Phase 2 N=50 Treatment

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

Alzheimer's Disease

Bottom Line

View on ClinicalTrials.gov: NCT00934050 ↗

Enrolled (actual)

Serious AEs

14.6%

Results posted

May 2015

Primary outcome: Primary: Treatment Emergent Adverse Events (TEAEs) — 21; 23 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ELND005 (scyllo-inositol) (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: OPKO Health, Inc.
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Emergent Adverse Events (TEAEs)	21; 23	—

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of ELND005 beyond the 18 months of treatment in original randomized and blinded clinical trail ELND005-AD201.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00934050). 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.