Vascular Dementia Clinical Trial
Official title:
GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title
NCT number | NCT00209456 |
Other study ID # | PDT301 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | September 13, 2005 |
Last updated | May 15, 2007 |
Start date | November 2003 |
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.
Status | Completed |
Enrollment | 326 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 55 Years to 90 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Germany | Amersham Buchler GmbH Co. KG | Ismaning |
Lead Sponsor | Collaborator |
---|---|
GE Healthcare |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity and specificity of DaTSCAN SPECT scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB dementia subjects. | |||
Secondary | Accuracy, positive predictive value and negative predictive value of DaTSCAN SPECT | |||
Secondary | Semi-quantitative analysis of the striatal uptake ratios of DaTSCAN SPECT images. | |||
Secondary | Impact of DaTSCAN SPECT analysis on the confidence of diagnosis. | |||
Secondary | Findings in relation to probable, possible and no-DLB. | |||
Secondary | Efficacy analysis at 12-month follow-up period. | |||
Secondary | Safety profile |
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