Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:36 AM
Study NCT ID:
NCT03451760
Status:
UNKNOWN
Last Update Posted:
2018-08-03
First Post:
2018-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feru-guard for Behavioral Symptoms in Dementia
Sponsor:
Glovia Co., Ltd.
Organization:
Study Overview
Official Title:
Feru-guard (Ferulic Acid and Angelica Archangelica Extract) for Behavioral Symptoms in Dementia
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: