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CompletedNCT03605667T2 Protect ADUpdated Dec 6, 2023Results posted

Study of BHV-4157 in Alzheimer's Disease

A Phase 2 interventional study of troriluzole and Placebo oral capsule in Alzheimer Disease, sponsored by Biohaven Pharmaceuticals, Inc.. Completed at 44 sites in United States. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-12-06.

Sponsored by Biohaven Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
350
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer Disease

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's enrollment of 350 is above the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Biohaven Pharmaceuticals, Inc. is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 6 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
350 participants (actual)

Study arms

  • Experimental
    BHV-4157

    troriluzole, 280 mg (2 x 140 mg) capsules, QD

    Drug: troriluzole

  • Placebo comparator
    Placebo

    matching 280 mg (2 x 140 mg) placebo capsules, QD

    Drug: Placebo oral capsule

Interventions

  • Drugtroriluzole

    Oral BHV-4157 will be given daily for up to 48 weeks

    Also known as: BHV-4157

  • DrugPlacebo oral capsule

    Oral matching placebo will be given daily for up to 48 weeks

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score at Week 48

    The ADAS-Cog is a structured scale that 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 were also obtained. The test was scored in terms of errors on a scale ranging from 0 (best) to 70 (worse), with higher scores indicate poorer performance and greater impairment.

    Time frame: Baseline (Day 1) and Week 48

  2. Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-Sum of Boxes) Total Score at Week 48

    The CDR-sum of boxes is a validated composite rating of cognition and everyday functioning used in longitudinal AD research which incorporates both informant input and direct assessment of performance. It assesses through semi-structured interview 3 cognitive domains including memory, orientation, and judgement/problem solving and 3 everyday functional domains including community affairs, home and hobbies and personal care. The individual domain score ranging from 0 (none) to 3 (severe) but the scores in each of these were combined to obtain a composite score (sum of boxes) ranging from 0 (best) to 18 (worst), with higher scores indicate poorer performance and greater impairment. The individual domain scores are added to create a sum of the box scores.

    Time frame: Baseline (Day 1) and Week 48

Secondary outcomes

  1. Change From Baseline in Magnetic Resonance Imaging (MRI) Hippocampal Volume at Week 48

    Volumetric MRI allows the in vivo assessment of brain structure volume and provides a measure of atrophy rate. Results from MRI studies suggest that the patterns of atrophy in AD, which mirror the pathological progression of the disease, can reliably be detected and tracked across time. Hippocampal volume derived from MRI correlates with histological hippocampal volume and degree of neuronal loss and AD pathology, and entorhinal cortical thickness change appears to be an early and sensitive indicator of neurodegeneration associated with AD.

    Time frame: Baseline (Day 1) and Week 48

  2. Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 48

    The ADCS-ADL inventory scale is validated questionnaire developed by the ADCS to assess instrumental and basic activities of daily living based on a 23-item structured interview of the AD study participant's partner. The scale ranging from 0 (none) to 78 (severe), with lower scores indicate greater impairment.

    Time frame: Baseline (Day 1) and Week 48

  3. Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 48

    The NPI is a well-validated, reliable, multi-item instrument to assess psychopathology in AD dementia based on the results of an interview with the study partner. The NPI evaluates both the frequency and severity of 10 neuropsychiatric features, including delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability and lability, and aberrant motor behavior, as well as evaluates sleep and appetite/eating disorders. Frequency assessments range from 1 (occasionally, less than once per week) to 4 (very frequently, once or more per day or continuously). Severity assessments range from 1 (mild) to 3 (severe). The total score is the sum of all subscales ranging from 1 (mild) to 7 (severe), with higher scores indicate greater impairment.

    Time frame: Baseline (Day 1) and Week 48

  4. Change From Baseline in Mini-Mental Status Examination (MMSE) Total Score at Week 48

    The MMSE is a frequently used screening instrument for AD drug studies. It evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy 2 intersecting pentagons. The MMSE scale ranging from 0 (worse) to 30 (best), with a lower score indicate more cognitive impairment.

    Time frame: Baseline (Day 1) and Week 48

  5. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

    An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the other serious outcomes. An AE is considered "Related" for causality designations of possible, probable and definite.

    Time frame: TEAEs were reported from first dose of study drug up to end of study treatment, maximum of 96 weeks.

