Posterior Cortical Atrophy (PCA) Clinical Trial
Official title:
Amyloid-related Imaging Abnormalities (Microbleeds) in Atypical AD
Verified date | December 2015 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The study is designed to assess the demographic, clinical and imaging associations with the presence of microbleeds in atypical Alzheimer's disease. The primary hypothesis is that cognitive and functional performance will be poorer in atypical Alzheimer's subjects with microbleeds compared to those without microbleeds.
Status | Completed |
Enrollment | 27 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - over the age of 21 - will have an informant/study partner who will be able to provide independent evaluation of functioning - must fulfill clinical diagnostic criteria for atypical AD, and hence should either have a chief complaint of difficulty with language and fulfill criteria for logopenic variant of primary progressive aphasia, or present with visuospatial/perceptual deficits and fulfill criteria for posterior cortical atrophy - speaks English as their primary language (including bilingual patients whose primary language is English) - agrees to and is eligible to undergo MRI and PET scanning - if woman of child bearing age, must agree to pregnancy test no more than 48 hours before the PET scans Exclusion Criteria: - subjects with concurrent illnesses that could account for the presenting syndrome, such as traumatic brain injury, strokes or developmental syndromes - subjects meeting criteria for another neurodegenerative disease, particularly typical Alzheimer's dementia - women that are pregnant or post-partum and breast-feeding - subjects will also be excluded if MRI is contraindicated (metal in head, cardiac pace maker, e.t.c.), if there is severe claustrophobia, and if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma or intracranial neoplasm) - subjects will also be excluded if they do not have an informant, do not consent to research or do not complete all components of the study (neurological exam, neuropsychometric tests, MRI, PiB PET) |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects with and without microbleeds | up to day 2 of study | No | |
Secondary | Percentage of white matter hyperintensity burden on MRI and ratio of amyloid burden on PiB PET scan | Study entry, approximately day 1 or day 2 of study | No | |
Secondary | Number of microbleeds per subject | Study entry, approximately day 1 or day 2 of study | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02289118 -
Tau Imaging in Young Onset Dementia
|
||
Recruiting |
NCT02740634 -
Molecular and Structural Imaging in Alzheimer's Disease: A Longitudinal Study
|
N/A |