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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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12 December 2020 |
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Main ID: |
NCT02372773 |
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Date of registration:
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20/02/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Longitudinal Evaluation of Familial Frontotemporal Dementia Subjects
LEFFTDS |
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Scientific title:
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Longitudinal Evaluation of Familial Frontotemporal Dementia Subjects |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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398 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02372773 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Bradley Boeve, MD |
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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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Name:
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Howard Rosen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Must be a member of family with a known mutation in one of the three major FTLD
related genes: MAPT, PGRN, or C9ORF72.
2. At least 18 years of age.
3. The predominant phenotype in the kindred must be cognitive/behavioral (ie, kindreds in
whom parkinsonism or ALS is the predominant clinical phenotype among affected
relatives may be excluded)
4. Have a reliable informant who personally speaks with or sees that subject at least
weekly.
5. Subject is sufficiently fluent in English to complete all measures
6. Subject must be willing and able to consent to the protocol and undergo yearly
evaluations over 3 years.
7. Subject must be willing and able to undergo neuropsychological testing (at least at
baseline visit).
8. Subject must have no contraindication to MRI imaging.
Exclusion Criteria
1. Known presence of a structural brain lesion (e.g. tumor, cortical infarct).
2. Presence of another neurologic disorder which could impact findings (eg, multiple
sclerosis).
3. Subject is unwilling to return for follow-up yearly, undergo neuropsychological
testing and MR imaging.
4. Subject has no reliable informant.
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Familial Frontotemporal Dementia
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Primary Outcome(s)
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Rate of decline in traditional measures of clinical (neuropsychological and behavioral composites) function and cortical volume on structural MRI in the symptomatic phase of familial FTD
[Time Frame: 5 years]
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Secondary Outcome(s)
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Genetic and biofluid factors that modify rates of clinical and neuroimaging decline in the asymptomatic and symptomatic phases of familial FTD.
[Time Frame: 5 years]
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Rate of decline in traditional measures of clinical (neuropsychological and behavioral composites) function and cortical volume on structural MRI in the asymptomatic phase of familial FTD
[Time Frame: 5 years]
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Value of novel imaging and clinical measures for characterizing asymptomatic familial FTD subjects, and factors predicting clinical rates of progression in each group.
[Time Frame: 5 years]
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Secondary ID(s)
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14-007532
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U01AG045390
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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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