NCT04065061

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

12 months

First QC Date

August 15, 2019

Last Update Submit

August 20, 2019

Conditions

SupplementCognition Disorders in Old AgeVisionfMRI

Keywords

Erinacine A, supplement, Alzheimer's disease

Outcome Measures

Primary Outcomes (17)

  • Mini-Mental State Examination(MMSE)

    Assess changes of Mini-Mental State Examination(MMSE) on weeks 0, 12, 24, and 49.

    weeks 0,12, 24, and 49

  • Neuropsychiatric Inventory (NPI)

    Assess changes of Neuropsychiatric Inventory (NPI) on weeks 0, 12, 24, and 49.

    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.

    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.

    weeks 0,12, 24, and 49

  • Dehydroepiandrosterone sulfate (DHEAS)

    Assess changes of DHEAS on weeks 0, 24, and 49.

    weeks 0, 24, and 49

  • Alpha 1-antichymotrypsin

    Assess changes of Alpha 1-antichymotrypsinon weeks 0, 24, and 49.

    weeks 0, 24, and 49

  • Superoxide Dismutase

    Assess changes of Superoxide Dismutase on weeks 0, 24, and 49.

    weeks 0, 24, and 49

  • Homocysteine

    Assess changes of Homocysteine on weeks 0, 24, and 49.

    weeks 0, 24, and 49

  • Apolipoprotein E

    Assess changes of Apolipoprotein E on weeks 0, 24, and 49.

    weeks 0, 24, and 49

  • Hemoglobin

    Assess changes of Hemoglobin on weeks 0, 24, and 49.

    weeks 0, 24, and 49

  • Calcium

    Assess changes of Calcium on weeks 0, 24, and 49.

    weeks 0, 24, and 49

  • Albumin

    Assess changes of Albumin on weeks 0, 24, and 49.

    weeks 0, 24, and 49

  • Amyloid Beta

    Assess changes of Amyloid Beta on weeks 0, 24, and 49.

    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.

    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.

    weeks 0 and 49

  • Vision Assessments-Visual Acuity (VA)

    Assess changes of Visual Acuity (VA) on weeks 0, 24, and 49.

    weeks 0, 24, and 49

  • Vision Assessments-Contrast Sensitivity (CS)

    Assess changes of Contrast Sensitivity (CS) on weeks 0, 24, and 49.

    weeks 0, 24, and 49

Study Arms (2)

Experimental

EXPERIMENTAL

Erinacine A-enriched Hericium Erinaceus Mycelia dietary supplement from week 0 to week 49.

Dietary Supplement: Erinacine A-enriched Hericium Erinaceus Mycelia

Placebo

PLACEBO COMPARATOR

Placebo dietary supplement from week 0 to week 49.

Dietary Supplement: Placebo

Interventions

Erinacine A-enriched Hericium Erinaceus MyceliaDIETARY_SUPPLEMENT
Experimental
PlaceboDIETARY_SUPPLEMENT

Placebo supplement was given to the participants.

Placebo

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • vulnerable to injuries
  • loss of self-recognition,
  • loss of behavioral capacity
  • with critical illness
  • with major diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 32581767DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • David Pei-Cheng Lin, PhD

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
to be completed
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized Double Blinded placebo study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2019

First Posted

August 22, 2019

Study Start

May 22, 2015

Primary Completion

May 10, 2016

Study Completion

May 10, 2017

Last Updated

August 22, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)