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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 January 2016 |
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Main ID: |
NCT01623284 |
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Date of registration:
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07/06/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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PiB PET Scanning in Speech and Language Based Dementias
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Scientific title:
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PiB PET Scanning in Speech and Language Based Dementias |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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168 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01623284 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Keith A Josephs, M.D. MST, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Over the age of 18
- Has an informant/study partner who will be able to provide independent evaluation of
functioning
- Speaks English as their primary language (including bilingual patients whose primary
language is English)
- Fulfills diagnostic criteria for PPA (Primary Progressive Aphasia) or Progressive
Apraxia of Speech
- Agrees to and is eligible to undergo MRI and PET scanning
- If woman of child bearing age, pt must agree to pregnancy test no more than 48 hours
before the PET scans
Exclusion Criteria:
- Any concurrent illnesses that could account for speech and language deficits, such
as:
- traumatic brain injury, strokes and developmental syndromes
- patients meeting criteria for another neurodegenerative disease (Alzheimer's
Disease, Dementia with Lewy Bodies, behavioral variant frontotemporal dementia,
progressive supranuclear palsy, corticobasal degeneration)
- Women who is pregnant or post-partum and breast-feeding
- Patients for which MRI is contraindicated (metal in head, cardiac pace maker, etc.),
if there is severe claustrophobia, if there are conditions that may confound brain
imaging studies (e.g. structural abnormalities, including subdural hematoma or
intracranial neoplasm), or if they are medically unstable or are on medications that
might affect brain structure or metabolism,(e.g. chemotherapy)
- Patient is mute (secondary to dysarthria only)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Aphasia
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Progressive Aphasia
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Apraxia of Speech
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Non-fluent Aphasia
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Semantic Dementia
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PPA
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Primary Progressive Nonfluent Aphasia
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Primary Progressive Aphasia
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Intervention(s)
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Drug: C-11 PiB
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Drug: F-18 FDG
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Primary Outcome(s)
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Percentage of patients with different speech and language based dementia (SLD) subtypes who have a [N-methyl-11C]2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (PiB) positive positron emission tomography (PET) scan at presentation
[Time Frame: Study entry, approximately day 1 or day 2 of study]
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Secondary Outcome(s)
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Percentage of patients who exhibit apraxia of speech as measured by the Apraxia of Speech Rating Scale at presentation
[Time Frame: Study entry, approximately day 1 or day 2 of study]
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Grey matter loss as shown on magnetic resonance imaging (MRI) at presentation
[Time Frame: Study entry, approximately day 1 or day 2 of study]
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Temporoparietal hypometabolism as shown on [18-F]-fluoro-deoxy-glucose positron emission tomography (FDG-PET) scan at presentation
[Time Frame: Study entry, approximately day 1 or day 2 of study]
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Secondary ID(s)
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09-008772
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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