Recent Updates
Recently added Catalysts

BAY1006578

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01153607Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy VolunteersPHASE1 COMPLETED 24Jun 1, 2010Oct 1, 2011Jan 21, 20132 Finland, Sweden
Unlock Drug Trial Details
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
Unlock Study Endpoints
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
Unlock Study Design Details
Eligibility Criteria
Age Range50 Years — 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
Unlock Eligibility Criteria
Competitive Landscape -Diagnostic and Imaging 9 trials