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Find more clinical trials

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

Start: July 31, 2018
End: December 2021
Enrollment: 292

What Is This Study About?

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.

Do I Qualify To Participate in This Study?

Minimum Age: 50 Years

Maximum Age: 85 Years

Must have:

  • 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

Must NOT have:

  • 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)

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Who Is the General Study Contact?

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

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Who Sponsors This Study?

Lead: Biohaven Pharmaceuticals, Inc.

Collaborator Sponsor

  • Alzheimer's Disease Cooperative Study (ADCS)

Source: ClinicalTrials.gov ID: NCT03605667

 

alzheimers.gov

An official website of the U.S. government, managed by the National Institutes on Aging at the National Institutes of Health