Feru-guard for Behavioral Symptoms in Dementia

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glovia Co., Ltd.
• Collaborator: Oregon Health and Science University
• Treatments: Ferulic acid

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.