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Trial record 6 of 20 for:    Recruiting, Not yet recruiting, Active, not recruiting Studies | Alzheimer Disease | rochester, New York, U.S.

Study of BHV-4157 in Alzheimer's Disease (T2 Protect AD)

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ClinicalTrials.gov Identifier: NCT03605667
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
Alzheimer's Disease Cooperative Study (ADCS)
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Brief Summary:
Preclinical models suggest that riluzole, the active metabolite of BHV-4157, may protect from AD-related pathology and cognitive dysfunction. Titrated dose of BHV-4157 to 280 mg, or placebo, taken orally once daily. Duration of treatment is 48 weeks. There is also a screening period of up to 42 days; and a 4-week post-treatment observation period.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: troriluzole Drug: Placebo oral capsule Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : December 5, 2020
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BHV-4157
troriluzole, 280 mg capsules, QD
Drug: troriluzole
Oral BHV-4157 will be given daily for up to 48 weeks
Other Name: BHV-4157

Placebo Comparator: Placebo
matching 280 mg placebo capsules, QD
Drug: Placebo oral capsule
Oral matching placebo will be given daily for up to 48 weeks




Primary Outcome Measures :
  1. The change in Alzheimers Disease Assessment Scale Cognitive Subscale (ADAS-Cog 11) from baseline to week 48 between the BHV-4157 treatment group and the placebo group [ Time Frame: Baseline to Week 48 ]

    Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog 11)

    The ADAS-Cog 11 evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing a letter in an envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained. The test is scored in terms of errors, with higher scores reflecting poorer performance and greater impairment. Scores can range from 0 (best) to 70 (worse).




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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Age 50 to 85 (inclusive) at screening
  • Diagnosed with probable Alzheimer's disease dementia: Core clinical criteria in accordance with NIA/Alzheimer's Association Guidelines.
  • Living in the community (includes assisted living facilities, but excludes long-term care nursing facilities).
  • Ambulatory, or able to walk with an assistive device, such as a cane or walker.
  • Participants must have a study partner who has frequent interaction with them (approximately >3-4 times per week), will be present for all clinic visits, and can assist in compliance with study procedures.
  • A brain MRI scan within 6 months of screening consistent with a diagnosis of Alzheimer's disease.
  • Participants should be treated with a stable dosage regimen of FDA-approved AD medications (acetylcholinesterase inhibitors (AchEI) and/or memantine) for at least 3 months prior to screening. Participants should be expected to remain on a stable dosage regimen of these medications for the duration of the trial.
  • Participants who are not being treated with FDA-approved AD medications at the time of screening, because they have contraindications to these medications, or because they have previously failed treatment with these medications, are also eligible for inclusion, if it is expected that they will not be treated with these medications for the duration of the trial.

Key Exclusion Criteria:

  • Hepatic impairment defined as Child-Pugh class of A or more severe liver impairment.
  • Other neurodegenerative diseases and causes of dementias, including Parkinson's disease and Huntington's disease, vascular dementia, CJD (Creutzfeldt-Jakob disease), LBD (Lewy Body dementia), PSP (Progressive Supranuclear Palsy), AIDS (Acquired Immunodeficiency Syndrome), or NPH (normal pressure hydrocephalus).
  • History of a major depressive episode within the past 6 months of screening.
  • Insulin-dependent diabetes or uncontrolled diabetes with HbA1c value >8.0 %.
  • Cancer or a malignant tumor within the past 3 years, except patients who underwent potentially curative therapy with no evidence of recurrence for >3 years. Patients with stable prostate cancer or non-melanoma skin cancers are not excluded.
  • Participation in another clinical trial for an investigational agent and having taken at least one dose of study medication, unless confirmed as having been on placebo, within 12 weeks prior to screening. The end of a previous investigational trial is defined as the date of the last dose of an investigational agent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03605667


Contacts
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Contact: Elyse Stock, MD 203-404-0410 clinicaltrials@biohavenpharma.com

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Locations
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United States, Arizona
Xenoscience, Inc. Recruiting
Phoenix, Arizona, United States, 85004
Contact: Lauren Batorski    602-274-9500 ext x406    lbatorski@xenoscience.com   
Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact: Sandy Quintanilla    602-406-7054    Sandy.Quintanilla@DignityHealth.org   
Banner Sun Health Research Institute Recruiting
Sun City, Arizona, United States, 85351
Contact: Kelly Clark    623-832-6527    Kelly.Clark2@bannerhealth.com   
United States, California
Neurology Center of North Orange County Recruiting
Fullerton, California, United States, 92835
Contact: Sheraz Mossa    714-879-7200 ext 106    smossa@neurologyoc.com   
University of California, San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Nana Kori    858-246-3279    nkori@ucsd.edu   
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Karen Stevens-Dagerman    323-442-7602    dagerman@usc.edu   
SC3 Research Group - Pasadena Recruiting
Pasadena, California, United States, 91105
Contact: Anne Wilson    626-250-2070 ext X776    anne.wilson@neurosearch.usa.com   
United States, Connecticut
Geriatric and Adult Psychiatry Recruiting
Hamden, Connecticut, United States, 06518
Contact: Andrea DeClement    203-288-0414    a.declement@gapcare.org   
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Carol Gunnoud    203-764-8100    carol.gunnoud@yale.edu   
Ki Health PARTNERS LLC DBA NEW ENGLAND INSTITUTE FOR CLINICAL RESEARCH Recruiting
Stamford, Connecticut, United States, 06905
Contact: Jennifer Pereira    203-914-1903    jennifer@neinh.com   
United States, Florida
Brain Matters Research Recruiting
Delray Beach, Florida, United States, 33445
Contact: Elizabeth Diebel    561-374-8461 ext 117    ediebel@ergclinical.com   
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Carmen Perez    305-243-0184    c.perez71@med.miami.edu   
USF Health Byrd Alzheimer's Institute Recruiting
Tampa, Florida, United States, 33613
Contact: Kelly Rodrigo    813-974-4904    krodrig5@health.usf.edu   
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Kristine Lipowski    312-503-2486    k-lipowski@northwestern.edu   
Great Lakes Clinical Trials Recruiting
Chicago, Illinois, United States, 60640
Contact: Linda Zusevics    773-275-3500    lzusevics@greatlakesclinicaltrials.com   
Southern Illinois University Recruiting
Springfield, Illinois, United States, 62702
Contact: Barbara Lokaitis    217-545-9737    blokaitis@siumed.edu   
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Scott Herring    317-963-7418    sherring@iupui.edu   
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Karen Ekstam-Smith    319-353-5158    karen-ekstam@uiowa.edu   
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40504
Contact: Amir Eilbiheary    859-323-3145    ael243@uky.edu   
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Angela Eldredge    225-763-3190    angela.eldredge@pbrc.edu   
United States, Maine
Northern Light Acadia Hospital Recruiting
Bangor, Maine, United States, 04401
Contact: Cindy Whited    207-973-7596    cwhited@northernlight.org   
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: Meghan Schultz    410-550-4258    mschul15@jhmi.edu   
United States, Michigan
University of Michigan, Ann Arbor Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Courtney Graft    734-763-2211    ccgraft@med.umich.edu   
Michigan State University Recruiting
East Lansing, Michigan, United States, 48824
Contact: Dennis Shubitowski    517-884-2286    dennis.shubitowski@hc.msu.edu   
United States, Missouri
Galen Research Recruiting
Chesterfield, Missouri, United States, 63005
Contact: Farzad Qureshi, MD    314-546-5888    Dr_Qureshi99@Hotmail.com   
United States, Nevada
Cleveland Clinic Lou Ruvo Center Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Heather Hudson    702-483-6030    Hudsonh@ccf.org   
United States, New Jersey
Princeton Medical Institute Recruiting
Princeton, New Jersey, United States, 08540
Contact: Kaylee White    609-921-3555 ext 17    kwhite@gminstitutes.com   
United States, New York
James J. Peters VAMC Recruiting
Bronx, New York, United States, 10468
Contact: Juliana Gamino    718-584-9000 ext 1759    juliana.gamino@va.gov   
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Ruth Tejeda    212-305-7661    rbt41@cumc.columbia.edu   
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14620
Contact: Nancy Kowalski    585-760-6569    Nancy_Kowalski@urmc.edu   
SUNY Upstate Medical University Department of Geriatrics Recruiting
Syracuse, New York, United States, 13202
Contact: Linda Spillett    315-464-9017    spilletl@upstate.edu   
United States, Ohio
Case Western Reserve University Recruiting
Beachwood, Ohio, United States, 44122
Contact: Susie Sami    216-464-6467    susie.sami@Uhhospitals.org   
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Jennifer Icenhour    614-293-4969    Jennifer.Icenhour@osumc.edu   
United States, Oklahoma
Tulsa Clinical Research Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Sarah Fowler    918-743-2349 ext 108    sarahf@tulsaclinicalresearch.com   
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Katherine Mincks    503-494-6601    mincks@ohsu.edu   
United States, Pennsylvania
Keystone Clinical Studies, LLC Recruiting
Norristown, Pennsylvania, United States, 19403
Contact: Laura Cekot    610-277-8073    laura.cekot@keystoneclinicalstudies.com   
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Thomas Baumgartner    412-697-2716    baumgartnertc@upmc.edu   
Geisinger Medical Clinic Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Angela Whitmire    570-214-2834    awhitmire@geisinger.edu   
Abington Neurological Associates Recruiting
Willow Grove, Pennsylvania, United States, 19090
Contact: Anthony James    215-957-9250    anthonyjames.ana@gmail.com   
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Sierra Irizarry    401-444-2421    sierra.irizarry@lifespan.org   
United States, South Carolina
CBRI, Roper Hospital Recruiting
Charleston, South Carolina, United States, 29401
Contact: Kendal Bittner    843-958-2618    kendal.bittner@rsfh.com   
United States, Tennessee
Vanderbilt Memory & Alzheimer's Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Jaclyn Bogner    615-875-0590    jaclyn.bogner@vanderbilt.edu   
United States, Texas
The Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases,University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Vinutha Ganapathy    210-450-8224    GanapathyV@UTHSCSA.edu   
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98108
Contact: Anita Ranta    206-764-2339    rantaa@uw.edu   
Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
Alzheimer's Disease Cooperative Study (ADCS)

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Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03605667     History of Changes
Other Study ID Numbers: BHV4157-203
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders