Neuroimaging in Frontotemporal Dementia
Neuroimaging in Frontotemporal Dementia
Overall Status:
Recruiting
Brief Description:
The goal of this study is to track changes over time among individuals with frontotemporal dementia (FTD) in the brain using imaging and other biomarkers. One hypothesis of this study is that each clinical variant of FTD will be associated with specific brain regions where the greatest changes can be measured over time. The study will compare the utility of different kinds of images.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
45 | 90 | Both | Accepts Healthy Volunteers |
Inclusion Criteria:
- Mini-Mental State Examination (MMSE) score of 18-30; Clinical Dementia Rating of at least 0.5
- Stability of permitted medications for at least 4 weeks prior to screening, in particular, antidepressants lacking significant anticholinergic side effects, estrogen replacement therapy, gingko biloba (permissible but discouraged), cholinesterase inhibitors and memantine
- Geriatric Depression Scale score <6 (15-item version)
- Study partner who has frequent contact with the participant (an average of 10 hours per week or more) and can accompany the participant to all clinic visits
- Adequate seeing and hearing ability to allow neuropsychological testing
- Good general health
- Not pregnant, breastfeeding, or of childbearing potential (women must be 2 years post-menopausal)
- Completed six grades of education or has good work history sufficient to exclude mental retardation
- Fluent in English or Spanish
Exclusion Criteria:
- Significant neurologic disease other than FTD such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities
- Evidence of infection, infarction, or other focal lesions; multiple lacunes
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body
- Longstanding history of major depression, major depression within the past year, bipolar disorder, or schizophrenia
- Longstanding history of alcohol or substance abuse
- Any significant systemic illness or unstable medical condition that could lead to difficulty complying with the protocol
- Participation in clinical studies involving neuropsychological measures and not involving investigational drugs or PET scanning will be allowed, but studies involving neuropsychological testing must be separated from the this study visits by at least 3 months
- Prohibited medications: Warfarin (for those undergoing lumbar puncture); investigational agents prohibited 1 month prior to entry and for the duration of the trial
Detailed Description:
This is a research study about how different types of tests can be used to track the progression of frontotemporal degeneration, a type of dementia due to neurodegenerative disease that causes devastating loss of social and cognitive functions. The goal of this study is to identify the best imaging modalities and the best methods for tracking frontotemporal degeneration over time. The results from this study will be used for clinical drug trials that will use neuroimaging data as an outcome measure. The study will also provide additional information about the relative value of different imaging techniques for diagnosis and the value of imaging versus other blood, urine, and cerebrospinal fluid biomarkers.
Every 6 months, participants will be asked to take tests of memory and thinking skills, answer questions regarding daily functioning and behavior, give blood and urine samples, and have positron emission tomography (PET) and MRI scans of the brain. At the first visit, participants will be asked to have a Pittsburgh Compound-B (PIB) PET scan as well. Participants may also be asked to have spinal taps.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 42.3795409, -71.0646337 | Massachusetts General Hospital | Charleston | Massachusetts | 02129 | Recruiting | Kimiko Domoto-Reilly 617-726-6217 kdomoto-reilly@partners.org |
Geolocation is 44.0557303, -92.5253639 | Mayo Clinic | Rochester | Minnesota | 55905 | Recruiting | Debra Gearhart 507-293-5011 gearhart.debra2@mayo.edu |
Geolocation is 37.7717185, -122.4438929 | University of California, San Francisco | San Francisco | California | 94117 | Marissa Urbano 415-476-0670 murbano@memory.ucsf.edu |
Lead Sponsor:
| Agency |
|---|
National Institute on Aging |
Collaborator Sponsor:
| Agency |
|---|
University of California, San Francisco |
Facility Investigators:
| Name | Affiliation |
|---|---|
Howard Rosen MD | University of California, San Francisco |
Study Contact:
| Name | Phone | |
|---|---|---|
Marissa Urbano | 415-476-0670 |
Locations
Official Title:
Neuroimaging in Frontotemporal Dementia
Study Start Date:
February 2010
Study End Date:
September 2014
Disease Stage:
Early
Middle
Enrollment:
195
Trial References:
Foster, NL, Heidebrink, JL, Clark, CM, et al., FDG-PET improves accuracy in distinguishing frontotemporal dementia and Alzheimer's disease. Brain, 2007. 130(Pt 10): p. 2616-35
Grossman, M, Farmer, J, Leight, S, et al., Cerebrospinal fluid profile in frontotemporal dementia and Alzheimer's disease. Ann Neurol, 2005. 57(5): p. 721-9.
Rosen, HJ, Gorno-Tempini, ML, Goldman, WP, et al., Patterns of brain atrophy in frontotemporal dementia and semantic dementia. Neurology, 2002. 58(2): p. 198-208.
Frisoni, GB, Pizzolato, G, Geroldi, C, et al., Dementia of the Frontal Type: Neuropsychological and [99Tc]-HM-PAO SPET features. J Geriatr Psychiatry Neurol, 1995. 8: p. 42-48.
Rabinovici, GD, Furst, AJ, O'Neil, JP, et al., 11C-PIB PET imaging in Alzheimer disease and frontotemporal lobar degeneration. Neurology, 2007. 68(15): p. 1205-12.
