Behavioral and Psychiatric Symptoms of Dementia Clinical Trial
Official title:
Feru-guard (Ferulic Acid and Angelica Archangelica Extract) for Behavioral Symptoms in Dementia
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.
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.
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