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Clinical Trials/NCT02964637
NCT02964637
Recruiting
Not Applicable

Multimodal Assessment for Predicting Specific Pathological Substrate in Frontotemporal Lobar Degeneration

University Health Network, Toronto1 site in 1 country100 target enrollmentAugust 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
University Health Network, Toronto
Enrollment
100
Locations
1
Primary Endpoint
Differences between the FTLD groups via PET imaging of the brain
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
December 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carmela Tartaglia

Principal Investigator

University Health Network, Toronto

Eligibility 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.

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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