Corticobasal SyndromeNCT02964637
Diagnosing Frontotemporal Lobar Degeneration
An observational study of Corticobasal Syndrome and Progressive Supranuclear Palsy, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
To establish diagnostic tools to make an accurate clinical and pathological diagnosis of patients with clinical FTLD syndromes Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Corticobasal Syndrome, Progressive Supranuclear Palsy, Behavioral Variant Frontotemporal Dementia
- What is being tested?
- Observational Study
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T 2S8
Carmela Tartaglia, MD, 416-603-5483, carmela.tartaglia@uhn.ca
About this study
Official title: Multimodal Assessment for Predicting Specific Pathological Substrate in Frontotemporal Lobar Degeneration
To establish diagnostic tools to make an accurate clinical and pathological diagnosis of patients with clinical FTLD syndromes
Read the 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.
- Conditions
- Corticobasal Syndrome, Progressive Supranuclear Palsy, Behavioral Variant Frontotemporal Dementia, Semantic Dementia, Progressive Nonfluent Aphasia, Amyotrophic Lateral Sclerosis And/or Frontotemporal Dementia
- Being tested
- Observational Study
- Medical subject headings
- Corticobasal Degeneration, Supranuclear Palsy, Progressive, Frontotemporal Dementia, Primary Progressive Nonfluent Aphasia, Frontotemporal Dementia With Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyOther
| Study group | Role | What they receive |
|---|---|---|
| Progressive supranuclear palsy | Observational Study Receives: Other: Observational Study | |
| Corticobasal syndrome | Observational Study Receives: Other: Observational Study | |
| Behavoral variant FTD | Observational Study Receives: Other: Observational Study | |
| Semantic variant PPA | Observational Study Receives: Other: Observational Study | |
| Non-fluent variant PPA | Observational Study Receives: Other: Observational Study | |
| FTD-motor neuron disease | Observational Study Receives: Other: Observational Study | |
| Healthy controls | Observational Study Receives: Other: Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural and Functional Diffferences between the FTLD groups via MRI of the brain
Differences in brain volumes and resting state functional connectivity
Measured: One time visit through study completion of 5 years
Differences between the FTLD groups via PET imaging of the brain
Differences in ligand uptake
Measured: One time visit through study completion of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startAug 2015
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corticobasal SyndromeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmela Tartaglia, University Health Network, Toronto
- Investigators
- Maria C Tartaglia, M.D., Principal investigator, Toronto Western Hospital, UHN; Tanz CRND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964637
- Sponsor's protocol ID
- 14-8398-A
- Status last verified
- Apr 2019
- First submitted
- 23 Sep 2016
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Assessment for Predicting Specific Pathological Substrate in Frontotemporal Lobar Degeneration
- ClinicalTrials.gov ID
- NCT02964637
- Acronym / sponsor ID
- 14-8398-A
- Conditions
- Corticobasal Syndrome, Progressive Supranuclear Palsy, Behavioral Variant Frontotemporal Dementia, Semantic Dementia, Progressive Nonfluent Aphasia, Amyotrophic Lateral Sclerosis And/or Frontotemporal Dementia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Progressive supranuclear palsy | – | Other: Observational StudyObservational Study |
| Corticobasal syndrome | – | Other: Observational StudyObservational Study |
| Behavoral variant FTD | – | Other: Observational StudyObservational Study |
| Semantic variant PPA | – | Other: Observational StudyObservational Study |
| Non-fluent variant PPA | – | Other: Observational StudyObservational Study |
| FTD-motor neuron disease | – | Other: Observational StudyObservational Study |
| Healthy controls | – | Other: Observational StudyObservational Study |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Study | Other | Behavoral variant FTD, Corticobasal syndrome, FTD-motor neuron disease, Healthy controls, Non-fluent variant PPA, Progressive supranuclear palsy, Semantic variant PPA |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria C Tartaglia, M.D. principal investigator
Toronto Western Hospital, UHN; Tanz CRND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corticobasal Syndrome and Progressive Supranuclear Palsy, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Salvo, BSc, MD (416-507-6880, cristina.salvo@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural and Functional Diffferences between the FTLD groups via MRI of the brain (time frame: One time visit through study completion of 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.