Alzheimer's, Lewy Body Dementia, Non-DLB Dementia, Vascular Dementia
Conditions
Keywords
Lewy Body Dementia, non-DLB dementia, Dopamine Transporter, Striatal Uptake
Brief summary
The study is designed to determine the diagnostic efficacy of the visual assessment of SPECT scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB dementia subjects determined by the clinical diagnosis of an independent expert consensus panel used as the standard of truth.
Detailed description
GEHC had decided notto provide this detail
Interventions
DRUGDatSCAN
Sponsors
GE Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must be adults between 55 to 90 years of age with an established diagnosis for dementia in accordance with DSM-IV criteria and have to fulfil at least one of the following: The ICC criteria for probable and possible DLB, the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer Disease and Related Disorders Association (NINCDS-ADRDA) for Alzheimer's Disease (AD), or the National Institute of Neurological and Communicative Disorders and Association Internationale Pour la Recherche et l'Enseignement en Neurosciences (NINCS-AIREN) for Vascular Dementia (VaD).
Exclusion criteria
* Subjects are not eligible if they have a Mini Mental State Examination (MMSE) score of \<10 and use medication known or suspected to interact with the striatal uptake DaTSCAN to the dopamine transporter. * Furthermore subjects are not eligible if they were diagnosed with idiopathic Parkinson's Disease (PD), with persistent severe depression, normal pressure hydrocephalus, multiple system atrophy, cortico-basal degeneration or Huntington's Chorea Disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of DaTSCAN SPECT scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB dementia subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Semi-quantitative analysis of the striatal uptake ratios of DaTSCAN SPECT images. | — |
| Impact of DaTSCAN SPECT analysis on the confidence of diagnosis. | — |
| Accuracy, positive predictive value and negative predictive value of DaTSCAN SPECT | — |
| Efficacy analysis at 12-month follow-up period. | — |
| Safety profile | — |
| Findings in relation to probable, possible and no-DLB. | — |
Countries
Germany
Outcome results
None listed