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Radioligand AZD2995

Phase 1

Alzheimer´s Disease | Small molecule | Neurology |AstraZeneca PLC|Last Updated: Jan 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00692705Positron Emission Tomography (PET) Study With [11C]AZD2995 and [11C]AZD2184, Candidate PET Ligands for β AmyloidPHASE1 COMPLETED 13Jan 1, 2008Dec 1, 2008Jan 23, 20091 Sweden
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Study Endpoints
Primary Endpoints
Positron emission tomography using the radioligand (11C)AZD2995 or (11C)AZD2184
Radioligand (11C)AZD2995.1-2 PET examinations for AD patients and 1 PET examination for healthy volunteers. - Radioligand (11C) AZD2184.One PET for AD patients respective healthy volunteers.
Secondary Endpoints
To assess safety and tolerability of [11C]AZD2995, [11C]AZD2184 and the study procedures, by assessment of adverse events, vital signs and laboratory variables.
3-4 visits with tests for the AD patients. 3 visits with tests for the 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
1OTHERAlzheimer's Disease (AD) patients
2OTHERHealthy volunteers
Interventions
NameTypeDescription
Radioligand (11C)AZD2995DRUGSingle dose of i.v solution. 1-2 times for AD patients. Once for healthy volunteers.
Radioligand (11C)AZD2184DRUGSingle dose of i.v solution. Once for AD patients respective healthy volunteers.
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Eligibility Criteria
Age Range20 Years — 85 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Alzheimer´s Disease patients - 50-85 years- mild to moderate AD, clinical progression of AD over 12 months. * Healthy male volunteers: - Age 20-50 years, Body Mass Index: 18-30 kg/m2. * Clinically normal physical findings including normal blood pressure and pulse rate. Exclus...

Countries:Sweden
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