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NCT03451760
Feru-guard (Ferulic Acid and Angelica Archangelica Extract) for Behavioral Symptoms in Dementia
Phase 2 trial testing Feru-guard 100M in Behavioral and Psychiatric Symptoms of Dementia in 70 participants. Status unknown.
1 December 2019
Quick facts
| Lead sponsor | Glovia Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 1 September 2018 |
| Primary completion | 1 December 2019 |
| Estimated completion | 1 December 2019 |
Drugs / interventions tested
- Feru-guard 100M — full drug profile →
- Feru-guard 100M Placebo
Conditions studied
- Behavioral and Psychiatric Symptoms of Dementia — all drugs for Behavioral and Psychiatric Symptoms of Dementia →
Sponsor
Glovia Co., Ltd. — full company profile →
Who can join
55 and older, any sex, with Behavioral and Psychiatric Symptoms of Dementia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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 appet
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03451760
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other recruiting trials for Behavioral and Psychiatric Symptoms of Dementia
Currently open trials in the same condition.
- NCT07364825 — Acute Psychiatric Care at Home for Lower-risk Patients With Acute Psychiatric Illness Who Require Inpatient Care · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03451760 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Glovia Co., Ltd.
- Last refreshed: 1 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03451760.
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