2CARE is the Phase III trial for CoQ-10 that is testing the effectiveness of high doses of this supplement in symptomatic Huntington's individuals with early or mid-stage disease who have maintained independence and are free of active psychiatric symptoms.  

Trial status: Started in 2008, is actively recruiting.  Will need 608 participants.

Sponsor: National Institutes of Health

Trial design: A randomized, double-blind, placebo controlled trial of high dose (2400 mg) CoQ-10 compared to placebo in 608 participants.  The trial requires 14 visits and 10 telephone contacts over 5 years, but will be stopped earlier if benefit is shown.  Other psychotropic medications and tetrabenazine are allowed if stable dosing has been obtained.

Location: Recruiting is ongoing at 48 Huntington Study Group centers who are participating in this study.

Outcome measures: Comparison of UHDRS (a combination of motor, cognitive,and psychiatric tests) and functional capacity (TFC).  It is change in TFC for those on CoQ-10 compared to placebo that will be used to define effectiveness.  And MRI of the brain at the beginning and end of the trial will be requested only at specified centers.