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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03605667
Recruitment Status : Active, not recruiting
First Posted : July 30, 2018
Last Update Posted : June 4, 2021
Alzheimer's Disease Cooperative Study (ADCS)
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: troriluzole Drug: Placebo oral capsule Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 31, 2018
Actual Primary Completion Date : November 23, 2020
Estimated Study Completion Date : January 23, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BHV-4157
troriluzole, 280 mg capsules, QD
Drug: troriluzole
Oral BHV-4157 will be given daily for up to 48 weeks
Other Name: 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

Primary Outcome Measures :
  1. The change in Alzheimers Disease Assessment Scale Cognitive Subscale (ADAS-Cog 11) from baseline to week 48 between the BHV-4157 treatment group and the placebo group [ Time Frame: Baseline to Week 48 ]

    Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog 11)

    The ADAS-Cog 11 evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing a letter in an envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained. The test is scored in terms of errors, with higher scores reflecting poorer performance and greater impairment. Scores can range from 0 (best) to 70 (worse).

  2. The change in Clinical Dementia Rating-Sum of Boxes (CDR-Sum of boxes) [ Time Frame: Baseline to week 48 ]
    The Clinical Dementia Rating-Sum of Boxes evaluates cognition and everyday functioning incorporating both informant input and direct assessment of performance.

Secondary Outcome Measures :
  1. To evaluate the changes in MRI (Quarc bilateral hippocampal volume) [ Time Frame: Measurement of change between co-registered Baseline and Week 48 MRI volume. ]
  2. To evaluate the change in the Neuropsychiatric Inventory (NPI) [ Time Frame: Change is measured by decrease from Baseline to week 48. A higher score indicates worsening of symptoms. ]
  3. To evaluate the change in Activities of Daily Living (ADL) [ Time Frame: Change is measured by decrease from Baseline to week 48. A higher score indicates a reduction in symptoms. ]
  4. To evaluate the change in Mini Mental Status Examination (MMSE) [ Time Frame: Change is measured by the change from baseline to Week 48. A decrease in the MMSE indicates a worsening of symptoms. ]
  5. To evaluate the overall safety and tolerability of BHV-4157. [ Time Frame: Change from Baseline to Week 48 in BHV-4157 subjects compared with placebo. ]
    This will be done by by assessing treatment related serious and non serious adverse events and adverse events.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03605667

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Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
Alzheimer's Disease Cooperative Study (ADCS)
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Responsible Party: Biohaven Pharmaceuticals, Inc. Identifier: NCT03605667    
Other Study ID Numbers: BHV4157-203
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders