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Feru-guard for Behavioral Symptoms in Dementia

NCT03451760 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-08-03

No results posted yet for this study

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.

Conditions

  • Behavioral and Psychiatric Symptoms of Dementia

Interventions

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.

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.

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • Glovia Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lynne Shinto, N.D., M.P.H. · Oregon Health and Science University

  • Sarah Goodlin, M.D. · Portland VA, Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2019-12-31
Completion
2019-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03451760 on ClinicalTrials.gov