SupplementNCT04065061
Erinacine A-enriched Hericium Erinaceus Mycelia for Improvement of Recognition, Vision, and Functional MRI Alterations
A study testing Erinacine A-enriched Hericium Erinaceus Mycelia in people with Supplement and Cognition Disorders in Old Age, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
This study was designed as randomized double blind placebo study to investigate the efficacy of Erinacine A-enriched Hericium erinaceus mycelia for improvement of recognition, vision, and functional MRI alterations. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Supplement, Cognition Disorders in Old Age, Vision
- What is being tested?
- Erinacine A-enriched Hericium Erinaceus Mycelia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 May 2015to 10 May 2017
- Phase
- Interventional
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 50 and 90
- Confirmed diagnosis of mild and intermediate Alzheimer's disease based on clinical assessments according to criteria of NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association)
Who cannot join
- vulnerable to injuries
- loss of self-recognition,
- loss of behavioral capacity
- with critical illness
- with major diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Erinacine A-enriched Hericium Erinaceus Mycelia for Improvement of Recognition, Vision, and Functional MRI Alterations
This study was designed as randomized double blind placebo study to investigate the efficacy of Erinacine A-enriched Hericium erinaceus mycelia for improvement of recognition, vision, and functional MRI alterations.
Read the detailed description
Patients were recruited with diagnosis of mild or medium dementia, according to criteria by NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association) as probable or possible Alzheimer's disease. Upon signature of informed consent, they were subject to: (1) Cognitive assessments, including Mini-Mental State Examination(MMSE), Neuropsychiatric Inventory (NPI), Cognitive Abilities Screening Instrument (CASI), and Instrumental Activities of Daily Living (IADL) on weeks 0, 12, 24, and 49, (2) Blood Markers Tests, including DHEAS, Alpha 1-antichymotrypsin, Superoxide Dismutase, and Homocysteine, Apolipoprotein E, Hemoglobin, Calcium, Albumin, and Amyloid Beta on weeks 0, 24, and 49, (3) fMRI Assessments for Super-resolution Track Density Imaging (TDI), and Blood Oxygenation Level-Dependent (BOLD) Signal Mapping, on weeks 0 and 49, (4) Vision Assessments, including Visual Acuity (VA) and Contrast Sensitivity (CS), on weeks 0, 24, and 49. Mann-Whitney U test and Wilcoxon tests were applied to examine the data before and after dietary intake of Erinacine A-enriched Hericium Erinaceus Mycelia after 49 weeks.
- Conditions
- Supplement, Cognition Disorders in Old Age, Vision, fMRI
- Being tested
- Erinacine A-enriched Hericium Erinaceus Mycelia, Placebo
- Keywords
- Erinacine A, supplement, Alzheimer's disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erinacine A-enriched Hericium Erinaceus MyceliaDietary supplement
PlaceboDietary supplement
Placebo supplement was given to the participants.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Erinacine A-enriched Hericium Erinaceus Mycelia dietary supplement from week 0 to week 49. Receives: Dietary Supplement: Erinacine A-enriched Hericium Erinaceus Mycelia |
| Placebo | Placebo comparator | Placebo dietary supplement from week 0 to week 49. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination(MMSE)
Assess changes of Mini-Mental State Examination(MMSE) on weeks 0, 12, 24, and 49.
Measured: weeks 0,12, 24, and 49
Neuropsychiatric Inventory (NPI)
Assess changes of Neuropsychiatric Inventory (NPI) on weeks 0, 12, 24, and 49.
Measured: weeks 0,12, 24, and 49
Cognitive Abilities Screening Instrument (CASI)
Assess changes of Cognitive Abilities Screening Instrument (CASI) on weeks 0, 12, 24, and 49.
Measured: weeks 0,12, 24, and 49
Instrumental Activities of Daily Living (IADL)
Assess changes of Instrumental Activities of Daily Living (IADL) on weeks 0, 12, 24, and 49.
Measured: weeks 0,12, 24, and 49
Dehydroepiandrosterone sulfate (DHEAS)
Assess changes of DHEAS on weeks 0, 24, and 49.
Measured: weeks 0, 24, and 49
Alpha 1-antichymotrypsin
Assess changes of Alpha 1-antichymotrypsinon weeks 0, 24, and 49.
Measured: weeks 0, 24, and 49
Superoxide Dismutase
Assess changes of Superoxide Dismutase on weeks 0, 24, and 49.
Measured: weeks 0, 24, and 49
Homocysteine
Assess changes of Homocysteine on weeks 0, 24, and 49.
