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NCT Number: NCT02964637

Diagnosing Frontotemporal Lobar Degeneration

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

Recruiting

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Key information

Conditions

Corticobasal Syndrome Amyotrophic Lateral Sclerosis And/or Frontotemporal Dementia Aphasia Aphasia, Primary Progressive Basal Ganglia Diseases Behavioral Variant Frontotemporal Dementia Brain Diseases Central Nervous System Diseases Communication Disorders Corticobasal Degeneration Cranial Nerve Diseases Dementia Eye Diseases Frontotemporal Dementia Frontotemporal Dementia With Motor Neuron Disease Frontotemporal Lobar Degeneration Language Disorders Mental Disorders Metabolic Diseases Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Ocular Motility Disorders Ophthalmoplegia Paralysis Pathological Conditions, Signs and Symptoms Primary Progressive Nonfluent Aphasia Progressive Nonfluent Aphasia Progressive Supranuclear Palsy Proteostasis Deficiencies Semantic Dementia Signs and Symptoms Speech Disorders Supranuclear Palsy, Progressive TDP-43 Proteinopathies Tauopathies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location status: Recruiting

Location contact

Carmela Tartaglia, MD

CONTACT

[email protected]

416-603-5483

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observational study

Other

Primary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina Salvo, BSc, MD

CONTACT

[email protected]

416-507-6880

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Multimodal Assessment for Predicting Specific Pathological Substrate in Frontotemporal Lobar Degeneration

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Nov 16, 2016
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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