DaTSCAN GE-001-013
Research type
Research Study
Full title
A Multicentre, Randomised, Open-Label, Comparative Phase 4 Trial To Assess Changes in Dementia Diagnostic Category and Diagnostic Confidence After DaTSCAN Imaging in Subjects with an Uncertain Diagnosis of Dementia with Lewy Bodies (Possible DLB)
IRAS ID
60574
Contact name
Zuzana Walker
Contact email
Sponsor organisation
GE Healthcare
Eudract number
2010-021474-11
ISRCTN Number
ISRCTN
Clinicaltrials.gov Identifier
NCT
Research summary
The hypothesis to test is that a higher proportion of participants who undergo SPECT imaging of the head with DaTSCAN will have a change in a diagnostic category relating to dementia with Lewy bodies (DLB) e.g., a change from possible (uncertain) DLB to probable (certain) DLB or non-DLB dementia, compared to a control group of participants who do not undergo DaTSCAN imaging.
Results from several studies have demonstrated that the clinical diagnosis of DLB has a high specificity but low sensitivity and a high diagnostic accuracy after DaTSCAN imaging.
The course and the clinical management of DLB differ in some important aspects from other dementias such as Alzheimer’s disease. There is evidence that disease evolves more rapidly, requiring special medical care; resulting in earlier long-term nursing care and higher cost of treatment.
An accurate and early diagnosis may induce changes in the clinical management of patients and may help families, and caregivers to make correct decisions and future plans resulting in a better management reducing carer burden and a better clinical outcome.
The recruitment at 20 centres in 8 European countries will start in the 3rd quarter of 2010 and will end in the 2nd quarter of 2012.
Participants meeting the inclusion and exclusion criteria will undergo a baseline diagnostic assessment at Visit 1 (V1) and then be randomized in a 2 to 1 ratio to either the active (DaTSCAN) group or to the control (no DaTSCAN) group. Participants assigned to the DaTSCAN group will undergo DaTSCAN imaging after baseline (V1). Participants will be assessed again at Visit 2 (V2; 8 weeks) and Visit 3 (V3; 24 weeks). The proportions of participants with a change in a DLB diagnostic category and/or confidence in diagnosis will be analysed. Participants in the control group will be eligible to receive DaTSCAN after completion of V3.
REC name
London - Central Research Ethics Committee
REC reference
10/H0718/71
Date of REC Opinion
2 Dec 2010
REC opinion
Further Information Favourable Opinion