A phase 2 randomized trial of ELND005, scyllo-inositol, in mild to moderate Alzheimer disease.

ABSTRACT:

Objective

This randomized, double-blind, placebo-controlled, dose-ranging phase 2 study explored safety, efficacy, and biomarker effects of ELND005 (an oral amyloid anti-aggregation agent) in mild to moderate Alzheimer disease (AD).

Methods

A total of 353 patients were randomized to ELND005 (250, 1,000, or 2,000 mg) or placebo twice daily for 78 weeks. Coprimary endpoints were the Neuropsychological Test Battery (NTB) and Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale. The primary analysis compared 250 mg (n =84) to placebo (n =82) after an imbalance of infections and deaths led to early discontinuation of the 2 higher dose groups.

Results

The 250 mg dose demonstrated acceptable safety. The primary efficacy analysis at 78 weeks revea

SUBMITTER: Salloway S 

PROVIDER: S-EPMC3179648 | biostudies-literature | 2011 Sep

REPOSITORIES: biostudies-literature