Other outcomes

  1. Change From Baseline in Magnetic Resonance Imaging (MRI) Hippocampal Volume at Week 48 in Mild Subgroup

    Subgroup of participants MMSE Category = Mild. The MMSE scale ranging from 0 (worse) to 30 (best), with a lower score indicating more cognitive impairment. Mild are participants with a baseline MMSE score greater than or equal to 20.

    Time frame: Baseline (Day 1) and Week 48

07

Results

Posted Dec 6, 2023
Limitations and caveats
All participants in the OLE phase underwent a termination visit 2 weeks after the last dose of troriluzole.

Participant flow

This Phase 2, randomized, double-blind, placebo-controlled study was conducted in participants with mild to moderate alzheimer's disease (AD) at 44 centers in the US between 31-Jul-2018 and 23-Dec-2021.

Randomization Phase (Weeks 1 Through 48)
Participant flow — Randomization Phase (Weeks 1 Through 48)
MilestoneTroriluzolePlacebo
Started178172
Completed130133
Not completed4839
Withdrew: Withdrawal by subject1819
Withdrew: Adverse event143
Withdrew: Other14
Withdrew: Progressive disease32
Withdrew: Lack of efficacy22
Withdrew: Physician decision23
Withdrew: Non-compliance with study drug40
Withdrew: Protocol violation11
Withdrew: Lost to follow-up23
Withdrew: Death12
OLE Phase (48 Weeks)
Participant flow — OLE Phase (48 Weeks)
MilestoneTroriluzolePlacebo
Started90104
Completed3524
Not completed5580
Withdrew: Withdrawal by subject3051
Withdrew: Other68
Withdrew: Lack of efficacy65
Withdrew: Adverse event55
Withdrew: Progressive disease20
Withdrew: Physician decision57
Withdrew: Protocol violation01
Withdrew: Study terminated by sponsor01
Withdrew: Death02
Withdrew: Lost to follow-up10

Outcome measures

PrimaryChange From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score at Week 48

The ADAS-Cog is a structured scale that 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 were also obtained. The test was scored in terms of errors on a scale ranging from 0 (best) to 70 (worse), with higher scores indicate poorer performance and greater impairment.

Time frame:
Baseline (Day 1) and Week 48
Reported as:
Least squares mean · units on a scale
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score at Week 48
units on a scaleTroriluzolePlacebo
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score at Week 486.7 (5.3 to 8.1)6.7 (5.4 to 8.1)
Statistical analysis
  • Troriluzole vs Placebo · Mixed model with repeated measures · p = 0.9809 · Least square mean difference: 0.0 · 95% CI -1.8 to 1.8
PrimaryChange From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-Sum of Boxes) Total Score at Week 48

The CDR-sum of boxes is a validated composite rating of cognition and everyday functioning used in longitudinal AD research which incorporates both informant input and direct assessment of performance. It assesses through semi-structured interview 3 cognitive domains including memory, orientation, and judgement/problem solving and 3 everyday functional domains including community affairs, home and hobbies and personal care. The individual domain score ranging from 0 (none) to 3 (severe) but the scores in each of these were combined to obtain a composite score (sum of boxes) ranging from 0 (best) to 18 (worst), with higher scores indicate poorer performance and greater impairment. The individual domain scores are added to create a sum of the box scores.

Time frame:
Baseline (Day 1) and Week 48
Reported as:
Least squares mean · units on a scale
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-Sum of Boxes) Total Score at Week 48
units on a scaleTroriluzolePlacebo
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-Sum of Boxes) Total Score at Week 482.1 (1.7 to 2.5)1.9 (1.5 to 2.3)
Statistical analysis
  • Troriluzole vs Placebo · Mixed model with repeated measures · p = 0.4474 · Least square mean difference: -0.2 · 95% CI -0.8 to 0.3
SecondaryChange From Baseline in Magnetic Resonance Imaging (MRI) Hippocampal Volume at Week 48

Volumetric MRI allows the in vivo assessment of brain structure volume and provides a measure of atrophy rate. Results from MRI studies suggest that the patterns of atrophy in AD, which mirror the pathological progression of the disease, can reliably be detected and tracked across time. Hippocampal volume derived from MRI correlates with histological hippocampal volume and degree of neuronal loss and AD pathology, and entorhinal cortical thickness change appears to be an early and sensitive indicator of neurodegeneration associated with AD.

Time frame:
Baseline (Day 1) and Week 48
Reported as:
Least squares mean · percent deformation
Change From Baseline in Magnetic Resonance Imaging (MRI) Hippocampal Volume at Week 48
percent deformationTroriluzolePlacebo
Change From Baseline in Magnetic Resonance Imaging (MRI) Hippocampal Volume at Week 48-1.1 (-1.4 to -0.7)-1.1 (-1.5 to -0.8)
Statistical analysis
  • Troriluzole vs Placebo · ANCOVA · p = 0.8670 · Least square mean difference: 0.0 · 95% CI -0.6 to 0.5
SecondaryChange From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 48

The ADCS-ADL inventory scale is validated questionnaire developed by the ADCS to assess instrumental and basic activities of daily living based on a 23-item structured interview of the AD study participant's partner. The scale ranging from 0 (none) to 78 (severe), with lower scores indicate greater impairment.

Time frame:
Baseline (Day 1) and Week 48
Reported as:
Least squares mean · units on a scale
Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 48
units on a scaleTroriluzolePlacebo
Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 48-8.9 (-10.8 to -7.1)-7.4 (-9.2 to -5.6)
Statistical analysis
  • Troriluzole vs Placebo · Mixed model with repeated measures · p = 0.1950 · Least square mean difference: 1.6 · 95% CI -0.8 to 3.9
SecondaryChange From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 48

The NPI is a well-validated, reliable, multi-item instrument to assess psychopathology in AD dementia based on the results of an interview with the study partner. The NPI evaluates both the frequency and severity of 10 neuropsychiatric features, including delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability and lability, and aberrant motor behavior, as well as evaluates sleep and appetite/eating disorders. Frequency assessments range from 1 (occasionally, less than once per week) to 4 (very frequently, once or more per day or continuously). Severity assessments range from 1 (mild) to 3 (severe). The total score is the sum of all subscales ranging from 1 (mild) to 7 (severe), with higher scores indicate greater impairment.

Time frame:
Baseline (Day 1) and Week 48
Reported as:
Least squares mean · units on a scale
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 48
units on a scaleTroriluzolePlacebo
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 482.3 (0.2 to 4.4)3.8 (1.8 to 5.8)
Statistical analysis
  • Troriluzole vs Placebo · Mixed model with repeated measures · p = 0.2583 · Least square mean difference: 1.5 · 95% CI -1.1 to 4.1
SecondaryChange From Baseline in Mini-Mental Status Examination (MMSE) Total Score at Week 48

The MMSE is a frequently used screening instrument for AD drug studies. It evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy 2 intersecting pentagons. The MMSE scale ranging from 0 (worse) to 30 (best), with a lower score indicate more cognitive impairment.

Time frame:
Baseline (Day 1) and Week 48
Reported as:
Least squares mean · units on a scale
Change From Baseline in Mini-Mental Status Examination (MMSE) Total Score at Week 48
units on a scaleTroriluzolePlacebo
Change From Baseline in Mini-Mental Status Examination (MMSE) Total Score at Week 48-3.6 (-4.4 to -2.9)-3.2 (-4.0 to -2.5)
Statistical analysis
  • Troriluzole vs Placebo · Mixed model with repeated measures · p = 0.4191 · Least square mean difference: 0.4 · 95% CI -0.6 to 1.3
SecondaryNumber of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the other serious outcomes. An AE is considered "Related" for causality designations of possible, probable and definite.

Time frame:
TEAEs were reported from first dose of study drug up to end of study treatment, maximum of 96 weeks.
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
ParticipantsTroriluzole - Randomization PhasePlacebo - Randomization PhaseTroriluzole - Randomization Phase/ Troriluzole - OLE PhasePlacebo - Randomization Phase/ Troriluzole - OLE Phase
Any TEAEs1461165766
Any serious TEAEs2414916
Any fatal AE2202
Any serious TEAEs considered related3103
Drug withdrawn due to an TEAE163512
Other pre-specifiedChange From Baseline in Magnetic Resonance Imaging (MRI) Hippocampal Volume at Week 48 in Mild Subgroup

Subgroup of participants MMSE Category = Mild. The MMSE scale ranging from 0 (worse) to 30 (best), with a lower score indicating more cognitive impairment. Mild are participants with a baseline MMSE score greater than or equal to 20.

Time frame:
Baseline (Day 1) and Week 48
Reported as:
Least squares mean · percent deformation
Change From Baseline in Magnetic Resonance Imaging (MRI) Hippocampal Volume at Week 48 in Mild Subgroup
percent deformationTroriluzolePlacebo
Change From Baseline in Magnetic Resonance Imaging (MRI) Hippocampal Volume at Week 48 in Mild Subgroup-1.1 (-1.6 to -0.6)-1.6 (-2.1 to -1.0)
Statistical analysis
  • Troriluzole vs Placebo · ANCOVA · p = 0.2240 · Least square mean difference: -0.5 · 95% CI -1.2 to 0.3
Post-hocNumber of Responders in Participants With ADAS-cog Total Change and MRI Hippocampal Volume Change at Week 48 in Mild APOE e4 Carrier Subgroup

Mild APOE e4 carrier subgroup are participants with a baseline MMSE score greater than or equal to 20 with APOE e4 genotype. Responder based on ADAS-cog Total Change less than or equal to 1 and MRI Hippocampal Volume Change greater than or equal to -2.09. ADAS-cog change and MRI Hippcampal volume change criteria based on 25th percentile.

Time frame:
Baseline (Day 1) and Week 48
Reported as:
Count of participants · Participants
Number of Responders in Participants With ADAS-cog Total Change and MRI Hippocampal Volume Change at Week 48 in Mild APOE e4 Carrier Subgroup
ParticipantsTroriluzolePlacebo
Number of Responders in Participants With ADAS-cog Total Change and MRI Hippocampal Volume Change at Week 48 in Mild APOE e4 Carrier Subgroup144
Statistical analysis
  • Troriluzole vs Placebo · Fisher Exact · p = 0.0161

Adverse events

Collected over TEAEs were reported from first dose of study drug up to end of study treatment, maximum of 96 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Troriluzole - Randomization Phase2/178 (1.1%)24/178 (13.5%)81/178 (45.5%)
Placebo - Randomization Phase2/171 (1.2%)14/171 (8.2%)53/171 (31%)
Troriluzole - Randomization Phase/ Troriluzole - OLE Phase0/90 (0%)9/90 (10%)29/90 (32.2%)
Placebo - Randomization Phase/ Troriluzole - OLE Phase2/103 (1.9%)16/103 (15.5%)31/103 (30.1%)
Most frequent serious events
Showing 10 of 63
Most frequent serious events
EventTroriluzole - Randomization PhasePlacebo - Randomization PhaseTroriluzole - Randomization Phase/ Troriluzole - OLE PhasePlacebo - Randomization Phase/ Troriluzole - OLE Phase
FallInjury, poisoning and procedural complications0/1781/1712/900/103
AnaemiaBlood and lymphatic system disorders0/1780/1710/902/103
Pulmonary embolismRespiratory, thoracic and mediastinal disorders3/1780/1710/902/103
Urinary tract infectionInfections and infestations2/1782/1711/901/103
SyncopeNervous system disorders0/1782/1710/901/103
DiarrhoeaGastrointestinal disorders2/1780/1710/900/103
DiverticulitisInfections and infestations2/1780/1710/900/103
Hip fractureInjury, poisoning and procedural complications2/1781/1711/900/103
FaecalomaGastrointestinal disorders0/1780/1711/900/103
Colonic abscessInfections and infestations1/1780/1711/900/103
Most frequent other events
Showing 10 of 11
Most frequent other events
EventTroriluzole - Randomization PhasePlacebo - Randomization PhaseTroriluzole - Randomization Phase/ Troriluzole - OLE PhasePlacebo - Randomization Phase/ Troriluzole - OLE Phase
FallInjury, poisoning and procedural complications19/17811/17110/907/103
Weight decreasedInvestigations16/1784/1710/902/103
Decreased appetiteMetabolism and nutrition disorders16/1782/1711/901/103
DiarrhoeaGastrointestinal disorders15/1786/1711/903/103
Urinary tract infectionInfections and infestations15/17812/1715/905/103
HeadacheNervous system disorders6/17814/1713/903/103
DizzinessNervous system disorders10/17813/1713/902/103
Liver function test increasedInvestigations5/1780/1712/906/103
Coronavirus infectionInfections and infestations0/1780/1715/901/103
Oedema peripheralGeneral disorders9/1782/1710/900/103

Baseline characteristics

Treated population included enrolled and randomized participants who received at least 1 dose of blinded study therapy (troriluzole or placebo).

