Feru-guard for Behavioral Symptoms in Dementia
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|ClinicalTrials.gov Identifier: NCT03451760|
Recruitment Status : Not yet recruiting
First Posted : March 2, 2018
Last Update Posted : August 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Behavioral and Psychiatric Symptoms of Dementia||Drug: Feru-guard 100M Other: Feru-guard 100M Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, double-blind, placebo-controlled clinical trial with a 12 week intervention period.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||Feru-guard (Ferulic Acid and Angelica Archangelica Extract) for Behavioral Symptoms in Dementia|
|Estimated Study Start Date :||September 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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.
Drug: Feru-guard 100M
Feru-guard is a dietary supplement commercially available in Japan in the form of a 1.5 g instant powder packet that is sold in health clinics and directly by Glovia Co. Ltd to patients on doctor's recommendation. The current study will use Feru-guard in the form of a 280 mg hard gel capsule that contains the same amount of the active ingredients (ferulic acid and Angelica archangelica) as the 1.5 g packets. In order to conduct a double-blind, placebo-controlled trial, Feru-guard is contained in opaque, hard gel capsules which allows for better matching of characteristics and improved blinding than studies using powder. Feru-guard will be supplied by Glovia, Co. Ltd., in Tokyo, Japan.
Placebo Comparator: 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.
Other: Feru-guard 100M Placebo
In order to conduct a double-blind, controlled trial, the placebo will be contained in opaque, hard gel capsules which allows for better matching of characteristics and improved blinding. The placebo study drug will be matched to the Feru-guard 100M in terms of appearance, smell, and taste.
Other Name: Placebo
- Change from Baseline Neuropsychiatric Inventory Questionnaire at 12 weeks [ Time Frame: 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.
- Change from Baseline Neuropsychiatric Inventory Questionnaire subscale of caregiver distress at 12 weeks [ Time Frame: 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. A modification of the original NPI is the addition of a Caregiver Distress Scale for evaluating the psychological impact of neuropsychiatric symptoms reported to be present. For each feature the caregiver distress score ranges from 1-5 (No distress to extreme distress). The caregiver distress subscale score is the sum of the distress scores for each of the 12 features. Change in overall NPI-Q subscale of caregiver distress score which is the between baseline and at 12 weeks will be a secondary outcome measure.
- Change from Baseline Zarit Burden Interview Screening Version at 12 weeks [ Time Frame: Administered 2 times 1 baseline, then 12 weeks later. ]The Zarit Burden Interview (ZBI) Screening Version is a popular caregiver self-report measure used by many aging agencies, and originated as a 29-item questionnaire. The revised screening version contains 4 items and has been validated. Each item on the interview is a statement which the caregiver is asked to endorse using a 4-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Change in overall ZBI score between baseline and at 12 weeks will be a secondary outcome measure.
- Change from Baseline Short Form Health Survey 12-Item at 12 weeks [ Time Frame: Administered 2 times 1 baseline, then 12 weeks later. ]The 12-Item Short Form Health Survey (SF-12) is a 12-item validated shortened version of the SF-36 and was designed to provide a health-related quality of life (HRQL) measure that was quick and easy to administer in large population studies. The SF-12 contains a subset of the 12 items from the SF-36 and information from this subset of questions is used to construct a physical and mental component summary score (PCS and MCS, respectively). Change in overall SF-12 score between baseline and at 12 weeks will be a secondary outcome measure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451760
|Contact: Jason R David, B.A.||firstname.lastname@example.org|
|Principal Investigator:||Lynne Shinto, N.D., M.P.H.||Oregon Health and Science University|
|Principal Investigator:||Sarah Goodlin, M.D.||Portland VA, Oregon Health and Science University|