Measured: weeks 0, 24, and 49
Apolipoprotein E
Assess changes of Apolipoprotein E on weeks 0, 24, and 49.
Measured: weeks 0, 24, and 49
Hemoglobin
Assess changes of Hemoglobin on weeks 0, 24, and 49.
Measured: weeks 0, 24, and 49
Calcium
Assess changes of Calcium on weeks 0, 24, and 49.
Measured: weeks 0, 24, and 49
Albumin
Assess changes of Albumin on weeks 0, 24, and 49.
Measured: weeks 0, 24, and 49
Amyloid Beta
Assess changes of Amyloid Beta on weeks 0, 24, and 49.
Measured: weeks 0, 24, and 49
fMRI-Super-resolution Track Density Imaging (TDI)
Assess changes of Super-resolution Track Density Imaging (TDI) on weeks 0 and 49.
Measured: weeks 0 and 49
fMRI-Blood Oxygenation Level-Dependent (BOLD) Signal Mapping
Assess changes of Blood Oxygenation Level-Dependent (BOLD) Signal Mapping, on weeks 0 and 49.
Measured: weeks 0 and 49
Vision Assessments-Visual Acuity (VA)
Assess changes of Visual Acuity (VA) on weeks 0, 24, and 49.
Measured: weeks 0, 24, and 49
Vision Assessments-Contrast Sensitivity (CS)
Assess changes of Contrast Sensitivity (CS) on weeks 0, 24, and 49.
Measured: weeks 0, 24, and 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start22 May 2015
- Primary completion10 May 2016
- Study completion10 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SupplementStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Double Blinded placebo study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Responsible party
- Principal investigator, David Pei-Cheng Lin, Chung Shan Medical University
- Investigators
- David Pei-Cheng Lin, PhD, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065061
- Sponsor's protocol ID
- CS15049
- Status last verified
- Aug 2019
- First submitted
- 15 Aug 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li IC, Chang HH, Lin CH, Chen WP, Lu TH, Lee LY, Chen YW, Chen YP, Chen CC, Lin DP. Prevention of Early Alzheimer's Disease by Erinacine A-Enriched Hericium erinaceus Mycelia Pilot Double-Blind Placebo-Controlled Study. Front Aging Neurosci. 2020 Jun 3;12:155. doi: 10.3389/fnagi.2020.00155. eCollection 2020.
PubMed 32581767
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Erinacine A-enriched Hericium Erinaceus Mycelia for Improvement of Recognition, Vision, and Functional MRI Alterations
- ClinicalTrials.gov ID
- NCT04065061
- Acronym / sponsor ID
- CS15049
- Conditions
- Supplement, Cognition Disorders in Old Age, Vision, fMRI
- Keywords
- Erinacine A, supplement, Alzheimer's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Study start
- 22 May 2015 (actual)
- Primary completion
- 10 May 2016 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 22 Aug 2019 (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.
This study was designed as randomized double blind placebo study to investigate the efficacy of Erinacine A-enriched Hericium erinaceus mycelia for improvement of recognition, vision, and functional MRI alterations.
Detailed description
Patients were recruited with diagnosis of mild or medium dementia, according to criteria by NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association) as probable or possible Alzheimer's disease. Upon signature of informed consent, they were subject to: (1) Cognitive assessments, including Mini-Mental State Examination(MMSE), Neuropsychiatric Inventory (NPI), Cognitive Abilities Screening Instrument (CASI), and Instrumental Activities of Daily Living (IADL) on weeks 0, 12, 24, and 49, (2) Blood Markers Tests, including DHEAS, Alpha 1-antichymotrypsin, Superoxide Dismutase, and Homocysteine, Apolipoprotein E, Hemoglobin, Calcium, Albumin, and Amyloid Beta on weeks 0, 24, and 49, (3) fMRI Assessments for Super-resolution Track Density Imaging (TDI), and Blood Oxygenation Level-Dependent (BOLD) Signal Mapping, on weeks 0 and 49, (4) Vision Assessments, including Visual Acuity (VA) and Contrast Sensitivity (CS), on weeks 0, 24, and 49. Mann-Whitney U test and Wilcoxon tests were applied to examine the data before and after dietary intake of Erinacine A-enriched Hericium Erinaceus Mycelia after 49 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized Double Blinded placebo study
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: Erinacine A-enriched Hericium Erinaceus MyceliaErinacine A-enriched Hericium Erinaceus Mycelia dietary supplement from week 0 to week 49. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo dietary supplement from week 0 to week 49. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged between 50 and 90
- Confirmed diagnosis of mild and intermediate Alzheimer's disease based on clinical assessments according to criteria of NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association)
Key exclusion criteria (5 listed)
- vulnerable to injuries
- loss of self-recognition,
- loss of behavioral capacity
- with critical illness
- with major diseases
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 |
|---|---|---|
| Erinacine A-enriched Hericium Erinaceus Mycelia | Dietary supplement | Experimental |
| PlaceboPlacebo supplement was given to the participants. | Dietary supplement | Placebo |
Primary outcome
Mini-Mental State Examination(MMSE)
Time frame: weeks 0,12, 24, and 49
Assess changes of Mini-Mental State Examination(MMSE) on weeks 0, 12, 24, and 49.
