Familial Frontotemporal Dementia Clinical Trial
— LEFFTDSOfficial title:
Longitudinal Evaluation of Familial Frontotemporal Dementia Subjects
| Verified date | July 2020 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study is being done to learn more about normal thinking and behavior, mild thinking and behavior problems, Frontotemporal Dementia and other forms of dementia in families in which one or more relatives have a mutation associated with Frontotemporal Dementia.
| Status | Completed |
| Enrollment | 398 |
| Est. completion date | June 30, 2020 |
| Est. primary completion date | June 30, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of British Columbia | Vancouver | British Columbia |
| United States | Harvard University | Charlestown | Massachusetts |
| United States | Mayo Clinic Florida | Jacksonville | Florida |
| United States | Columbia University | New York | New York |
| United States | Univerisity of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Washington University | Saint Louis | Missouri |
| United States | University of California, San Francisco, Memory and Aging Center, Department of Neurology | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic | National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA) |
United States, Canada,
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* Note: There are 24 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | neuropsychological, clinical/behavioral, neuroimaging measures | 5 years | |
| Secondary | 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 | neuropsychological, clinical/behavioral, neuroimaging measures | 5 years | |
| Secondary | Value of novel imaging and clinical measures for characterizing asymptomatic familial FTD subjects, and factors predicting clinical rates of progression in each group. | neuropsychological, clinical/behavioral, neuroimaging measures | 5 years | |
| Secondary | Genetic and biofluid factors that modify rates of clinical and neuroimaging decline in the asymptomatic and symptomatic phases of familial FTD. | genetic and biolfuid factors | 5 years |