CompletedPhase 2Results posted

ELND005 in Patients With Mild to Moderate Alzheimer's Disease

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral ELND005 (AZD-103) in Alzheimer's Disease

Lead sponsor

OPKO Health, Inc.

Asset

ELND005

Listed sites

Recruiting sites

Enrollment

353

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 16-26

Primary endpoints

•Neuropsychological Test Battery (NTB) Z-score•Additional Analysis of Primary Outcome Measure•ADCS-Activities of Daily Living (ADCS-ADL)

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-AD201

NCT IDNCT00568776

Timeline

Milestones

Study start2007-12 (month precision)

Study first posted2007-12-06estimated

Primary completion2010-05actual (month precision)

Study completion2010-05actual (month precision)

Results first posted2012-03-29estimated

Last update posted2019-11-01actual

Assets

Drug assets

ELND005

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of probable AD

•Age 50 to 85 years, inclusive

•Mini-Mental Status Exam (MMSE) score of 16-26, inclusive

•Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD

•Fluency in English, French, or Spanish

•Stable doses of medications (cholinesterase inhibitors and memantine allowed)

•Caregiver is able to attend all study visits

Exclusion criteria

•Significant neurological disease other than AD

•Major psychiatric disorder

•Significant medical illness

•History of stroke or seizure

•History of a heart attack within the last 2 years

•Prior treatment with certain experimental medicines

•Presence of pacemakers or foreign metal objects in the eyes, skin, or body that would prevent patient from having MRI scan

Endpoints (14)

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

Global cognition

Function / daily living

Behavior / neuropsychiatric

Global cognition

8 endpoints

Primary/protocol endpoint

Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)

Time frame:Baseline and 78 weeks

change from baseline, improvement

Primary/protocol endpoint

Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)

Time frame:Baseline and 78 weeks

change from baseline, improvement

Primary/registry result

Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)

Time frame:Baseline and 78 weeks

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a Scale	Standard error
Placebo BIDn=82 Participants	-0.383	0.075
ELND005 250 mg BIDn=84 Participants	-0.350	0.074

Mean Difference (Final Values)0.0395% CI-0.14 - 0.21p0.71Mixed Models Analysis

Primary/registry result

Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)

Time frame:Baseline and 78 weeks

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a Scale	Standard error
Placebo BIDn=47 Participants	-0.369	0.093
ELND005 250 mg BIDn=49 Participants	-0.222	0.095

Mean Difference (Final Values)0.1595% CI-0.06 - 0.36p0.17Mixed Models Analysis

Secondary/protocol endpoint

Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)

Time frame:Baseline and 78 weeks

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)

Time frame:Baseline and 78 weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/registry result

Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)

Time frame:Baseline and 78 weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a Scale	Standard error
Placebo BIDn=82 Participants	-8.239	1.531
ELND005 250 mg BIDn=84 Participants	-10.796	1.540

Mean Difference (Final Values)-2.5695% CI-6.33 - 1.22p0.18Mixed Models Analysis

Secondary/registry result

Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)

Time frame:Baseline and 78 weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a Scale	Standard error
Placebo BIDn=82 Participants	-2.742	0.363
ELND005 250 mg BIDn=84 Participants	-2.452	0.357

Mean Difference (Final Values)0.2995% CI-0.63 - 1.21p0.54Mixed Models Analysis

Function / daily living

4 endpoints

Primary/protocol endpoint

Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)

Time frame:Baseline and 78 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Primary/protocol endpoint

Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS)

Time frame:Baseline and 78 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Primary/registry result

Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)

Time frame:Baseline and 78 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a Scale	Standard error
Placebo BIDn=82 Participants	-9.467	1.641
ELND005 250 mg BIDn=84 Participants	-10.861	1.604

Mean Difference (Final Values)-1.3995% CI-5.41 - 2.62p0.49Mixed Models Analysis

Primary/registry result

Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS)

Time frame:Baseline and 78 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a Scale	Standard error
Placebo BIDn=47 Participants	-9.635	1.779
ELND005 250 mg BIDn=49 Participants	-8.987	1.760

Mean Difference (Final Values)0.6595% CI-3.73 - 5.03p0.77Mixed Models Analysis

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)

Time frame:Baseline and 78 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)

Time frame:Baseline and 78 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a Scale	Standard error
Placebo BIDn=82 Participants	-6.132	1.851
ELND005 250 mg BIDn=84 Participants	-5.116	1.814

Mean Difference (Final Values)1.0295% CI-3.43 - 5.46p0.65Mixed Models Analysis

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.