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F-18 DPA-714

Phase 1

Diagnostic Imaging | Small molecule | Other |Bayer AG|Last Updated: Jul 31, 2013

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

F-18 DPA-714 · 1 trial · 1 indication

Phase 1 1
NCT01009359Evaluation of the Neuroinflammation Pattern of BAY85-8102 F-18, DPA-714 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of F 18, DPA-714 in Healthy VolunteersDiagnostic Imaging
COMPLETED22 Analytics
PHASE1COMPLETED
Evaluation of the Neuroinflammation Pattern of BAY85-8102 F-18, DPA-714 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of F 18, DPA-714 in Healthy Volunteers
Diagnostic ImagingUnlock trial analytics

Study Endpoints

Primary Endpoints

Discrimination of probable Alzhemimer disease patients from healthy volunteers by BAY85-81 F-18, DPA-714 brain PET imaging as evaluated by different quantification approaches
Day of Study tracer administration

Secondary Endpoints

Discrimination of probable Alzhemimer disease patients from healthy volunteers by BAY85-81 F-18, DPA-714 brain PET imaging as evaluated by visual analysis and standard parameters(e.g. Standardized Uptake Values = SUV)
Day of Study tracer administration
Electrocardiogram (ECG)
At least once within 8 days after treatment
Blood pressure
At least 2 times within 8 days after treatment
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Arm 3EXPERIMENTAL -

Interventions

NameTypeDescription
F-18 DPA-714 (BAY85-8102)DRUGAlzheimer Disease patients: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Able to give fully informed consent in writing * Males or females aged \>/= 50 years * No significant disease or drug use * Absence of any sign of dementia/cognitive impairment in neuropsychological examinationsPatients for brain imaging: * Patient and designee capable of givi...

Countries:FinlandNetherlands
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Competitive Landscape -Diagnostic and Imaging 9 trials (matched to "Diagnostic Imaging")

Frequently asked questions about F-18 DPA-714

What is F-18 DPA-714 used for?

F-18 DPA-714 is a small molecule diagnostic imaging agent in clinical development for use in diagnostic imaging. It is being studied to evaluate neuroinflammation patterns in patients with probable Alzheimer's disease compared to healthy volunteers, as well as for radiation dosimetry in healthy volunteers.

Who makes F-18 DPA-714?

F-18 DPA-714 is being developed by Bayer AG, a company traded under the ticker BAYRY. The drug is currently in Phase 1 clinical development for diagnostic imaging applications.

What phase is F-18 DPA-714 in?

F-18 DPA-714 is in Phase 1 clinical development. It is an investigational diagnostic imaging agent and has not been approved by regulatory authorities. One Phase 1 trial has been completed, involving 22 participants.

What clinical trials is F-18 DPA-714 in?

F-18 DPA-714 has one completed clinical trial, NCT01009359, which evaluated the neuroinflammation pattern of BAY85-8102 F-18, DPA-714 in probable Alzheimer's disease patients versus healthy volunteers, and radiation dosimetry in healthy volunteers. The trial enrolled 22 participants in Finland and the Netherlands.

Is F-18 DPA-714 the same as BAY85-8102?

Yes, F-18 DPA-714 is also known as BAY85-8102. The clinical trial NCT01009359 refers to the drug as BAY85-8102 F-18, DPA-714, confirming that these names refer to the same investigational diagnostic imaging agent.