Diagnosing Frontotemporal Lobar Degeneration

Progressive Supranuclear Palsy Clinical Trial

Official title:

Multimodal Assessment For Predicting Specific Pathological Substrate in Frontotemporal Lobar Degeneration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02964637
• Other study ID #: 14-8398-A
• Status: Recruiting
• Start date: August 2015
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: University Health Network, Toronto
• Contact: Cristina Salvo, BSc, MD
• Phone: 416-507-6880
• Email: cristina.salvo[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia
• Aphasia
• Aphasia, Broca
• Aphasia, Primary Progressive
• Behavioral Variant Frontotemporal Dementia
• Corticobasal Syndrome
• Dementia
• Frontotemporal Dementia
• Frontotemporal Lobar Degeneration
• Motor Neuron Disease
• Pick Disease of the Brain
• Primary Progressive Nonfluent Aphasia
• Progressive Nonfluent Aphasia
• Progressive Supranuclear Palsy
• Semantic Dementia
• Supranuclear Palsy, Progressive

Intervention

Other:
• Observational Study

Locations

Country	Name	City	State
Canada	Toronto Western Hospital, University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Differences between the FTLD groups via PET imaging of the brain	Differences in ligand uptake	One time visit through study completion of 5 years