Status:
UNKNOWN
Feru-guard for Behavioral Symptoms in Dementia
Lead Sponsor:
Glovia Co., Ltd.
Collaborating Sponsors:
Oregon Health and Science University
Conditions:
Behavioral and Psychiatric Symptoms of Dementia
Eligibility:
All Genders
55+ years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03451760
Start Date
September 1 2018
End Date
December 1 2019
Last Update
August 3 2018
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