Evaluation of the Effect of Wismemo on Alzheimer's Dementia Patients

February 11, 2020 updated by: GenMont Biotech Incorporation

Evaluation of the Effect of Probiotic Supplementation on Cognitive, Emotional and Related Status on Alzheimer's Dementia Patients

The present studies demonstrated that pro-inflammation, systemic oxidative stress and dysfunction in the brain-gut microbiota axis were involved in Alzheimer's disease (AD) pathogenesis. These results implied the decreased regulation of inflammation-associated risk and microbiota in AD patients could provide the novel strategies for combating the disease. This study was designed to assess the addition of Wismemo in treatment of cholinesterase inhibitors (such as donepezil, rivastigmine, galantamine) in the AD patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Previously studies have shown some probiotics could improve stress-related diseases such as anxiety, autism, depression and schizophrenia might be through regulating brain-gut microbiota axis, pro-inflammation and oxidative stress. Although recent clinical study indicated that mix-probiotics (containing Lactobacillus acidophilus, Lactobacillus casei, Bifidobacteria bifidum and Lactobacillus fermentum) consumption could improve the cognitive function of dementia patients.

In this clinical study, whether Genmont specific strain probiotics could improve the clinical syndromes and delay worsens in Alzheimer's dementia patients with regular treatment were clarified. A Randomized, double-blind, placebo-controlled clinical trial would be carried out. AD's patients with regular treatment are additive consumption multi-strain probiotic supplement (Wismemo). Half of participants will receive Wismeno and regular treatment in combination, while the other half will receive placebo and regular treatment in combination. To evaluate of the effect of probiotic supplementation on cognitive, emotional and related status on Alzheimer's dementia patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects with Alzheimer's Dementia. (According to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association diagnostic criteria (NINCDS-ADRDA) and new criteria and guidelines to diagnose Alzheimer's disease were published in 2011 by the National Institute on Aging and Alzheimer's Association)
  2. Subjects with administrating cholinesterase inhibitors, such as donepezil, rivastigmine, galantamine.
  3. Subjects in age of 55-95 years old.

Exclusion Criteria:

