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AZD4694

Phase 2

Alzheimer's Disease | Small molecule | Neurology |AstraZeneca PLC|Trials Updated: Jan 30, 2013

AZD4694 target and mechanism

ModalitySmall molecule

Also known as [18F]AZD4694

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment41

FDA Designations

No designations recorded

AZD4694 clinical trials

AZD4694 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00991419To Compare Positron Emission Tomography (PET) Measurements of Fibrillar Amyloid BurdenAlzheimer's Disease
COMPLETED25 Analytics
PHASE2COMPLETED
To Compare Positron Emission Tomography (PET) Measurements of Fibrillar Amyloid Burden
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

PET Measurements
Day 1 and Day 7
The Maximum Diagnostic Mass by assessing the visual read out of amyloid status according to and quantification of an [18F]AZD4694 PET image in a high mass experiment compared to the image in a low mass experiment in the same subject.
Visit 3

Measuring the maximum chemical mass not causing any significant alteration of the amyloid status (unit = micrograms)

Secondary Endpoints

Number of Adverse Events as a measure of Safety and tolerability of [18F]AZD4694
Range of Visits 3-5
Correlation between early uptake of [18F]AZD4694 images and cerebral blood flow images as measured by Arterial Spin Labeling Magnetic resonance imaging
Range of Screening Visit to Visit 4
Correlation between estimates of β-amyloid load in brain obtained using [18F]AZD4694 Position Emission Tomography imaging and concentrations of β-amyloid in Cerebrospinal fluid
Range of Screening Visit to Visit 4
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL\[18F\]4694
Part 1 Cohort 1EXPERIMENTALPatients with mild to moderate Alzheimer's Disease
Part 1 Cohort 2EXPERIMENTALPatients with mild to moderate Alzheimer's Disease. To run if Maximum Detective Mass is detected in cohort 1.
Part 2EXPERIMENTALHealthy Volunteers

Interventions

NameTypeDescription
[18F]AZD4694DRUG\[18F\]AZD4694 PET Ligand administered at Visit 1, 30 days following screening and at visit 4 for some of the participants.
[18Fluor]AZD4694OTHERLow mass dose below 5ug. High mass dose around 40 and 50 ug.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female, of any race or/ethnicity * ECG, vital signs, and clinical laboratory values are within normal limits at enrollment or deemed not clinically significant by the physician Exclusion Criteria: * Significant recent (within 6 months) history of neurological (includ...

Countries:United StatesSweden
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Frequently asked questions about AZD4694

What is AZD4694?

AZD4694 is an investigational small molecule PET imaging agent being developed by AstraZeneca for neurology applications. It is studied as a radioligand for positron emission tomography measurements of fibrillar amyloid burden, and it has also been evaluated for maximum diagnostic mass of [18Fluor]AZD4694. It is not an approved therapy.

What is AZD4694 used for in Alzheimer's disease?

AZD4694 is used in Alzheimer's disease research as a PET imaging radioligand to measure fibrillar amyloid burden in the brain. One Phase 2 study compared PET measurements of fibrillar amyloid burden, and a separate Phase 1 study assessed varying mass of AZD4694 on radioligand binding parameters in healthy volunteers and patients with Alzheimer's disease.

Who makes AZD4694?

AZD4694 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical studies evaluating the compound as a PET radioligand for amyloid imaging in Alzheimer's disease and related diagnostic mass assessments.

What phase is AZD4694 in?

AZD4694 has been studied in Phase 1 and Phase 2 clinical trials. The Phase 2 study, NCT00991419, compared PET measurements of fibrillar amyloid burden and is completed. The Phase 1 study, NCT01325402, examined varying mass of AZD4694 on radioligand binding parameters and is also completed. It is investigational and not approved.

What clinical trials is AZD4694 in?

AZD4694 has been evaluated in two completed trials. NCT00991419 was a Phase 2 study comparing PET measurements of fibrillar amyloid burden, enrolling 25 participants in the United States. NCT01325402 was a Phase 1 open-label PET study assessing varying mass of AZD4694 on radioligand binding parameters, enrolling 16 participants in Sweden.

Is AZD4694 the same as [18F]AZD4694?

Yes, [18F]AZD4694 is another name for AZD4694. The bracketed notation reflects the fluorine-18 radiolabel used in the compound for positron emission tomography imaging. Searches for either name refer to the same AstraZeneca PET radioligand being studied for fibrillar amyloid burden measurement.