments at the earliest stages of disease when treatment is most likely to be effective.
    Recognizing the importance of early intervention, key federal agencies focused on neurodegenerative disease
    have proposed high priority recommendations for prodromal aspects of synucleinopathies, including
    specifically RBD, to prepare for clinical trials. The North American Prodromal Synucleinopathy (NAPS)
    Consortium began in 2018 to plan for neuroprotective clinical trials in RBD. The NAPS Consortium, currently at
    10 sites, has thus far enrolled 215 participants with polysomnogram-confirmed RBD, and has successfully
    performed comprehensive and standardized assessments and biofluids collection. The North American
    Prodromal Synculeinopathy Consortium for RBD, Stage 2 (NAPS2) program represents an integrated
    expansion of NAPS to support a longitudinal, prospective study of RBD, to address key gaps currently
    prohibiting neuroprotective clinical trials in RBD. NAPS2 will establish enhanced infrastructure to support longterm
    research in prodromal synucleinopathies.

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