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Diagnosing Frontotemporal Lobar Degeneration

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ClinicalTrials.gov Identifier: NCT02964637
Recruitment Status : Recruiting
First Posted : November 16, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Carmela Tartaglia, University Health Network, Toronto

Brief Summary:
To establish diagnostic tools to make an accurate clinical and pathological diagnosis of patients with clinical FTLD syndromes

Condition or disease Intervention/treatment
Corticobasal Syndrome Progressive Supranuclear Palsy Behavioral Variant Frontotemporal Dementia Semantic Dementia Progressive Nonfluent Aphasia Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia Other: Observational Study

Detailed Description:
The goal of this study is to determine the best diagnostic test for diagnosing frontotemporal lobar degeneration. To accomplish this, the current study will evaluate different tests: brain imaging, skin biopsy, body fluid samples (blood and cerebrospinal fluid), thinking abilities, everyday functioning, and brain autopsy. The study team hopes that this information can be used to guide diagnosis and further understanding of mechanism of disease in Frontotemporal Lobar Degeneration and possibly treatment in the future.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Multimodal Assessment For Predicting Specific Pathological Substrate in Frontotemporal Lobar Degeneration
Study Start Date : August 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Group/Cohort Intervention/treatment
Progressive supranuclear palsy
Observational Study
Other: Observational Study
Corticobasal syndrome
Observational Study
Other: Observational Study
Behavoral variant FTD
Observational Study
Other: Observational Study
Semantic variant PPA
Observational Study
Other: Observational Study
Non-fluent variant PPA
Observational Study
Other: Observational Study
FTD-motor neuron disease
Observational Study
Other: Observational Study
Healthy controls
Observational Study
Other: Observational Study



Primary Outcome Measures :
  1. Structural and Functional Diffferences between the FTLD groups via MRI of the brain [ Time Frame: One time visit through study completion of 5 years ]
    Differences in brain volumes and resting state functional connectivity

  2. Differences between the FTLD groups via PET imaging of the brain [ Time Frame: One time visit through study completion of 5 years ]
    Differences in ligand uptake


Biospecimen Retention:   Samples With DNA
Blood for biomarkers will be collected from participants for genetic testing. In addition, cerebrospinal fluid (CSF) will be collected to measure levels of different proteins, such as tau.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with a diagnosis of progressive supranuclear palsy (PSP), corticobasal syndrome (CBS), semantic variant primary progressive aphasia (sv-PPA), non-fluent variant PPA (nfv-PPA), behavioral variant frontotemporal dementia (bvFTD) or FTD-motor neuron disease (FTD-MND).
Criteria

Inclusion Criteria:

  • Participant must have a reliable study partner who can provide an independent evaluation of functioning.
  • Able to read, understand and speak English for neuropsychological testing.
  • All subjects must meet one of these diagnostic criteria (A) probable behavioral variant FTD, (B) MRI-supported non-fluent variant PPA; (C) MRI-supported semantic variant PPA and [18F]T807 negative (D) probable CBS: using current criteria for CBS(27); (E) PSP: inclusion criteria for PSP are based upon the National Institute of Neurological Disorders and Stroke Society of Progressive Supranuclear Palsy (NINDS-SPSP) (F) FTD-MND
  • Control subjects must have a normal neurological exam, a CDR sum of boxes = 0, and MMSE score equal to or greater than 28

Exclusion Criteria:

  • Patients with clinical, imaging or CSF A beta/ tau profile consistent with AD
  • History of traumatic brain injury, brain tumors, stroke or other neurological or psychiatric disorders that can explain symptoms will be excluded.
  • Premenopausal women will be asked to consent to a pregnancy test prior to each scan as pregnant women will be excluded from study because of potential harm to fetus from PET study.
  • Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body.

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): NCT02964637


Contacts
Contact: Namita Multani, MSc 416-507-6880 namita.multani@mail.utoronto.ca

Locations
Canada, Ontario
Toronto Western Hospital, University Health Network Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Carmela Tartaglia, MD    416-603-5483    carmela.tartaglia@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Maria C Tartaglia, M.D. Toronto Western Hospital, UHN; Tanz CRND

Responsible Party: Carmela Tartaglia, Principal Investigator, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02964637     History of Changes
Other Study ID Numbers: 14-8398-A
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Dementia
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Aphasia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Supranuclear Palsy, Progressive
Frontotemporal Lobar Degeneration
Aphasia, Broca
Primary Progressive Nonfluent Aphasia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Neuromuscular Diseases
Spinal Cord Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Basal Ganglia Diseases
Movement Disorders