Diagnosing Frontotemporal Lobar Degeneration

NCT02964637 | Recruiting

• 1 other identifier: 14-8398-A
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Corticobasal Syndrome; Progressive Supranuclear Palsy; Behavioral Variant Frontotemporal Dementia; Semantic Dementia; Progressive Nonfluent Aphasia; Amyotrophic Lateral Sclerosis And/or Frontotemporal Dementia

Outcome Measures

Primary Outcomes (2)

• Structural and Functional Diffferences between the FTLD groups via MRI of the brain

  Differences in brain volumes and resting state functional connectivity

  One time visit through study completion of 5 years

• Differences between the FTLD groups via PET imaging of the brain

  Differences in ligand uptake

  One time visit through study completion of 5 years

Study Arms (7)

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

Interventions

Observational Study OTHER

Behavoral variant FTD; Corticobasal syndrome; FTD-motor neuron disease; Healthy controls; Non-fluent variant PPA; Progressive supranuclear palsy; Semantic variant PPA

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.
• Control subjects must have a normal neurological exam, a CDR sum of boxes = 0, and MMSE score equal to or greater than 28

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

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.

MeSH Terms

Conditions

Corticobasal Degeneration; Supranuclear Palsy, Progressive; Frontotemporal Dementia; Primary Progressive Nonfluent Aphasia; Frontotemporal Dementia With Motor Neuron Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

Tauopathies; Neurodegenerative Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Frontotemporal Lobar Degeneration; Dementia; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders; Aphasia, Primary Progressive; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Maria C Tartaglia, M.D.

  Toronto Western Hospital, UHN; Tanz CRND

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Salvo, BSc, MD

CONTACT

416-507-6880; cristina.salvo@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: November 16, 2016
• Study Start: August 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)