NCT00568776

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed description

ELND005 (formerly known as AZD-103), scyllo-inositol, is being investigated as an orally administered treatment for AD. ELND005 may prevent or inhibit the build up of amyloid protein in the brains of AD patients. This is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy study of oral ELND005 in male and female participants aged 50-85 years with mild to moderate AD. Approximately 340 patients will be enrolled into the study at approximately 65 study sites. Patients will be randomized to receive either ELND005 or placebo. Each patient's participation will last approximately 18 months.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Placebo Control	ELND005 matched placebo capsules for oral administration, bid for 78 weeks
DRUG	ELND005	ELND005 capsules for oral administration at a dose of 2000 mg bid for 78 weeks
DRUG	ELND005	ELND005 capsules for oral administration at a dose of 250 mg bid for 78 weeks
DRUG	ELND005	ELND005 capsules for oral administration at a dose of 1000 mg bid for 78 weeks

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2007-12-06
• Last updated: 2019-11-01
• Results posted: 2012-03-29

Locations

62 sites across 2 countries: United States, Canada