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AZD8529

Phase 2

Schizophrenia | Small molecule | Psychiatry |AstraZeneca PLC|Trials Updated: Nov 1, 2011

AZD8529 development status

Highest phase Phase 2
Registered trials 6 across 1 sponsor since Sep 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment375

FDA Designations

No designations recorded

AZD8529 clinical trials

AZD8529 · 3 trials · 3 indications

Phase 2 1Phase 1 1Early Phase 1 1
NCT00921804Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia PatientsSchizophrenia
COMPLETED296 Analytics
PHASE2COMPLETED
Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

PANSS Total Score
Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
Functional magnetic resonance imaging (fMRI)
1 fMRI on Day 4; 1 fMRI on Day 21
Computerized neurocognitive tests
1 on Day -1; 1 on Day 1 and on Day 21
fMRI
3
Ketamine Infusion
3

Secondary Endpoints

PANSS Positive, Negative, and General Psychopathology Subscale Scores
Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
CGI-S
Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
Vital signs measurements, body weight, physical exam, clinical laboratory evaluations, ECGs, Extrapyramidal Symptoms, suicidal symptoms, cognition and incidence of adverse events
Prior to randomization (screening, admission to washout/run in, baseline) and Days 1, 8, 15, 22, and 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALAZD8529 40 mg
2PLACEBO_COMPARATORPlacebo
3OTHERRisperidone 4 mg (2mg on Day 1)

Interventions

NameTypeDescription
AZD 8529DRUG40mg oral daily capsule administered as a single dose in the morning for 28 days
RisperidoneDRUG4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days
Placebo to match AZD8529DRUGPlacebo to match AZD8529 administered as a daily capsule in the morning for 28 days during the treatment period and also during the 3-7 day washout or run-in period
Placebo to match risperidoneDRUGPlacebo to match risperidone administered as a daily capsule in the evening for 28 days during the treatment period and also during the 3-7 day washout or run-in period
AZD8529DRUG2 capsules by mouth for 3 days
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patient will need to read, understand and sign an informed consent prior to any study specific procedures * Patient will have certain schizophrenia symptoms deemed by the investigator as appropriate for the study entry Exclusion Criteria: * Patients will be excluded based on...

Countries:United States
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Frequently asked questions about AZD8529

What is AZD8529?

AZD8529 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN) for neurological conditions. It has been studied in schizophrenia and in memory impairment, including ketamine-induced working memory impairment in healthy volunteers. It is a Phase 1 stage asset and is not described as approved.

What is AZD8529 used for in schizophrenia?

AZD8529 has been studied for schizophrenia, including effects on cognition and negative symptoms. A completed Phase 2 trial, NCT00921804, assessed efficacy, safety, and tolerability in 296 adult schizophrenia patients, and a completed Phase 1 trial, NCT00986531, examined cognition and negative symptoms in 59 patients.

Who makes AZD8529?

AZD8529 is developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the clinical trials of the compound in schizophrenia and memory impairment conducted in the United States.

What phase is AZD8529 in?

AZD8529 is in Phase 1 development overall. Its trial record includes two completed Phase 1 studies, NCT00986531 and NCT00985933, plus a completed Phase 2 study, NCT00921804. No trials are currently listed as active, and the compound is investigational rather than approved.

What clinical trials is AZD8529 in?

AZD8529 has been evaluated in three completed trials: NCT00986531 in schizophrenia, NCT00985933 in healthy volunteers with ketamine-induced working memory impairment, and NCT00921804 in adult schizophrenia patients. Total enrollment across these studies was 355 participants, and the trials used randomized, double-blind, placebo-controlled designs.

Is AZD8529 the same as AZD 8529?

Yes, AZD8529 and AZD 8529 refer to the same investigational compound from AstraZeneca PLC. The spacing differs only in how the code name is written, so searches for either form point to the same small molecule studied in schizophrenia and memory impairment.