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The Neural Basis for Frontotemporal Degeneration

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ClinicalTrials.gov Identifier: NCT03452956
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
This is an observational study that aims to better understand the genetic causes of frontotemporal degeneration (FTD), Multiple Systems Atrophy (MSA), and Progressive Supranuclear Palsy (PSP). It is hoped the information gathered in this study will help lead to better diagnostics and future treatments.

Condition or disease Intervention/treatment
Frontotemporal Degeneration Progressive Supranuclear Palsy Multiple System Atrophy Other: None-Observation Only

Detailed Description:
Comparative and longitudinal studies reveal clinical differences between subgroups of patients with frontotemporal dementia (FTD), including Progressive Non-fluent Aphasia (PNFA), Semantic Dementia (SD), patients with a disorder of social comportment and personality (SOC), and non-aphasic patients with executive dysfunction (EXEC). MRI studies of cortical atrophy and fMRI studies show correlated neural defects in FTD subgroups. The investigators will obtain converging evidence from multiple sources to test hypotheses about the neural basis for cognitive functions such as semantic memory, grammatical processing, and social functioning in these FTD subgroups, while improving clinical care for these patients. Recent studies have linked progressive supra nuclear palsy (PSP) and multiple systems atrophy (MSA) to FTD. The investigators will obtain comparable neuropsychological and biomarker data in order to compare these patient groups.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Neural Basis for Frontotemporal Degeneration
Actual Study Start Date : July 1, 2003
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2026


Group/Cohort Intervention/treatment
FTD Cohort
No intervention-observation only
Other: None-Observation Only
No intervention-this is an observational study




Primary Outcome Measures :
  1. Progression [ Time Frame: This is a natural history study - participants are followed from date of enrollment until death, withdrawl, or funding is no longer available, or until 984 months have passed ]
    Changes over time in MRI and cognitive testing data.


Secondary Outcome Measures :
  1. Impaired semantic memory in Semantic Dementia (SD). [ Time Frame: This is a natural history study - participants are followed from date of enrollment until death, withdrawl, or funding is no longer available, or until 984 months have passed ]
    The impact of cortical atrophy on language processing.


Other Outcome Measures:
  1. Effortful speech in Progressive Nonfluent Aphasia (PNFA) [ Time Frame: This is a natural history study - participants are followed from date of enrollment until death, withdrawl, or funding is no longer available, or until 984 months have passed ]
    Speech samples related to cortical atrophy seen on MRI and fMRI studies of verb past tense inflection.

  2. Social disinhibition and rule violation in FTD [ Time Frame: This is a natural history study - participants are followed from date of enrollment until death, withdrawl, or funding is no longer available, or until 984 months have passed ]
    Relationship of cognitive testing and MRI data and changes over time.


Biospecimen Retention:   Samples With DNA
Cerebral Spinal Fluid (CSF) and blood samples will both be taken and stored for DNA and RNA extraction and analysis and University of Pennsylvania Center for Neurodegenertive Research Center (CNDR).


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All individuals with a diagnosis of FTD, PSP, or MSA, previously identified by the PI and sub-investigators through other FTD studies (protocol number 702681) and through the PI's extensive FTD clinical practice at the University of Pennsylvania and at Pennsylvania Hospital's Department of Neurology, will be recruited through letters, brochures, and study flyers.
Criteria

Inclusion Criteria:

  • Individuals who have been diagnosed with FTD, PSP, and MSA

Exclusion Criteria:

  • Individuals under 18 years of age
  • People with pacemakers or certain metallic implants
  • pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452956


Contacts
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Contact: Katie Pizziketti, BA 215-349-5873 katie.pizziketti@uphs.upenn.edu
Contact: Courtney Igne, MS 215-662-3596 cigne@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Katie Pizziketti, BA    215-349-5873    katie.pizziketti@uphs.upenn.edu   
Contact: Courtney Igne, MS    215-662-3596    cigne@pennmedicine.upenn.edu   
Principal Investigator: Murray Grossman, PhD, MD         
Sub-Investigator: David Irwin, PhD, MD         
Sponsors and Collaborators
University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03452956     History of Changes
Other Study ID Numbers: 298201
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The University of Pennsylvania is a participant in the National Alzheimer's Coordinating Center 's FTLD-NACC initiative to create a national database of data specific to FTD spectrum diseases.The FTLD NACC initiative will enable research centers focusing on FTD spectrum diseases to gather standardized data on their FTLD patients, all of which will be combined into a single database and made freely available to researchers around the world.

The FTLD-NACC collects data standardly obtained in this study, including neurocognitive assessments, MRI imaging data, and biomarkers collected through lumbar puncture and blood draw.The FTLD-NACC is designed to facilitate collaborative research and will allow researchers to maximize the use of clinical information and biological material available on frontotemporal degenerative spectrum diseases. Subjects will be able to choose whether or not their research data is shared with the FTD-NACC.

Time Frame: As this is an ongoing, longitudinal study, IPD will be available through the duration of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Brain Diseases
Supranuclear Palsy, Progressive
Atrophy
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms