HART

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

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