Dear HDTrials.org Member:

There is a Huntington’s Disease Study actively recruiting participants in many areas, some of which may be accessible to you or someone you know.  (Please see the list of sites and appropriate contact information at the end of this email).  It is called HART and is a study of ACR16. The following is a brief description of the study, the qualifications needed to participate, and contact information to learn more or to volunteer to participate in the study.

HART (A Multi-Center, North American, Randomized, Double-Blind, Parallel Group Study Comparing Three Doses of ACR16 Versus Placebo for the Symptomatic Treatment of Huntington Disease)

Study Purpose:  To assess the safety of three different doses of ACR16, an experimental drug for Huntington’s disease and to test drug effect on voluntary motor (movement) function, cognition (thinking ability), behavior, depression and anxiety.

Locations:  Thirty-five Huntington Study Group (HSG) research centers in the U.S. and Canada (see list and contact information below)

Participants Needed: 220 individuals

•    Age 30 years or more who have the diagnosis of Huntington’s disease at mild or moderate stages who meet a specified cognitive (thinking) ability, which will be determined at a screening visit.

•    Each participant must have a family member, or other caregiver partner to come to 2 study visits.

•    Participants should not be taking Xenazine (tetrabenazine) or neuroleptic medications (like Zyprexa or Risperdal) or certain antidepressants (Paxil, Prozac or Wellbrutrin).  Other antidepressants will be allowed.  More information on medication requirements can be obtained by a phone call to the investigator at your study location.

Trial Duration: Fourteen weeks and a total of 7 participant visits, 2 of which will require a partner or family member.  

Testing Procedures:

•    The first or screening visit includes a full physical and Huntington’s neurologic exam, blood, urine and electrocardiogram (EKG).  You must be in good health except for Huntington’s, and have subsequent normal lab test results to meet criteria for participation in the trial.  If all criteria are met and you are accepted into the trial you will be randomized (by a computer “flip of a coin”) to receive 1 of three different ACR16 doses or placebo and scheduled for your first trial visit.  

•    You will then have a total of 5 more return visits as part of the active drug clinical trial.  Only 2 of the study visits are intensive: the first baseline visit during which you first receive the first dosage of the drug, and the visit at 12 weeks when you have completed the drug course.  The other visits will be shorter, one of which is only for laboratory and EKG testing.

•    There will be a final visit 2 weeks after you have completed the drug portion of the clinical trial to assess your general medical health.

For more details please call one of the participating sites and please tell the coordinator that you learned about the study through HDTrials.org.

The United States of America

Location Site Name Contact Person Telephone No.

CA, La Jolla     University of California San Diego     Jody Goldstein     858-622-5854

CO, Littleton     Colorado Neurological Institute     Diane Erickson     303-762-6674

FL, Tampa     University of South Florida     Marcia McCall     813-974-6022

GA, Augusta     Medical College of Georgia     Sherry Banks     706-721-2798

IL, Chicago     Rush University Medical Center     Jeana Jaglin     312-942-5003

IN, Indianapolis     Indiana University     Joanne Belden     317-278-0868

IA, Iowa City     University of Iowa     Nancy Hale     319-353-4537

MA, Charlestown     Massachusetts General Hospital     Angela Hu     617-726-5486

MD, Baltimore     Johns Hopkins University     Claire Welsh     410-955-1349

MN, Golden Valley     Struthers Parkinson's Center     Sarah Lenarz     952-993-5495

MO, St. Louis     Washington University     Pat Deppen     314-362-8548

NY, Albany     Albany Medical College     Sharon Evans     518-262-6611

NY, Manhasset     North-Shore LIJ     Jean Ayan     516-562-2426

NY, Rochester     University of Rochester     Charlyne Hickey     585-341-7525

OH, Cincinnati     University of Cincinnati     Maureen Gartner     513-558-0018

OH, Columbus     Ohio State University     Allison Seward     614-688-8672

PA, Philadelphia     University of Pennsylvania     Lisa Altin     215-829-3582

TX, Dallas     University of Texas Southwestern Med Center     Amit Gode     214-648-0417

TX, Houston     Baylor College of Medicine     Alicia Palao     713-798-3974

CANADA

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AB, Edmonton     University of Alberta     Pamela King     780-735-8852

BC, Vancouver     University of British Columbia     Allison Coleman     604-822-7739

ON, London     London Health Sciences Centre     Julie Megens     519-663-3404

ON, Markham     Markham Centre for Movement Disorders     Jane Forsyth     905-472-7082

QC, Montreal     CHUM-Hospital Notre Dame     Hubert Poiffaut     514-890-8000 EXT 26511