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Feru-guard for Behavioral Symptoms in Dementia

Primary Purpose

Behavioral and Psychiatric Symptoms of Dementia

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Feru-guard 100M
Feru-guard 100M Placebo
Sponsored by
Glovia Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behavioral and Psychiatric Symptoms of Dementia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 55 years old or older.
  • Diagnosis of AD, vascular, and mixed dementia
  • Neuropsychiatric Inventory Questionnaire (NPI-Q) at least 3 items out of 12 items are rated as "present."
  • Use of cholinesterase inhibitors, antidepressants and or antipsychotics medications is allowed, if on stable dosage for at least 2 months.
  • Use of memantine and/or serotonin reuptake inhibitors is also allowed, if on stable dose for at least 2 months.
  • Have a committed caregiver who is able and willing to assist them with medications, provide study participant information, and attend all study visits.
  • Sufficient English language skills to complete all testing.
  • MMSE score of 25 or lower.

Exclusion Criteria:

  • Participants who started using antipsychotics or anticholinergics within the previous 2 months.
  • Participants on blood thinners such as warfarin (Coumadin, jantoven), rivaroxaban (xarelto), fondaparinux (arixtra), dibigatran (pradaxa), apixaban (eliquis) dalteparin (fragmin), enoxaparin (lovenox). Aspirin use is allowed.
  • Participants without an identified caregiver.
  • Participants with delirium caused by medicinal poisoning or drug intoxication.

  • Participants who have had the following diseases before the onset of cognitive impairment:

    1. Alcoholism
    2. Manic depression or bipolar disorder
    3. Schizophrenia
  • Participants with malignancy or an acute inflammatory disease.
  • Participants with critical circulatory, respiratory, kidney, or liver disease or diabetes.
  • BMI of >30.
  • Participants who have taken Feru-guard, ferulic acid, or Angelica archangelica supplementation within the last year.
  • Enrollment in another clinical trial or treatment study within the previous 6 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Feru-guard

    Placebo

    Arm Description

    Over a 12 week period participants will take two 280 mg hard gel capsules of Feru-guard 100M per day (1 capsule am, 1 capsule pm). One capsule will be taken in the morning with a meal and one capsule will be taken in the afternoon with a meal. Each capsule contains 180.32 mg ferulic acid and 20.02 mg of Angelica archangelica. Total daily dose will be 560mg of Feru-guard 100M, with 360.64 mg of ferulic acid and 40.04 mg of Angelica archangelica.

    Over a 12 week period participants will take two 280 mg hard gel capsules of a placebo per day (1 capsule am, 1 capsule pm). One capsule will be taken in the morning with a meal and one capsule will be taken in the afternoon with a meal.Total daily dosage will be 560mg of a maltodextrin, calcium stearate, and vanilla food flavor mixture.

    Outcomes

    Primary Outcome Measures

    Change from Baseline Neuropsychiatric Inventory Questionnaire at 12 weeks
    The NPI-Q is a structured interview with a caregiver or qualified study partner (defined as having direct contact > 2 days/week) that evaluates both presence and severity of 12 neuropsychiatric features which include: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability, lability, apathy, aberrant motor behavior, night-time behavior, and appetite/ eating changes. If the response to the domain question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale ranging from 1 to 3 (mild to severe). Change in overall NPI-Q score between baseline and at 12 weeks will be the primary outcome measure.

    Secondary Outcome Measures

    Change from Baseline Neuropsychiatric Inventory Questionnaire subscale of caregiver distress at 12 weeks
    The NPI-Q is a structured interview with a caregiver or qualified study partner (defined as having direct contact > 2 days/week) that evaluates both presence and severity of 12 neuropsychiatric features which include: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability, lability, apathy, aberrant motor behavior, night-time behavior, and appetite/ eating changes. A modification of the original NPI is the addition of a Caregiver Distress Scale for evaluating the psychological impact of neuropsychiatric symptoms reported to be present. For each feature the caregiver distress score ranges from 1-5 (No distress to extreme distress). The caregiver distress subscale score is the sum of the distress scores for each of the 12 features. Change in overall NPI-Q subscale of caregiver distress score which is the between baseline and at 12 weeks will be a secondary outcome measure.
    Change from Baseline Zarit Burden Interview Screening Version at 12 weeks
    The Zarit Burden Interview (ZBI) Screening Version is a popular caregiver self-report measure used by many aging agencies, and originated as a 29-item questionnaire. The revised screening version contains 4 items and has been validated. Each item on the interview is a statement which the caregiver is asked to endorse using a 4-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Change in overall ZBI score between baseline and at 12 weeks will be a secondary outcome measure.
    Change from Baseline Short Form Health Survey 12-Item at 12 weeks
    The 12-Item Short Form Health Survey (SF-12) is a 12-item validated shortened version of the SF-36 and was designed to provide a health-related quality of life (HRQL) measure that was quick and easy to administer in large population studies. The SF-12 contains a subset of the 12 items from the SF-36 and information from this subset of questions is used to construct a physical and mental component summary score (PCS and MCS, respectively). Change in overall SF-12 score between baseline and at 12 weeks will be a secondary outcome measure.

    Full Information

    First Posted
    February 14, 2018
    Last Updated
    August 1, 2018
    Sponsor
    Glovia Co., Ltd.
    Collaborators
    Oregon Health and Science University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03451760
    Brief Title
    Feru-guard for Behavioral Symptoms in Dementia
    Official Title
    Feru-guard (Ferulic Acid and Angelica Archangelica Extract) for Behavioral Symptoms in Dementia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2018 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Glovia Co., Ltd.
    Collaborators
    Oregon Health and Science University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is designed as a randomized, double-blind, placebo-controlled clinical trial with a 12 week intervention period. Seventy participants with a diagnosis of AD, vascular, and mixed dementia with at least 3 behavioral symptoms present from the Neuropsychiatric Inventory Questionnaires (NPI-Q) will be randomized to the Feru-guard (ferulic acid and Angelica archangelica) or placebo group. Participants will be screened first by a telephone interview or briefly in-clinic and then will be scheduled for an in-clinic screen to establish study eligibility prior to the baseline assessment visit. Clinical and biological outcome measures will occur at baseline and 12 weeks.
    Detailed Description
    The participants will be assessed for eligibility using the NPI-Q and must have at least 3 symptoms present, and a score of 25 or lower on the Mini Mental State Exam (MMSE). Participants will also be screened for a previous diagnosis of either Vascular Dementia, Alzheimer's disease, or Mixed Dementia using DSM-5 criteria. The primary outcome measure will be a change in the total score of Neuropsychiatric Inventory Questionnaire (NPI-Q) over 12-weeks. The investigators expect the group receiving Feru-guard will have a greater improvement in total NPI score compared to the placebo group at 12-weeks. The investigators will also collect data on the effect of Feru-guard supplementation on care-giver burden using the NPI-Q subscale of caregiver distress, Zarit Burden Interview (ZBI) screening version, and quality of life (SF-12) over 12 weeks. The investigators will also collect data on changes in global cognition of participants over 12 weeks using the Montreal Cognitive Assessment (MoCA). The investigators will compare secondary outcomes between Feru-guard and control group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Behavioral and Psychiatric Symptoms of Dementia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized, double-blind, placebo-controlled clinical trial with a 12 week intervention period.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    This is a double-blind, placebo-controlled study. The placebos will be matched to the active supplement in both sensory and physical characteristics. The participants, study investigators, research associates, and study coordinators will have no knowledge of study assignment. Data analysis will be performed blinded to treatment status. The OHSU Research Pharmacy will be responsible for establishing a randomization scheme for newly enrolled participants. Additionally, the Research Pharmacy will ensure blinding of all study medications. The investigators will also evaluate the effectiveness of our blinding by giving study evaluators, participants, study partners, and investigators a short questionnaire asking about knowledge of group assignment. The randomization code will be broken only after data analysis or if there are numerous serious adverse events before the end of the study.
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Feru-guard
    Arm Type
    Experimental
    Arm Description
    Over a 12 week period participants will take two 280 mg hard gel capsules of Feru-guard 100M per day (1 capsule am, 1 capsule pm). One capsule will be taken in the morning with a meal and one capsule will be taken in the afternoon with a meal. Each capsule contains 180.32 mg ferulic acid and 20.02 mg of Angelica archangelica. Total daily dose will be 560mg of Feru-guard 100M, with 360.64 mg of ferulic acid and 40.04 mg of Angelica archangelica.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Over a 12 week period participants will take two 280 mg hard gel capsules of a placebo per day (1 capsule am, 1 capsule pm). One capsule will be taken in the morning with a meal and one capsule will be taken in the afternoon with a meal.Total daily dosage will be 560mg of a maltodextrin, calcium stearate, and vanilla food flavor mixture.
    Intervention Type
    Drug
    Intervention Name(s)
    Feru-guard 100M
    Intervention Description
    Feru-guard is a dietary supplement commercially available in Japan in the form of a 1.5 g instant powder packet that is sold in health clinics and directly by Glovia Co. Ltd to patients on doctor's recommendation. The current study will use Feru-guard in the form of a 280 mg hard gel capsule that contains the same amount of the active ingredients (ferulic acid and Angelica archangelica) as the 1.5 g packets. In order to conduct a double-blind, placebo-controlled trial, Feru-guard is contained in opaque, hard gel capsules which allows for better matching of characteristics and improved blinding than studies using powder. Feru-guard will be supplied by Glovia, Co. Ltd., in Tokyo, Japan.
    Intervention Type
    Other
    Intervention Name(s)
    Feru-guard 100M Placebo
    Other Intervention Name(s)
    Placebo
    Intervention Description
    In order to conduct a double-blind, controlled trial, the placebo will be contained in opaque, hard gel capsules which allows for better matching of characteristics and improved blinding. The placebo study drug will be matched to the Feru-guard 100M in terms of appearance, smell, and taste.
    Primary Outcome Measure Information:
    Title
    Change from Baseline Neuropsychiatric Inventory Questionnaire at 12 weeks
    Description
    The NPI-Q is a structured interview with a caregiver or qualified study partner (defined as having direct contact > 2 days/week) that evaluates both presence and severity of 12 neuropsychiatric features which include: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability, lability, apathy, aberrant motor behavior, night-time behavior, and appetite/ eating changes. If the response to the domain question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale ranging from 1 to 3 (mild to severe). Change in overall NPI-Q score between baseline and at 12 weeks will be the primary outcome measure.
    Time Frame
    Administered 2 times 1 baseline, then 12 weeks later.
    Secondary Outcome Measure Information:
    Title
    Change from Baseline Neuropsychiatric Inventory Questionnaire subscale of caregiver distress at 12 weeks
    Description
    The NPI-Q is a structured interview with a caregiver or qualified study partner (defined as having direct contact > 2 days/week) that evaluates both presence and severity of 12 neuropsychiatric features which include: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability, lability, apathy, aberrant motor behavior, night-time behavior, and appetite/ eating changes. A modification of the original NPI is the addition of a Caregiver Distress Scale for evaluating the psychological impact of neuropsychiatric symptoms reported to be present. For each feature the caregiver distress score ranges from 1-5 (No distress to extreme distress). The caregiver distress subscale score is the sum of the distress scores for each of the 12 features. Change in overall NPI-Q subscale of caregiver distress score which is the between baseline and at 12 weeks will be a secondary outcome measure.
    Time Frame
    Administered 2 times 1 baseline, then 12 weeks later.
    Title
    Change from Baseline Zarit Burden Interview Screening Version at 12 weeks
    Description
    The Zarit Burden Interview (ZBI) Screening Version is a popular caregiver self-report measure used by many aging agencies, and originated as a 29-item questionnaire. The revised screening version contains 4 items and has been validated. Each item on the interview is a statement which the caregiver is asked to endorse using a 4-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Change in overall ZBI score between baseline and at 12 weeks will be a secondary outcome measure.
    Time Frame
    Administered 2 times 1 baseline, then 12 weeks later.
    Title
    Change from Baseline Short Form Health Survey 12-Item at 12 weeks
    Description
    The 12-Item Short Form Health Survey (SF-12) is a 12-item validated shortened version of the SF-36 and was designed to provide a health-related quality of life (HRQL) measure that was quick and easy to administer in large population studies. The SF-12 contains a subset of the 12 items from the SF-36 and information from this subset of questions is used to construct a physical and mental component summary score (PCS and MCS, respectively). Change in overall SF-12 score between baseline and at 12 weeks will be a secondary outcome measure.
    Time Frame
    Administered 2 times 1 baseline, then 12 weeks later.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 55 years old or older. Diagnosis of AD, vascular, and mixed dementia Neuropsychiatric Inventory Questionnaire (NPI-Q) at least 3 items out of 12 items are rated as "present." Use of cholinesterase inhibitors, antidepressants and or antipsychotics medications is allowed, if on stable dosage for at least 2 months. Use of memantine and/or serotonin reuptake inhibitors is also allowed, if on stable dose for at least 2 months. Have a committed caregiver who is able and willing to assist them with medications, provide study participant information, and attend all study visits. Sufficient English language skills to complete all testing. MMSE score of 25 or lower. Exclusion Criteria: Participants who started using antipsychotics or anticholinergics within the previous 2 months. Participants on blood thinners such as warfarin (Coumadin, jantoven), rivaroxaban (xarelto), fondaparinux (arixtra), dibigatran (pradaxa), apixaban (eliquis) dalteparin (fragmin), enoxaparin (lovenox). Aspirin use is allowed. Participants without an identified caregiver. Participants with delirium caused by medicinal poisoning or drug intoxication. Participants who have had the following diseases before the onset of cognitive impairment: Alcoholism Manic depression or bipolar disorder Schizophrenia Participants with malignancy or an acute inflammatory disease. Participants with critical circulatory, respiratory, kidney, or liver disease or diabetes. BMI of >30. Participants who have taken Feru-guard, ferulic acid, or Angelica archangelica supplementation within the last year. Enrollment in another clinical trial or treatment study within the previous 6 months.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jason R David, B.A.
    Phone
    5034949240
    Email
    dajaso@ohsu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lynne Shinto, N.D., M.P.H.
    Organizational Affiliation
    Oregon Health and Science University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sarah Goodlin, M.D.
    Organizational Affiliation
    Portland VA, Oregon Health and Science University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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