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A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9ORF72 Mutations Causative of Frontotemporal Dementia
Rochester, Minn.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AL001 in participants with a frontotemporal dementia.
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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).
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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).
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ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) (ALLFTD)
Rochester, Minn.,
Jacksonville, Fla.
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.
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Longitudinal Imaging Biomarkers of Disease Progression in DLB
Rochester, Minn.,
Jacksonville, Fla.
To determine the paths of change in imaging biomarkers of DLB and their associations with rate of cognitive and functional decline.
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Closed for Enrollment
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A Double-Blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects with Progressive Supranuclear Palsy
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this study is to evaluate the safety, tolerability and drug/body interactions of C2N-8E12 in patients with progressive supranuclear palsy.
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A Double-Blind, Placebo-Controlled 16-Week Study of the Cognitive Effects of Oral p38 Alpha Kinase Inhibitor Neflamapimod in Dementia With Lewy Bodies (DLB) (AscenD-LB)
Rochester, Minn.
The purpose of this study is to evaluate the effect of neflamapimod on cognitive function as assessed in a study-specific Cogstate Neuropsychological Test Battery (NTB).
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A Phase 2, Double-Blind, Randomized, Placebo-Controlled Cross-Over Study of Nelotanserin versus Placebo in Lewy Body Dementia Subjects Experiencing Visual Hallucinations
Rochester, Minn.
The purpose of this study is to evaluate the safety and effectiveness of Nelotanserin for the treatment of visual hallucinations in patients with Lewy body dementia.
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A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
Jacksonville, Fla.,
Rochester, Minn.
This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.
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A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects With Prodromal to Moderate Frontotemporal Dementia With Granulin Mutation
Rochester, Minn.
The purposes of this study are to investigate the safety, tolerability, and pharmacodynamics of FRM-0334 in subjects with prodromal to moderate frontotemporal dementia with granulin mutation.
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A Study to Model Rates of Change on Neuropsychological Test Measures in Subjects Diagnosed With Behavioral Variant Frontotemporal Dementia and Healthy Subjects
Rochester, Minn.
The objectives of the study are to; (1) estimate the change in disease -related cognitive decline over 1 year on a battery of cognitive tests administered to participants with early-stage symptomatic Behavioral Variant Frontotemporal Dementia (bvFTD) phenotypic variant; (2) identify the cognitive test or brief battery of cognitive tests which are the most sensitive to detect bvFTD progression; (3) determine the optimal schedule of administration of cognitive tests to detect bvFTD progression; (4) evaluate the relationship between cognitive tests and measures of behavior, function, caregiver's burden, quality of life (QOL); and (5) obtain blood samples for genetic and exploratory biomarkers correlations.
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An Open Label, Single-Center Pilot Study of Armodafinil in Patients with Dementia with Lewy Bodies
Rochester, Minn.
The purpose of this study is to examine the effects of the medication Armodafinil in patients who have dementia with Lewy bodies which is associated with memory loss and other thinking problems, excessive daytime sleepiness, hallucinations, delusions, apathy, and reduced quality of life.
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An Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior Disorder
Rochester, Minn.
This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with Lewy body dementia (LBD).
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DaTSCAN Imaging in Aging and Neurodegenerative Disease
Rochester, Minn.,
Jacksonville, Fla.
The investigators propose using DaTscan in patients with mild cognitive impairment (MCI), Parkinson's disease (PD), dementia with Lewy bodies (DLB), Alzheimer's disease (AD), and other neurodegenerative syndromes and disorders, to test several hypotheses - some confirmatory, and some novel. Such use will provide new data on the potential clinical and research utility of DaTscan in neurodegenerative diseases. The findings on DaTscan will be correlated with clinical diagnoses and other multimodal imaging studies (e.g., MRI, MRS, FDG-PET, and amyloid-PET) to enhance our understanding of neurodegenerative diseases.
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Integrated Neurocognitive and Sleep-Behavior Profiler for the Endophenotypic Classification of Dementia Subtypes (INSPECDS) (INSPECDS)
Rochester, Minn.
This study is being done to identify and characterize neurophysiological biomarkers for progression of neurodegenerative disease from physiological and subjective measurements.
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Longitudinal Evaluation of Familial Frontotemporal Dementia Subjects (LEFFTDS)
Rochester, Minn.,
Jacksonville, Fla.
This study is being done to learn more about normal thinking and behavior, mild thinking and behavior problems, Frontotemporal Dementia and other forms of dementia in families in which one or more relatives have a mutation associated with Frontotemporal Dementia.
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North American Prodromal Synucleinopathy (NAPS) Consortium (NAPS)
Rochester, Minn.
The purpose of this study is to establish a registry of RBD patients, develop quantitative biological and functional measures of synucleinopathy burden, and establish a formal process to evaluate candidate neuroprotective agents.
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Remote Blood Biomarker Monitoring in Frontotemporal Lobar Degeneration: Neurofilament Surveillance Project (NSP) (NSP)
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to collect and analyze blood specimens from individuals carrying known familial frontotemporal lobar degeneration (f-FTLD) mutations compared to a control group of individuals without known f-FTLD mutations.
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