Behavioral and Psychiatric Symptoms of DementiaPhase 2NCT03451760

Feru-guard for Behavioral Symptoms in Dementia

A Phase 2 study testing Feru-guard 100M in people with Behavioral and Psychiatric Symptoms of Dementia, run by Glovia Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 55 years and older
Conditions the study is for: Behavioral and Psychiatric Symptoms of Dementia
What is being tested?: Feru-guard 100M
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: No sites listed yet
Study dates: Sep 2018to Dec 2019
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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:
Alcoholism

Show all 13Show fewer

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 >30.
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.

Trial locations and contacts

No sites are listed yet.

Jason R David, B.A. contact

5034949240

dajaso@ohsu.edu

About this study

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.

Read the detailed description

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.

Conditions: Behavioral and Psychiatric Symptoms of Dementia
Being tested: Feru-guard 100M, Feru-guard 100M Placebo
Medical subject headings: Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Feru-guard 100MDrug
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.
Feru-guard 100M PlaceboOther
Also called 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.

Study groups in NCT03451760
Study group	Role	What they receive
Feru-guard	Experimental	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. Receives: Drug: Feru-guard 100M
Placebo	Placebo comparator	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. Receives: Other: Feru-guard 100M Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline Neuropsychiatric Inventory Questionnaire at 12 weeks
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.
Measured: Administered 2 times 1 baseline, then 12 weeks later.

Secondary outcomes (3)

Change from Baseline Neuropsychiatric Inventory Questionnaire subscale of caregiver distress at 12 weeks
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.
Measured: Administered 2 times 1 baseline, then 12 weeks later.
Change from Baseline Zarit Burden Interview Screening Version at 12 weeks
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.
Measured: Administered 2 times 1 baseline, then 12 weeks later.
Change from Baseline Short Form Health Survey 12-Item at 12 weeks
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.
Measured: Administered 2 times 1 baseline, then 12 weeks later.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2018Dec 2019

