Feru-guard (Ferulic Acid and Angelica Archangelica Extract) for Behavioral Symptoms in Dementia
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 主要终点
- Change from Baseline Neuropsychiatric Inventory Questionnaire at 12 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind, placebo-controlled study. The placebos will be matched to the active supplement in both sensory and physical characteristics. The participants, study investigators, research associates, and study coordinators will have no knowledge of study assignment. Data analysis will be performed blinded to treatment status. The OHSU Research Pharmacy will be responsible for establishing a randomization scheme for newly enrolled participants. Additionally, the Research Pharmacy will ensure blinding of all study medications. The investigators will also evaluate the effectiveness of our blinding by giving study evaluators, participants, study partners, and investigators a short questionnaire asking about knowledge of group assignment. The randomization code will be broken only after data analysis or if there are numerous serious adverse events before the end of the study.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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:
- •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 >
- •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.
研究组 & 干预措施
Feru-guard
Over a 12 week period participants will take two 280 mg hard gel capsules of Feru-guard 100M per day (1 capsule am, 1 capsule pm). One capsule will be taken in the morning with a meal and one capsule will be taken in the afternoon with a meal. Each capsule contains 180.32 mg ferulic acid and 20.02 mg of Angelica archangelica. Total daily dose will be 560mg of Feru-guard 100M, with 360.64 mg of ferulic acid and 40.04 mg of Angelica archangelica.
干预措施: Feru-guard 100M (Drug)
Placebo
Over a 12 week period participants will take two 280 mg hard gel capsules of a placebo per day (1 capsule am, 1 capsule pm). One capsule will be taken in the morning with a meal and one capsule will be taken in the afternoon with a meal.Total daily dosage will be 560mg of a maltodextrin, calcium stearate, and vanilla food flavor mixture.
干预措施: Feru-guard 100M Placebo (Other)
结局指标
主要结局
Change from Baseline Neuropsychiatric Inventory Questionnaire at 12 weeks
时间窗: Administered 2 times 1 baseline, then 12 weeks later.
The NPI-Q is a structured interview with a caregiver or qualified study partner (defined as having direct contact \> 2 days/week) that evaluates both presence and severity of 12 neuropsychiatric features which include: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability, lability, apathy, aberrant motor behavior, night-time behavior, and appetite/ eating changes. If the response to the domain question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale ranging from 1 to 3 (mild to severe). Change in overall NPI-Q score between baseline and at 12 weeks will be the primary outcome measure.
次要结局
- Change from Baseline Neuropsychiatric Inventory Questionnaire subscale of caregiver distress at 12 weeks(Administered 2 times 1 baseline, then 12 weeks later.)
- Change from Baseline Zarit Burden Interview Screening Version at 12 weeks(Administered 2 times 1 baseline, then 12 weeks later.)
- Change from Baseline Short Form Health Survey 12-Item at 12 weeks(Administered 2 times 1 baseline, then 12 weeks later.)