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AZD0328

Phase 2

Alzheimer's Disease | Small molecule | Neurology |AstraZeneca PLC|Trials Updated: Dec 10, 2010

AZD0328 development status

Highest phase Phase 2 (NCT00669903)
Phase scored for AZNPhase 1
Registered trials 4 across 1 sponsor since May 2008

AZD0328 target and mechanism

Molecular targetCHRNA7
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment112

FDA Designations

No designations recorded

AZD0328 clinical trials

AZD0328 · 1 trial · 1 indication

Phase 1 1
NCT00687141Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Elderly Healthy SubjectsAlzheimer's Disease
COMPLETED112 Analytics
PHASE1COMPLETED
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Elderly Healthy Subjects
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of AZD0328 by assessment of vital signs, laboratory variables and ECG
Assessments taken at visit 1 (enrolment), during visit 2 (residential period) and follow up visit 3.
Safety and tolerability of AZD0328 by assessment of adverse events
Non serious adverse events will be collected from the start of residential period until the end of the study. Serious adverse events will be collected from signing of consent until end of study.

Secondary Endpoints

Determine the single and multiple dose pharmacokinetics (PK) of AZD0328
PK sampling taken at defined timepoints during residential period.
Evaluate the cognitive dose response relationship for AZD0328
Psychometric test battery performed at defined timepoints during residential period.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AZD0328DRUGOral solution administered orally once per day on day 1, and then day 3 through to day 14. Specific dose depends on dose panel.
PlaceboDRUGAdministered orally as a solution once per day on day 1, and then day 3 through to day 14.
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Eligibility Criteria

Age Range60 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Provision of signed informed consent * Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator Exclusion Criteria: * History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurologica...

Countries:Sweden
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Frequently asked questions about AZD0328

What is AZD0328?

AZD0328 is an investigational small molecule developed by AstraZeneca PLC for Alzheimer's disease. It is a Phase 1 central nervous system candidate and has not been approved for any indication. The compound has been studied in elderly healthy volunteers rather than in patients with diagnosed Alzheimer's disease.

What does AZD0328 target?

AZD0328 targets CHRNA7, the alpha-7 nicotinic acetylcholine receptor, and acts as an agonist at that receptor. CHRNA7 is a ligand-gated ion channel involved in cholinergic signaling in the brain, a pathway of interest in Alzheimer's disease research. Agonism at this target is the proposed mechanism of action for AZD0328.

Who makes AZD0328?

AZD0328 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical program for the compound. The drug is an internal AstraZeneca small molecule candidate rather than a partnered or licensed asset.

What phase is AZD0328 in?

AZD0328 is in Phase 1 development. It is an investigational drug and has not been approved by the FDA or any other regulator. The only recorded trial is a completed Phase 1 study, and no active trials are currently listed for the compound.

What clinical trials is AZD0328 in?

AZD0328 has been evaluated in one completed Phase 1 trial, NCT00687141, titled a study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD0328 in elderly healthy subjects. That trial enrolled 112 participants in Sweden, was randomized, double blind, and placebo controlled, and included participants aged 60 years and older.