First posted2 Mar 2018
Study startSep 2018 (estimated)
Primary completionDec 2019 (estimated)
Study completionDec 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (60)Papers the sponsor has linked to this study.
Other trials for Behavioral and Psychiatric Symptoms of DementiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, double-blind, placebo-controlled clinical trial with a 12 week intervention period.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03451760
Sponsor's protocol ID: 17966
Status last verified: Aug 2018
First submitted: 14 Feb 2018
Last updated: 3 Aug 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Hersch EC, Falzgraf S. Management of the behavioral and psychological symptoms of dementia. Clin Interv Aging. 2007;2(4):611-21. doi: 10.2147/cia.s1698.
PubMed 18225462
de Oliveira AM, Radanovic M, de Mello PC, Buchain PC, Vizzotto AD, Celestino DL, Stella F, Piersol CV, Forlenza OV. Nonpharmacological Interventions to Reduce Behavioral and Psychological Symptoms of Dementia: A Systematic Review. Biomed Res Int. 2015;2015:218980. doi: 10.1155/2015/218980. Epub 2015 Nov 29.
PubMed 26693477
Dorey JM, Beauchet O, Thomas Anterion C, Rouch I, Krolak-Salmon P, Gaucher J, Gonthier R, Akiskal HS. Behavioral and psychological symptoms of dementia and bipolar spectrum disorders: review of the evidence of a relationship and treatment implications. CNS Spectr. 2008 Sep;13(9):796-803. doi: 10.1017/s1092852900013924.
PubMed 18849899
Adams BE, Tunis SL, Edell WS. Assessing antipsychotic effectiveness in dementia with the factor structure of the Psychogeriatric Dependency Rating Scale (PGDRS). J Am Med Dir Assoc. 2003 Mar-Apr;4(2):61-6. doi: 10.1097/01.JAM.0000052521.47659.7E.
PubMed 12807576
Herrmann N. Recommendations for the management of behavioral and psychological symptoms of dementia. Can J Neurol Sci. 2001 Feb;28 Suppl 1:S96-107. doi: 10.1017/s0317167100001268.
PubMed 11237317
Kar N. Behavioural and Psychological Symptoms of Dementia. In: Kar N, Jolley D, Misra N, editors. Handbook of Dementia. Hyderabad: Paras Medical Publisher; 2005. pp. 54-74.
Wynn ZJ, Cummings JL. Cholinesterase inhibitor therapies and neuropsychiatric manifestations of Alzheimer's disease. Dement Geriatr Cogn Disord. 2004;17(1-2):100-8. doi: 10.1159/000074281. Epub 2003 Oct 15.
PubMed 14564129
Mori T, Koyama N, Guillot-Sestier MV, Tan J, Town T. Ferulic acid is a nutraceutical beta-secretase modulator that improves behavioral impairment and alzheimer-like pathology in transgenic mice. PLoS One. 2013;8(2):e55774. doi: 10.1371/journal.pone.0055774. Epub 2013 Feb 8.
PubMed 23409038
Kimura T, Hayashida H, Murata M, Takamatsu J. Effect of ferulic acid and Angelica archangelica extract on behavioral and psychological symptoms of dementia in frontotemporal lobar degeneration and dementia with Lewy bodies. Geriatr Gerontol Int. 2011 Jul;11(3):309-14. doi: 10.1111/j.1447-0594.2010.00687.x. Epub 2011 Jan 28.
PubMed 21272180
Lin SY, Lewis FM. Dementia friendly, dementia capable, and dementia positive: concepts to prepare for the future. Gerontologist. 2015 Apr;55(2):237-44. doi: 10.1093/geront/gnu122. Epub 2015 Feb 15.
PubMed 26035599
Lyketsos CG, Lopez O, Jones B, Fitzpatrick AL, Breitner J, DeKosky S. Prevalence of neuropsychiatric symptoms in dementia and mild cognitive impairment: results from the cardiovascular health study. JAMA. 2002 Sep 25;288(12):1475-83. doi: 10.1001/jama.288.12.1475.
PubMed 12243634
Kales HC, Kim HM, Zivin K, Valenstein M, Seyfried LS, Chiang C, Cunningham F, Schneider LS, Blow FC. Risk of mortality among individual antipsychotics in patients with dementia. Am J Psychiatry. 2012 Jan;169(1):71-9. doi: 10.1176/appi.ajp.2011.11030347. Epub 2011 Oct 31.
PubMed 22193526
Haupt M, Kurz A, Janner M. A 2-year follow-up of behavioural and psychological symptoms in Alzheimer's disease. Dement Geriatr Cogn Disord. 2000 May-Jun;11(3):147-52. doi: 10.1159/000017228.
PubMed 10765045
Wang F, Feng TY, Yang S, Preter M, Zhou JN, Wang XP. Drug Therapy for Behavioral and Psychological Symptoms of Dementia. Curr Neuropharmacol. 2016;14(4):307-13. doi: 10.2174/1570159x14666151208114232.
PubMed 26644152
Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013 Jan;9(1):63-75.e2. doi: 10.1016/j.jalz.2012.11.007.
PubMed 23305823

Want to know more?

Jason R David, B.A.

5034949240

dajaso@ohsu.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Behavioral and Psychiatric Symptoms of Dementia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feru-guard (Ferulic Acid and Angelica Archangelica Extract) for Behavioral Symptoms in Dementia
ClinicalTrials.gov ID: NCT03451760
Acronym / sponsor ID: 17966
Conditions: Behavioral and Psychiatric Symptoms of Dementia
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 70 participants (estimated)
Lead sponsor: Glovia Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Oregon Health and Science University
Study start: Sep 2018 (estimated)
Primary completion: Dec 2019 (estimated)
Study completion: Dec 2019 (estimated)
First posted: 2 Mar 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized, double-blind, placebo-controlled clinical trial with a 12 week intervention period.

Arm	Type	Receives
Feru-guard	Experimental	Drug: Feru-guard 100MOver 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.
Placebo	Placebo comparator	Other: Feru-guard 100M PlaceboOver 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.

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (13 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Feru-guard 100MFeru-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.	Drug	Feru-guard
Feru-guard 100M PlaceboAlso: PlaceboIn 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	Placebo

Primary outcome

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.

