PRECREST: a phase II prevention and biomarker trial of creatine in at-risk Huntington disease.

ABSTRACT:

Objective

To assess the safety and tolerability of high-dose creatine, the feasibility of enrolling premanifest and 50% at-risk subjects in a prevention trial, and the potential of cognitive, imaging, and blood markers.

Methods

Sixty-four eligible consenting participants were randomly allocated (1:1) to 15 g twice daily of creatine monohydrate or placebo for a 6-month double-blind phase followed by a 12-month open-label extension. Subjects included premanifest (tested) and at-risk (not tested) individuals without clinical symptoms or signs of Huntington disease (HD). Primary outcomes were safety and tolerability. Exploratory endpoints included fine motor, visuospatial, and memory performance; structural and diffusion MRI; and selected blood markers.

Results

Forty-seve

SUBMITTER: Rosas HD 

PROVIDER: S-EPMC3959748 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature