Clinical trial NCT03451760: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Behavioral and Psychiatric Symptoms of Dementia
Lead sponsor: Glovia Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Oregon Health and Science University
First posted: 2018-03-02
Enrollment: 70
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled clinical trial with a 12 week intervention period.
Primary purpose: TREATMENT

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.

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:

  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.

Primary outcomes:
measure: Change from Baseline Neuropsychiatric Inventory Questionnaire at 12 weeks
timeFrame: Administered 2 times 1 baseline, then 12 weeks later.
Secondary outcomes:
measure: Change from Baseline Neuropsychiatric Inventory Questionnaire subscale of caregiver distress at 12 weeks
timeFrame: Administered 2 times 1 baseline, then 12 weeks later.
measure: Change from Baseline Zarit Burden Interview Screening Version at 12 weeks
timeFrame: Administered 2 times 1 baseline, then 12 weeks later.
measure: Change from Baseline Short Form Health Survey 12-Item at 12 weeks
timeFrame: Administered 2 times 1 baseline, then 12 weeks later.
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health and Science University
name: Lynne Shinto, N.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
affiliation: Portland VA, Oregon Health and Science University
name: Sarah Goodlin, M.D.
role: PRINCIPAL_INVESTIGATOR
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