3 secondary outcomes

Change from Baseline Neuropsychiatric Inventory Questionnaire subscale of caregiver distress at 12 weeks
Time frame: Administered 2 times 1 baseline, then 12 weeks later.
Change from Baseline Zarit Burden Interview Screening Version at 12 weeks
Time frame: Administered 2 times 1 baseline, then 12 weeks later.
Change from Baseline Short Form Health Survey 12-Item at 12 weeks
Time frame: Administered 2 times 1 baseline, then 12 weeks later.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
Background: PubMed 18225462Hersch EC, Falzgraf S. Management of the behavioral and psychological symptoms of dementia. Clin Interv Aging. 2007;2(4):611-21. doi: 10.2147/cia.s1698.
Background: PubMed 26693477de Oliveira AM, Radanovic M, de Mello PC, Buchain PC, Vizzotto AD, Celestino DL, Stella F, Piersol CV, Forlenza OV. Nonpharmacological Interventions to Reduce Behavioral and Psychological Symptoms of Dementia: A Systematic Review. Biomed Res Int. 2015;2015:218980. doi: 10.1155/2015/218980. Epub 2015 Nov 29.
Background: PubMed 18849899Dorey JM, Beauchet O, Thomas Anterion C, Rouch I, Krolak-Salmon P, Gaucher J, Gonthier R, Akiskal HS. Behavioral and psychological symptoms of dementia and bipolar spectrum disorders: review of the evidence of a relationship and treatment implications. CNS Spectr. 2008 Sep;13(9):796-803. doi: 10.1017/s1092852900013924.
Background: PubMed 12807576Adams BE, Tunis SL, Edell WS. Assessing antipsychotic effectiveness in dementia with the factor structure of the Psychogeriatric Dependency Rating Scale (PGDRS). J Am Med Dir Assoc. 2003 Mar-Apr;4(2):61-6. doi: 10.1097/01.JAM.0000052521.47659.7E.
Background: PubMed 11237317Herrmann N. Recommendations for the management of behavioral and psychological symptoms of dementia. Can J Neurol Sci. 2001 Feb;28 Suppl 1:S96-107. doi: 10.1017/s0317167100001268.
BackgroundKar N. Behavioural and Psychological Symptoms of Dementia. In: Kar N, Jolley D, Misra N, editors. Handbook of Dementia. Hyderabad: Paras Medical Publisher; 2005. pp. 54-74.
Background: PubMed 14564129Wynn ZJ, Cummings JL. Cholinesterase inhibitor therapies and neuropsychiatric manifestations of Alzheimer's disease. Dement Geriatr Cogn Disord. 2004;17(1-2):100-8. doi: 10.1159/000074281. Epub 2003 Oct 15.
Background: PubMed 23409038Mori T, Koyama N, Guillot-Sestier MV, Tan J, Town T. Ferulic acid is a nutraceutical beta-secretase modulator that improves behavioral impairment and alzheimer-like pathology in transgenic mice. PLoS One. 2013;8(2):e55774. doi: 10.1371/journal.pone.0055774. Epub 2013 Feb 8.
Background: PubMed 21272180Kimura T, Hayashida H, Murata M, Takamatsu J. Effect of ferulic acid and Angelica archangelica extract on behavioral and psychological symptoms of dementia in frontotemporal lobar degeneration and dementia with Lewy bodies. Geriatr Gerontol Int. 2011 Jul;11(3):309-14. doi: 10.1111/j.1447-0594.2010.00687.x. Epub 2011 Jan 28.
Background: PubMed 26035599Lin SY, Lewis FM. Dementia friendly, dementia capable, and dementia positive: concepts to prepare for the future. Gerontologist. 2015 Apr;55(2):237-44. doi: 10.1093/geront/gnu122. Epub 2015 Feb 15.
Background: PubMed 12243634Lyketsos CG, Lopez O, Jones B, Fitzpatrick AL, Breitner J, DeKosky S. Prevalence of neuropsychiatric symptoms in dementia and mild cognitive impairment: results from the cardiovascular health study. JAMA. 2002 Sep 25;288(12):1475-83. doi: 10.1001/jama.288.12.1475.
Background: PubMed 22193526Kales HC, Kim HM, Zivin K, Valenstein M, Seyfried LS, Chiang C, Cunningham F, Schneider LS, Blow FC. Risk of mortality among individual antipsychotics in patients with dementia. Am J Psychiatry. 2012 Jan;169(1):71-9. doi: 10.1176/appi.ajp.2011.11030347. Epub 2011 Oct 31.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jason R David, B.A. contact

5034949240

dajaso@ohsu.edu

Lynne Shinto, N.D., M.P.H. principal investigator

Oregon Health and Science University

Sarah Goodlin, M.D. principal investigator

Portland VA, Oregon Health and Science University

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Feru-guard 100M in people with Behavioral and Psychiatric Symptoms of Dementia, run by Glovia Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jason R David, B.A. (5034949240, dajaso@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Neuropsychiatric Inventory Questionnaire at 12 weeks (time frame: Administered 2 times 1 baseline, then 12 weeks later.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03451760, which also lists 60 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.