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CompletedPhase 2Results posted

ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease

A Long-Term Follow-Up Study of Oral ELND005 (AZD-103) in Subjects With Alzheimer's Disease

Lead sponsor

OPKO Health, Inc.

Asset

ELND005

Listed sites

38

Recruiting sites

-

Enrollment

103

actual

Study population

Alzheimer’s disease

Key I/E criterion

-

Primary endpoint

Treatment Emergent Adverse Events (TEAEs)

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 IDELND005-AD251
NCT IDNCT00934050

Timeline

Milestones

Study start2009-06 (month precision)
Study first posted2009-07-08estimated
Primary completion2011-06actual (month precision)
Study completion2011-06actual (month precision)
Results first posted2015-05-13estimated
Last update posted2019-10-21actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Inclusion criteria

This study is open only to subjects who have completed the week 78 visit in Study ELND005-AD201 while taking their assigned dose of study drug medication

Exclusion criteria

Subject has no new medical contraindications to continued participation in the study.

Endpoints (2)

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.

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Treatment Emergent Adverse Events (TEAEs)

Time frame:12 months

event count, event

Primary/registry result

Treatment Emergent Adverse Events (TEAEs)

Time frame:12 months

event count, event

Posted result

GroupValue (number), participantsReported bounds
Placebo/ELND005 250mg BIDn=26 Participants21-
250 mg/ELND005 250 mg BIDn=27 Participants23-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

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.