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DatSCAN

Phase 3

Lewy Body Dementia | Small molecule | Neurology |GE HealthCare Technologies Inc.|Last Updated: May 16, 2007

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment326

FDA Designations

No designations recorded

Clinical trial landscape

DatSCAN · 1 trial · 4 indications

Phase 3 1
NCT00209456Dopamine Transporter Scintigraphy Imaging (DAT-Imaging) in Patients With Lewy Body DementiaLewy Body Dementia
COMPLETED326 Analytics
PHASE3COMPLETED
Dopamine Transporter Scintigraphy Imaging (DAT-Imaging) in Patients With Lewy Body Dementia
Lewy Body DementiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Sensitivity and specificity of DaTSCAN SPECT scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB dementia subjects.

Secondary Endpoints

Accuracy, positive predictive value and negative predictive value of DaTSCAN SPECT
Semi-quantitative analysis of the striatal uptake ratios of DaTSCAN SPECT images.
Impact of DaTSCAN SPECT analysis on the confidence of diagnosis.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Interventions

NameTypeDescription
DatSCANDRUG -
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Eligibility Criteria

Age Range55 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 Comm...

Countries:Germany
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Frequently asked questions about DatSCAN

What is DatSCAN used for in Lewy Body Dementia?

DatSCAN is an investigational small molecule being studied for use in Lewy Body Dementia. It is a dopamine transporter scintigraphy imaging agent, also known as DAT-imaging, intended to help in the evaluation of patients with this condition. The drug is currently in Phase 3 clinical development.

What does DatSCAN target?

DatSCAN targets the dopamine transporter, a protein involved in the reuptake of dopamine in the brain. By binding to this transporter, DatSCAN enables visualization of dopamine nerve terminals through scintigraphy imaging, which may aid in the assessment of Lewy Body Dementia.

Who makes DatSCAN?

DatSCAN is being developed by GE HealthCare Technologies Inc., a company publicly traded under the ticker GEHC. The company is conducting clinical research to evaluate the drug's potential in the field of neurology, specifically for Lewy Body Dementia.

What phase is DatSCAN in?

DatSCAN is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial for DatSCAN has been completed, and the drug remains under evaluation for its intended use in Lewy Body Dementia.

What clinical trials is DatSCAN in?

DatSCAN has one completed Phase 3 clinical trial registered under NCT00209456, titled "Dopamine Transporter Scintigraphy Imaging (DAT-Imaging) in Patients With Lewy Body Dementia." This trial enrolled 326 participants in Germany, including patients with Lewy Body Dementia, non-DLB dementia, Alzheimer's, and vascular dementia.

Is DatSCAN the same as DAT imaging?

DatSCAN is associated with dopamine transporter scintigraphy imaging, often referred to as DAT-imaging. The clinical trial for DatSCAN specifically uses this imaging technique to evaluate patients with Lewy Body Dementia. The drug itself is the imaging agent used in this diagnostic procedure.