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BAY1006578

Phase 1

Diagnostic Imaging | Small molecule | Other |Lantheus Holdings, Inc.|Last Updated: Jan 21, 2013

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

BAY1006578 · 1 trial · 1 indication

Phase 1 1
NCT01153607Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy VolunteersDiagnostic Imaging
COMPLETED24 Analytics
PHASE1COMPLETED
Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy Volunteers
Diagnostic ImagingUnlock trial analytics

Study Endpoints

Primary Endpoints

Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by different quantification approaches
Day 1 - day of study tracer administration

Secondary Endpoints

Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by visual analysis and by standard parameters (e.g. Standardized Uptake Values=SUV)
Day 1 - 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
BAY1006578DRUGAlzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET
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Eligibility Criteria

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

Inclusion Criteria: * All: * Males or females aged \>/- 50 years * Participants must be able to understand the information provided on purpose and conduct of the clinical study, must be capable of giving fully informed consent in writing, and have read and signed the informed consent prior to ...

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

Frequently asked questions about BAY1006578

What is BAY1006578 used for?

BAY1006578 is an investigational small molecule being developed for diagnostic imaging. It was evaluated in a Phase 1 clinical trial for its diagnostic potential in probable Alzheimer's disease patients compared to healthy volunteers, as well as for radiation dosimetry in healthy volunteers.

Who makes BAY1006578?

BAY1006578 is being developed by Lantheus Holdings, Inc., a company traded on the NASDAQ under the ticker LNTH. The drug is currently in Phase 1 clinical development as an investigational diagnostic imaging agent.

What phase is BAY1006578 in?

BAY1006578 is in Phase 1 clinical development. It is an investigational drug and is not approved by the FDA. One Phase 1 trial has been completed, and there are no active or ongoing trials for this asset at this time.

What clinical trials is BAY1006578 in?

BAY1006578 has one completed clinical trial, registered as NCT01153607. This Phase 1 study evaluated the diagnostic potential of BAY1006578 in probable Alzheimer's disease patients versus healthy volunteers and assessed radiation dosimetry in healthy volunteers. The trial enrolled 24 participants in Finland and Sweden.

Is BAY1006578 the same as any other drug?

BAY1006578 is the primary name for this investigational diagnostic imaging agent. No alternative names have been reported for this compound in the available clinical trial information.