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BHV-4157 for Alzheimer's Disease (T2 Protect AD)

Recruiting

BHV-4157, also known as troriluzole, is an investigational drug that researchers are testing to determine if it can protect against, slow down, and potentially improve memory and thinking problems in adults with mild to moderate Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 85 Years All No
July 31, 2018
February 2, 2020
292

  • Diagnoses of probable Alzheimer's disease
  • Living in the community or in an assisted living facility (long-term care nursing facilities excluded)
  • Able to walk with or without a device, such as a cane or walker
  • Study partner who has contact three to four times per week, can be present for all clinic visits, and can assist in following study procedures
  • A brain magnetic resonance imaging (MRI) scan in past 6 months that's consistent with a diagnosis of Alzheimer's disease
  • Participants should be treated with a stable dose of FDA-approved Alzheimer's medications (galantamine, rivastigmine, donepezil, and/or memantine) for at least 3 months and should be expected to remain on a stable dose for trial duration
  • Participants who are not being treated with FDA-approved Alzheimer's medications, because of contraindications or previously failed treatment, are also eligible for inclusion if not expected to be treated with these medications for trial duration

  • Other neurodegenerative diseases and causes of dementias, including Parkinson's disease, Huntington's disease, vascular dementia, Creutzfeldt-Jakob disease, Lewy body dementia, progressive supranuclear palsy, AIDS (acquired immunodeficiency syndrome), or normal pressure hydrocephalus
  • Major depressive episode in past 6 months
  • Hepatic impairment or more severe liver impairment
  • Insulin-dependent diabetes or uncontrolled diabetes with HbA1c value more than 8 percent
  • Cancer or a malignant tumor in past 3 years, except stable prostate cancer or non-melanoma skin cancers
  • Participation in another clinical trial for an investigational agent and having taken study medication within 12 weeks of screening (unless confirmed placebo)

Participants will take either a capsule of the study drug or placebo once a day for almost 2 years. Researchers will measure cognitive function, such as memory and reasoning, through assessments given to participants over nine study visits. At the beginning and end of the study, participants will have an MRI brain scan.

For more information about this study or study sites, call 203-404-0410, email clinicaltrials@biohavenpharma.com, or visit www.t2protect.org.

Name City State Zip Status Primary Contact
Xenoscience, Inc.
Phoenix Arizona 85004 Not yet recruiting Lauren Batorski
602-274-9500
lbatorski@xenoscience.com
Banner Sun Health Research Institute
Sun City Arizona 85351 Not yet recruiting Kelly Clark
623-832-6527
Kelly.Clark2@bannerhealth.com
Arizona Health Sciences Center
Tucson Arizona 85724 Not yet recruiting Eddie Soto
520-626-3576
esoto@neurology.arizona.edu
Neurology Center of North Orange County
Fullerton California 92835 Recruiting Sheraz Mossa
714-879-7200
smossa@neurologyoc.com
University of California, San Diego
La Jolla California 92037 Recruiting Nana Kori
858-246-3279
nkori@ucsd.edu
University of Southern California
Los Angeles California 90033 Not yet recruiting Karen Stevens-Dagerman
323-442-7602
dagerman@usc.edu
SC3 Research Group - Pasadena
Pasadena California 91105 Not yet recruiting Anne Wilson
626-250-2070
anne.wilson@neurosearch.usa.com
Geriatric and Adult Psychiatry
Hamden Connecticut 06518 Recruiting Andrea DeClement
203-288-0414
a.declement@gapcare.org
Yale University School of Medicine
New Haven Connecticut 06510 Recruiting Carol Gunnoud
203-764-8100
carol.gunnoud@yale.edu
Ki Health PARTNERS LLC DBA NEW ENGLAND INSTITUTE FOR CLINICAL RESEARCH
Stamford Connecticut 06905 Not yet recruiting Jennifer Pereira
203-914-1903
jennifer@neinh.com
University of Miami
Miami Florida 33136 Recruiting Carmen Perez
305-243-0184
c.perez71@med.miami.edu
USF Health Byrd Alzheimer's Institute
Tampa Florida 33613 Not yet recruiting Kelly Rodrigo
813-974-4904
krodrig5@health.usf.edu
Bioclinica Research
The Villages Florida 32161 Not yet recruiting Nichole Skirvin
352-261-0901
Nichole.skirvin@bioclinica.com
Northwestern University
Chicago Illinois 60611 Recruiting Kristine Lipowski
312-503-2486
k-lipowski@northwestern.edu
Great Lakes Clinical Trials
Chicago Illinois 60640 Not yet recruiting Linda Zusevics
773-275-3500
lzusevics@greatlakesclinicaltrials.com
Southern Illinois University
Springfield Illinois 62702 Recruiting Barbara Lokaitis
217-545-9737
blokaitis@siumed.edu
Indiana University
Indianapolis Indiana 46202 Recruiting Scott Herring
317-963-7418
sherring@iupui.edu
University of Iowa
Iowa City Iowa 52242 Recruiting Karen Ekstam-Smith
319-353-5158
karen-ekstam@uiowa.edu
University of Kentucky
Lexington Kentucky 40504 Recruiting Amir Eilbiheary
859-323-3145
ael243@uky.edu
Pennington Biomedical Research Center
Baton Rouge Louisiana 70808 Not yet recruiting Angela Eldredge
225-763-3190
angela.eldredge@pbrc.edu
Northern Light Acadia Hospital
Bangor Maine 04401 Not yet recruiting Cindy Whited
207-973-7596
cwhited@northernlight.org
Johns Hopkins University
Baltimore Maryland 21224 Not yet recruiting Meghan Schultz
410-550-4258
mschul15@jhmi.edu
University of Michigan, Ann Arbor
Ann Arbor Michigan 48105 Recruiting Courtney Graft
734-763-2211
ccgraft@med.umich.edu
Michigan State University
East Lansing Michigan 48824 Recruiting Dennis Shubitowski
517-884-2286
dennis.shubitowski@hc.msu.edu
Galen Research
Chesterfield Missouri 63005 Not yet recruiting Farzad Qureshi, MD
314-546-5888
Dr_Qureshi99@Hotmail.com
Cleveland Clinic Lou Ruvo Center
Las Vegas Nevada 89106 Recruiting Alana Burns
702-483-6030
burnsa2@ccf.org
Princeton Medical Institute
Princeton New Jersey 08540 Recruiting Kaylee White
609-921-3555
kwhite@gminstitutes.com
James J. Peters VAMC
Bronx New York 10468 Recruiting Martin Ljekovic
212-659-8883
martin.ljekovic@mssm.edu
Columbia University
New York New York 10032 Not yet recruiting Ruth Tejeda
212-305-7661
rbt41@cumc.columbia.edu
University of Rochester Medical Center
Rochester New York 14620 Recruiting Nancy Kowalski
585-760-6569
Nancy_Kowalski@urmc.edu
SUNY Upstate Medical University Department of Geriatrics
Syracuse New York 13202 Not yet recruiting Linda Spillett
315-464-9017
spilletl@upstate.edu
Case Western Reserve University
Beachwood Ohio 44122 Recruiting Susie Sami
216-464-6467
susie.sami@Uhhospitals.org
Ohio State University
Columbus Ohio 43210 Recruiting Jennifer Icenhour
614-293-4969
Jennifer.Icenhour@osumc.edu
Tulsa Clinical Research
Tulsa Oklahoma 74104 Recruiting Sarah Fowler
918-743-2349
sarahf@tulsaclinicalresearch.com
Oregon Health and Science University
Portland Oregon 97239 Recruiting Katherine Mincks
503-494-6601
mincks@ohsu.edu
University of Pittsburgh
Pittsburgh Pennsylvania 15213 Recruiting Thomas Baumgartner
412-697-2716
baumgartnertc@upmc.edu
Geisinger Medical Clinic
Wilkes-Barre Pennsylvania 18711 Not yet recruiting Angela Whitmire
570-214-2834
awhitmire@geisinger.edu
Abington Neurological Associates
Willow Grove Pennsylvania 19090 Recruiting Anthony James
215-957-9250
anthonyjames.ana@gmail.com
Rhode Island Hospital
Providence Rhode Island 02903 Recruiting Sierra Irizarry
401-444-2421
sierra.irizarry@lifespan.org
CBRI, Roper Hospital
Charleston South Carolina 29401 Not yet recruiting Kendal Bittner
843-958-2618
kendal.bittner@rsfh.com
Vanderbilt Memory & Alzheimer's Center
Nashville Tennessee 37212 Recruiting Jaclyn Bogner
615-875-0590
jaclyn.bogner@vanderbilt.edu
University of Washington
Seattle Washington 98108 Not yet recruiting Anita Ranta
206-764-2339
rantaa@uw.edu

Biohaven Pharmaceuticals, Inc.

  • Alzheimer's Disease Cooperative Study (ADCS)

Name Phone Email
Robert Berman, MD 203-404-0410 clinicaltrials@biohavenpharma.com

NCT03605667

A Phase 2 Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of BHV-4157 in Patients With Mild to Moderate Alzheimer's Disease