CompletedPhase 1

Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Elderly Healthy Subjects

A Phase I, Randomized, Double-blind (with-in Panel), Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Healthy Elderly Volunteers After Oral Multiple Ascending Doses of AZD0328

Lead sponsor

AstraZeneca

Asset

AZD0328

Listed sites

Recruiting sites

Enrollment

112

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 60-80

Primary endpoints

•Safety and tolerability of AZD0328 by assessment of vital signs•Safety and tolerability of AZD0328 by assessment of adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDD0190C00006

SecondaryEudractCT 2007-004598-25

NCT IDNCT00687141

Timeline

Milestones

Study start2007-11 (month precision)

Study first posted2008-05-30estimated

Primary completion2008-06actual (month precision)

Study completion2008-06actual (month precision)

Last update posted2010-12-10estimated

Assets

Drug assets

AZD0328

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

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, neurological, mental or gastrointestinal disorder or any other major disorder

•History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity

•Intake of any prescribed medicine or St John's Wort, except for occasional paracetamol and nasal anticongestant, within 3 weeks or use of over-the-counter drugs within 2 weeks before the first administration of study drug

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Safety and tolerability of AZD0328 by assessment of vital signs, laboratory variables and ECG

Time frame:Assessments taken at visit 1 (enrolment), during visit 2 (residential period) and follow up visit 3.

descriptive

Primary/protocol endpoint

Safety and tolerability of AZD0328 by assessment of adverse events

Time frame: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.

event count, event

Secondary/protocol endpoint

Determine the single and multiple dose pharmacokinetics (PK) of AZD0328

Time frame:PK sampling taken at defined timepoints during residential period.

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Evaluate the cognitive dose response relationship for AZD0328

Time frame:Psychometric test battery performed at defined timepoints during residential period.

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.