Neuropsychiatric Inventory (NPI)
Time frame: weeks 0,12, 24, and 49
Assess changes of Neuropsychiatric Inventory (NPI) on weeks 0, 12, 24, and 49.
Cognitive Abilities Screening Instrument (CASI)
Time frame: weeks 0,12, 24, and 49
Assess changes of Cognitive Abilities Screening Instrument (CASI) on weeks 0, 12, 24, and 49.
Instrumental Activities of Daily Living (IADL)
Time frame: weeks 0,12, 24, and 49
Assess changes of Instrumental Activities of Daily Living (IADL) on weeks 0, 12, 24, and 49.
Dehydroepiandrosterone sulfate (DHEAS)
Time frame: weeks 0, 24, and 49
Assess changes of DHEAS on weeks 0, 24, and 49.
Alpha 1-antichymotrypsin
Time frame: weeks 0, 24, and 49
Assess changes of Alpha 1-antichymotrypsinon weeks 0, 24, and 49.
Superoxide Dismutase
Time frame: weeks 0, 24, and 49
Assess changes of Superoxide Dismutase on weeks 0, 24, and 49.
Homocysteine
Time frame: weeks 0, 24, and 49
Assess changes of Homocysteine on weeks 0, 24, and 49.
Apolipoprotein E
Time frame: weeks 0, 24, and 49
Assess changes of Apolipoprotein E on weeks 0, 24, and 49.
Hemoglobin
Time frame: weeks 0, 24, and 49
Assess changes of Hemoglobin on weeks 0, 24, and 49.
Calcium
Time frame: weeks 0, 24, and 49
Assess changes of Calcium on weeks 0, 24, and 49.
Albumin
Time frame: weeks 0, 24, and 49
Assess changes of Albumin on weeks 0, 24, and 49.
Amyloid Beta
Time frame: weeks 0, 24, and 49
Assess changes of Amyloid Beta on weeks 0, 24, and 49.
fMRI-Super-resolution Track Density Imaging (TDI)
Time frame: weeks 0 and 49
Assess changes of Super-resolution Track Density Imaging (TDI) on weeks 0 and 49.
fMRI-Blood Oxygenation Level-Dependent (BOLD) Signal Mapping
Time frame: weeks 0 and 49
Assess changes of Blood Oxygenation Level-Dependent (BOLD) Signal Mapping, on weeks 0 and 49.
Vision Assessments-Visual Acuity (VA)
Time frame: weeks 0, 24, and 49
Assess changes of Visual Acuity (VA) on weeks 0, 24, and 49.
Vision Assessments-Contrast Sensitivity (CS)
Time frame: weeks 0, 24, and 49
Assess changes of Contrast Sensitivity (CS) on weeks 0, 24, and 49.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Derived from this study: PubMed 32581767Li IC, Chang HH, Lin CH, Chen WP, Lu TH, Lee LY, Chen YW, Chen YP, Chen CC, Lin DP. Prevention of Early Alzheimer's Disease by Erinacine A-Enriched Hericium erinaceus Mycelia Pilot Double-Blind Placebo-Controlled Study. Front Aging Neurosci. 2020 Jun 3;12:155. doi: 10.3389/fnagi.2020.00155. eCollection 2020.
- 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.
David Pei-Cheng Lin, PhD principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erinacine A-enriched Hericium Erinaceus Mycelia in people with Supplement and Cognition Disorders in Old Age, run by Chung Shan Medical University at 1 site in Taiwan.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination(MMSE) (time frame: weeks 0,12, 24, and 49). The study lists 17 primary outcomes in all. 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 NCT04065061, which also lists 1 linked publication.
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 22 Aug 2019.