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
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.
– 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
– 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.
- Neurology Center of North Orange County, Fullerton, California, United States, 92835
- University of California, San Diego, La Jolla, California, United States, 92037
- University of Southern California, Los Angeles, California, United States, 90033
- SC3 Research Group – Pasadena, Pasadena, California, United States, 91105