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Trial record 6 of 20 for:    Recruiting, Not yet recruiting, Active, not recruiting Studies | Alzheimer Disease | rochester, New York, U.S.

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

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ClinicalTrials.gov Identifier: NCT03605667
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
Alzheimer's Disease Cooperative Study (ADCS)
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE July 23, 2018
First Posted Date  ICMJE July 30, 2018
Last Update Posted Date October 11, 2019
Actual Study Start Date  ICMJE July 31, 2018
Estimated Primary Completion Date December 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
The change in ADAS-Cog 11 from baseline to week 48 between the BHV-4157 treatment group and the placebo group [ Time Frame: Baseline to Week 48 ]
Change History Complete list of historical versions of study NCT03605667 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of BHV-4157 in Alzheimer's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: troriluzole
    Oral BHV-4157 will be given daily for up to 48 weeks
    Other Name: BHV-4157
  • Drug: Placebo oral capsule
    Oral matching placebo will be given daily for up to 48 weeks
Study Arms  ICMJE
  • Experimental: BHV-4157
    troriluzole, 280 mg capsules, QD
    Intervention: Drug: troriluzole
  • Placebo Comparator: Placebo
    matching 280 mg placebo capsules, QD
    Intervention: Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 27, 2018)
292
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 20, 2020
Estimated Primary Completion Date December 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elyse Stock, MD 203-404-0410 clinicaltrials@biohavenpharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03605667
Other Study ID Numbers  ICMJE BHV4157-203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biohaven Pharmaceuticals, Inc.
Study Sponsor  ICMJE Biohaven Pharmaceuticals, Inc.
Collaborators  ICMJE Alzheimer's Disease Cooperative Study (ADCS)
Investigators  ICMJE Not Provided
PRS Account Biohaven Pharmaceuticals, Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP