Study of BHV-4157 in Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: troriluzole; Placebo oral capsule
Intervention description: Oral BHV-4157 will be given daily for up to 48 weeks; Oral matching placebo will be given daily for up to 48 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 350.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

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, were administered orally once daily. Duration of treatment is 48 weeks in
      double-blind phase. There is also a screening period of up to 42 days; and a 4-week
      post-treatment observation period. Eligible participants who completed the double-blind
      treatment phase had the opportunity to receive open-label troriluzole for up to 48 weeks in
      an open-label extension (OLE) phase.
    

Eligibility 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.

          -  An Mini-Mental State Examination score of 14 to 24, inclusive, at screening.

          -  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.