Age, Continuous
Age, Continuous(years)TroriluzolePlaceboTotal
Mean71.8 ± 7.9371.6 ± 7.9171.7 ± 7.91
Sex: Female, Male
Sex: Female, Male(Participants)TroriluzolePlaceboTotal
Female11092202
Male6879147
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)TroriluzolePlaceboTotal
Hispanic or Latino459
Not Hispanic or Latino172165337
Unknown or Not Reported213
Race (NIH/OMB)
Race (NIH/OMB)(Participants)TroriluzolePlaceboTotal
American Indian or Alaska Native000
Asian246
Native Hawaiian or Other Pacific Islander101
Black or African American549
White170163333
More than one race000
Unknown or Not Reported000
08

Study locations

44 sites
  • Xenoscience, Inc.
    Phoenix, Arizona 85004, United States
  • Barrow Neurological Institute
    Phoenix, Arizona 85013, United States
  • Banner Sun Health Research Institute
    Sun City, Arizona 85351, United States
  • Neurology Center of North Orange County
    Fullerton, California 92835, United States
  • University of California, San Diego
    La Jolla, California 92037, United States
  • University of Southern California
    Los Angeles, California 90033, United States
  • SC3 Research Group - Pasadena
    Pasadena, California 91105, United States
  • Geriatric and Adult Psychiatry
    Hamden, Connecticut 06518, United States
  • Yale University School of Medicine
    New Haven, Connecticut 06510, United States
  • Ki Health PARTNERS LLC DBA NEW ENGLAND INSTITUTE FOR CLINICAL RESEARCH
    Stamford, Connecticut 06905, United States
  • Brain Matters Research
    Delray Beach, Florida 33445, United States
  • University of Miami
    Miami, Florida 33136, United States
  • USF Health Byrd Alzheimer's Institute
    Tampa, Florida 33613, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Great Lakes Clinical Trials
    Chicago, Illinois 60640, United States
  • Southern Illinois University
    Springfield, Illinois 62702, United States
  • Indiana University
    Indianapolis, Indiana 46202, United States
  • University of Iowa
    Iowa City, Iowa 52242, United States
  • University of Kentucky
    Lexington, Kentucky 40504, United States
  • Pennington Biomedical Research Center
    Baton Rouge, Louisiana 70808, United States
  • Northern Light Acadia Hospital
    Bangor, Maine 04401, United States
  • Johns Hopkins University
    Baltimore, Maryland 21224, United States
  • University of Michigan, Ann Arbor
    Ann Arbor, Michigan 48105, United States
  • Michigan State University
    East Lansing, Michigan 48824, United States
  • Galen Research
    Chesterfield, Missouri 63005, United States
  • Cleveland Clinic Lou Ruvo Center
    Las Vegas, Nevada 89106, United States
  • Princeton Medical Institute
    Princeton, New Jersey 08540, United States
  • James J. Peters VAMC
    Bronx, New York 10468, United States
  • Columbia University
    New York, New York 10032, United States
  • University of Rochester Medical Center
    Rochester, New York 14620, United States
  • SUNY Upstate Medical University Department of Geriatrics
    Syracuse, New York 13202, United States
  • Case Western Reserve University
    Beachwood, Ohio 44122, United States
  • Ohio State University
    Columbus, Ohio 43210, United States
  • Tulsa Clinical Research
    Tulsa, Oklahoma 74104, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
  • Keystone Clinical Studies, LLC
    Norristown, Pennsylvania 19403, United States
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
  • Geisinger Medical Clinic
    Wilkes-Barre, Pennsylvania 18711, United States
  • Abington Neurological Associates
    Willow Grove, Pennsylvania 19090, United States
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
  • CBRI, Roper Hospital
    Charleston, South Carolina 29401, United States
  • Vanderbilt Memory & Alzheimer's Center
    Nashville, Tennessee 37212, United States
  • The Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases,University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229-3900, United States
  • University of Washington
    Seattle, Washington 98108, United States
09

References and documents

Study documents

  • Study protocol · Sep 12, 2020
  • Statistical analysis plan · Dec 3, 2020

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03605667
Lead sponsor
Biohaven Pharmaceuticals, Inc.
Collaborators
Alzheimer's Disease Cooperative Study (ADCS)
Responsible party
Sponsor
First posted
Jul 30, 2018
Start date
Jul 31, 2018
Primary completion
Dec 15, 2020
Completion
Dec 23, 2021
Results posted
Dec 6, 2023
Last update
Dec 6, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Alzheimer Disease→

Other studies from this sponsor

Biohaven Pharmaceuticals, Inc.

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