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radioligand AZD4694

Phase 1

Alzheimer's Disease | Small molecule | Neurology |AstraZeneca PLC|Last Updated: Oct 23, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00838877Positron Emission Tomography (PET) Study With [18F]AZD4694 and [11C]AZD2184, Candidate PET Ligands for Aβ AmyloidPHASE1 COMPLETED 26Jan 1, 2009Oct 1, 2009Oct 23, 20092 Sweden
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Study Endpoints
Primary Endpoints
Positron emission tomography using the radioligand [18F]AZD4694 and/or [11C]AZD2184
Radioligand [18F]AZD4694: 1-2 PET examinations for AD patients and 1 PET examination for healthy volunteers. Whole body dosimetri for some healthy volunteers. - Radioligand [11C]AZD2184: 1 PET for AD patients respective healthy volunteers.
Secondary Endpoints
To assess safety and tolerability of [18F]AZD4694 and the study procedures, by assessment of adverse events, vital signs, and laboratory variables.
3-4 visits with tests for AD patients respective healthy volunteers. All tests are not done at every visit.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
radioligand [18F]AZD4694DRUGsingle dose of iv. admin. 1-2 times per subject
radioligand [11C]AZD2184DRUGsingle dose of iv admin. 1 time per subject
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Eligibility Criteria
Age Range50 Years — 85 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Alzheimer's Disease patients - 50-85 years, mild to moderate AD: MMSE ≥16 and ≤ 26, clinical progression of AD over 12 months. * Healthy volunteers: - 50-75 years * BMI 18 and 30 m2/kg * Clinically normal physical findings including supine blood pressure and pulse rate. Exclu...

Countries:Sweden
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