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CompletedPhase 1

A Two-part Multiple Dose Study to Assess the Safety and Effects of AZD3293 in Healthy Elderly and Alzheimer's Patients

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Two-Part, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 in Plasma and Cerebrospinal Fluid in Healthy Male and Non-Fertile Female Elderly Volunteers and in Mild-to-Moderate Alzheimer Disease Patients

Lead sponsor

AstraZeneca

Asset

Lanabecestat

Listed sites

1

Recruiting sites

-

Enrollment

47

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•Adverse event monitoring•Assessment of vital signs and physical exams•Clinical laboratory tests

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 IDD5010C00002
NCT IDNCT01795339

Timeline

Milestones

Study first posted2013-02-20estimated
Study start2013-03 (month precision)
Primary completion2014-03actual (month precision)
Study completion2014-03actual (month precision)
Last update posted2014-04-03estimated

Assets

Drug assets

Lanabecestat

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Part 1: Healthy elderly male and female (of non-childbearing potential) subjects.
•Part 2: Male and non-fertile female AD patients.
•Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
•Part 2: Clinical diagnosis of probable AD according to the NINCDS-ADRDA criteria.
•Part 2: Manifestation of AD symptoms at least 6 months before randomization

Exclusion criteria

•Part 1: History or presence of psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders.
•Part 2: Significant disease affecting the CNS other than Alzheimer's disease, including but not limited to other dementias, other significant neurological or major psychiatric disease.
•History of use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs.
•Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products.
•History of neurological disease, including seizures, recent memory impairment, or clinically significant head injury.

Endpoints (9)

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
5
Fluid / digital biomarkers
2
Other (unclassified)
2

Fluid / digital biomarkers

2 endpoints
Secondary/protocol endpoint

Investigation of the effect of AZD3293 on plasma and cerebrospinal fluid (CSF) biomarkers relevant for Alzheimer Disease (AD)

Time frame:Up to 17 days

descriptive

Secondary/protocol endpoint

Investigation of the effect of AZD3293 on plasma and cerebrospinal fluid (CSF) biomarkers relevant for Alzheimer Disease (AD) in mild-moderate AD patients in comparison to elderly healthy volunteers

Time frame:Up to 17 days

descriptive

Safety / tolerability / PK

5 endpoints
Primary/protocol endpoint

Adverse event monitoring

Time frame:From Baseline up to 20 days

event count, event

Primary/protocol endpoint

Assessment of vital signs (blood pressure, pulse and body temperature) and physical exams

Time frame:From Baseline up to 20 days

descriptive

Primary/protocol endpoint

Clinical laboratory tests (chemistry, hematology, urinalysis, renal safety)

Time frame:From Baseline up to 20 days

descriptive

Secondary/protocol endpoint

Investigation of the multiple dose Pharmacokinetics for AZD3293 and its metabolite AZ13569724, including dose proportionality for AZD3293 following oral administration

Time frame:Up 17 days

threshold achievement, event

Secondary/protocol endpoint

Investigation of the Pharmacokinetics/Pharmacodynamics relationship of the effect of AZD3293 on biomarkers relevant for Alzheimer Disease (AD) in plasma

Time frame:Up to 17 days

descriptive

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Assessment of 12-lead digital electrocardiograms to measure rhythm, rate, morphology, QT/QTc interval

Time frame:Fron Baseline up to 20 days

descriptive

Primary/protocol endpoint/low confidence

Assessment of telemetry, as reported by Investigator Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame:From Baseline up to 20 days

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.