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Phase II-III

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

  • Study HIC#:2000024024
  • Last Updated:07/15/2021

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.

Alzheimer’s disease research Center  http://www.alzheimers.yale.edu

  • Age50 years - 85 years
  • GenderBoth
  • Start Date01/07/2019
  • End Date01/02/2020

Trial Purpose and Description

This is a phase 2 double-blind placebo-controlled study designed to evaluate the efficacy and safety of BHV-4157 in mild to moderate Alzheimer's disease. Individuals age 50-85 with mild to moderate Alzheimer's disease will be randomized in a 1:1 fashion to receive active treatment (BHV-4157) or placebo taken orally once daily for 48 weeks. Volumetric MRIs will be performed at screening, week 24, and week 48. Participants will have the option of participating in an optional Lumbar Puncture/CSF substudy.

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.
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. 

Alzheimer’s disease research Center  http://www.alzheimers.yale.edu

Sub-Investigators

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