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F-18 DPA-714

Phase 1

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

F-18 DPA-714 target and mechanism

ModalitySmall molecule

Also known as F-18 DPA-714 (BAY85-8102)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

F-18 DPA-714 clinical trials

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 10 trials (matched to "Diagnostic Imaging")

No competing companies are currently tracked in active development for Diagnostic and Imaging.
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Frequently asked questions about F-18 DPA-714

What is F-18 DPA-714?

F-18 DPA-714 is an investigational small molecule positron emission tomography (PET) imaging agent developed by Bayer AG. It is being studied as a diagnostic imaging tool, including evaluation of neuroinflammation patterns in patients with probable Alzheimer's disease compared with healthy volunteers.

What is F-18 DPA-714 used for?

F-18 DPA-714 is being developed for diagnostic imaging. Its only recorded clinical study evaluated neuroinflammation patterns in patients with probable Alzheimer's disease versus healthy volunteers, and also assessed radiation dosimetry of the agent in healthy volunteers.

Who makes F-18 DPA-714?

F-18 DPA-714 is developed by Bayer AG, which trades over the counter in the United States under the ticker BAYRY. The compound is also referenced by Bayer's internal code BAY85-8102.

What phase is F-18 DPA-714 in?

F-18 DPA-714 is in Phase 1 clinical development. It is an investigational imaging agent and has not been approved by the FDA. Its single recorded Phase 1 trial has been completed, and no trials are currently active.

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

F-18 DPA-714 has been studied in one completed Phase 1 trial, NCT01009359, titled 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. It 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, Bayer's internal designation for the same compound. Both names refer to the same fluorine-18 labeled PET imaging agent.