Purpose

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

Eligibility

Eligible Ages
Between 50 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BHV-4157
troriluzole, 280 mg capsules, QD
  • Drug: troriluzole
    Oral BHV-4157 will be given daily for up to 48 weeks
    Other names:
    • 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

Recruiting Locations

Vanderbilt Memory & Alzheimer's Center
Nashville, Tennessee 37212
Contact:
Jaclyn Bogner
615-875-0590
jaclyn.bogner@vanderbilt.edu

More Details

NCT ID
NCT03605667
Status
Recruiting
Sponsor
Biohaven Pharmaceuticals, Inc.

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.