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Phase 2 N=351 Randomized Quadruple-blind Treatment

ELND005 in Patients With Mild to Moderate Alzheimer's Disease

Alzheimer Disease

Bottom Line

View on ClinicalTrials.gov: NCT00568776 ↗
Enrolled (actual)
351
Serious AEs
20.2%
Results posted
Mar 2012
Primary outcome: Primary: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS) — -0.383; -0.350 Scores on a Scale — p=0.71

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Placebo Control (Drug); ELND005 (Drug)
Age
Adult, Older Adult · 50+ yrs
Sex
All
Sponsor
OPKO Health, Inc.
Primary completion
May 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)		 -0.383; -0.350 0.71
PRIMARY
Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)		 -0.369; -0.222 0.17
PRIMARY
Change From Baseline to Week 78 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)		 -9.467; -10.861 0.49
PRIMARY
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)		 -9.635; -8.987 0.77
SECONDARY
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)		 -8.239; -10.796 0.18
SECONDARY
Change in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)		 -2.742; -2.452 0.54
SECONDARY
Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)		 -6.132; -5.116 0.65

Summary

The purpose of this study is to evaluate the dose-related safety and efficacy of multiple oral dosages of ELND005 as treatment for Alzheimer's disease (AD).

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00568776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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