  1. Subjects are mixed dementia and vascular dementia.
  2. Administration of probiotic dietary supplement 2 weeks before inclusion expect for yakult or yogurt.
  3. Participation in other clinical trials.
  4. Subjects with thyroid dysfunction.
  5. Subjects are receiving cancer drugs.
  6. Subjects are receiving immunosuppressant drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Subjects received two placebo sachets per day
Dietary supplement: Placebo
placebo
Other Names:
  • Regular treatment with placebo
Experimental: Probiotic
Subjects received two Wismemo sachets with 1x10^10 cfu/day
Dietary supplement: Wismemo
Multi-strain probiotic supplement includes Lactobacillus reuteri GMNL-89, Lactobacillus paracasei GMNL-133 and Lactobacillus plantarum GMNL-141.
Other Names:
  • Regular treatment with Wismemo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mini-Mental State Examination (MMSE) for efficacy
Time Frame: 0, 3, 6 months
Change in cognitive status was evaluated using the Mini-Mental State Examination (MMSE). MMSE will be assessed at baseline and after intervention. The maximum score is 30. If the scores are less than 24, it would be assessed to the mild dementia. If the scores are less than 16, it would be assessed to the severe dementia.
0, 3, 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neuropsychiatric Inventory (NPI) for efficacy and quality of life
Time Frame: 0, 3, 6 months
Change from baseline in scores of psychosocial scale and caregiver distress was evaluated using the neuropsychiatric Inventory (NPI) by 12 items respectively. The 12 items include delusion, fantasy, depression, anxiety, etc., The maximum score of psychosocial scale is 144. The maximum score of caregiver distress is 60. Change in scores of total and each item will be assessed at baseline and after intervention.
0, 3, 6 months
Change from baseline in levels of peroxidation and antioxidant profiles (MDA and TAC)
Time Frame: 0 and 6 months
Serum levels may possibly decrease peroxidation or increase antioxidant effects of probiotics.
0 and 6 months
Change from baseline in levels of inflammatory markers (IL-10,IL-6, IL-1 beta, TNF-alpha and TGF-beta)
Time Frame: 0 and 6 months
Serum levels may possibly decrease inflammatory or increase anti-inflammatory effects of probiotics.
0 and 6 months
Change from baseline in levels of inflammatory markers (hs-CRP)
Time Frame: 0 and 6 months
Serum levels may possibly decrease inflammatory effects of probiotics.
0 and 6 months
Change from baseline in levels of blood sugar (HbA1c)
Time Frame: 0 and 6 months
Serum levels may possibly decrease high blood sugar effect of probiotics.
0 and 6 months
Change from baseline in levels of insulin resistance profile (FPG, insulin and HOMA-IR)
Time Frame: 0 and 6 months
Serum levels may possibly decrease insulin resistance effect of probiotics.
0 and 6 months
Gut microbiota for efficacy
Time Frame: 0 and 6 months
Stool samples at baseline and after intervention will be collected. Gut microbiota profile will be assessed.
0 and 6 months
Mini-Nutritional Assessment (MNA) for feasibility and efficacy
Time Frame: 0, 3, 6 months
Change in Mini-Nutritional Assessment (MNA) MNA will be assessed at baseline and after intervention. The maximum score is 14. If the scores are 12-14, it would be assessed to normal malnutrition. If the scores are less than 12, it would be assessed to have the risk of malnutrition. If the scores are less than 8, it would be assessed to the malnutrition.
0, 3, 6 months
Defecation frequency and type for feasibility and efficacy
Time Frame: 0, 3, 6 months
Change in Defecation frequency and type Defecation frequency and type will be assessed at baseline and after intervention.
0, 3, 6 months
Zarit's Caregiver Burden Scale for quality of life
Time Frame: 0, 3, 6 months
Change in total scores of Zarit's Caregiver Burden Scale will be assessed at baseline and after intervention for caregiver stress. The maximum score is 48. The minimum score is 0. If the scores are 0-10, it would be assessed to no to mild burden. If the scores are 10-20, it would be assessed to mild to moderate burden. If the scores are greater than 20, it would be assessed to high burden.
0, 3, 6 months
Brief Symptom Rating Scale for quality of life
Time Frame: 0, 3, 6 months
Change in total scores of Brief Symptom Rating Scale (BSRS-5) will be assessed at baseline and after intervention for caregiver stress. The maximum score is 24. The minimum score is 0. If the scores are 0-5, it would be assessed to good. If the scores are 6-9, it would be assessed to mild emotional distress. If the scores are 10-14, it would be assessed to moderate emotional distress. If the scores are greater than or equal t 15, it would be assessed to severe emotional distress.
0, 3, 6 months
Fatigue scale for quality of life
Time Frame: 0, 3, 6 months
Change in total scores of Fatigue scale will be assessed at baseline and after intervention for caregiver stress. The maximum score is 63. The minimum score is 9.
0, 3, 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Drug Records for feasibility and efficacy
Time Frame: 0, 3, 6 months
Drug Records including the dosage and frequency The major drugs including cholinesterase inhibitors, such as donepezil, rivastigmine, galantamine will be assessed at baseline and after intervention.
0, 3, 6 months
Adverse Events (AE) for feasibility and safety
Time Frame: 0, 3, 6 months
Expected AE including constipation, diarrhea, flatulence and others gastrointestinal symptoms, unexpected or suspected adverse reaction will be assessed at baseline and after intervention. The AE will be reported by numbers of participants and ratio with different symptoms. And concern the AE of cholinesterase inhibitors with probiotic.
0, 3, 6 months
Change from baseline in levels of complete blood count and white blood cell differential count
Time Frame: 0 and 6 months
To assess the safety after intervention using blood samples.
0 and 6 months
Change from baseline in levels of AST and ALT
Time Frame: 0 and 6 months
To assess the liver toxicity after intervention using blood samples.
0 and 6 months
Change from baseline in levels of BUN, creatinine, microalbumin, GFR, ACR and urine routine examination
Time Frame: 0 and 6 months
To assess the kidney toxicity after intervention using blood and urine samples.
0 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GenMont Biotech Incorporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nai-Ching Chen, M.D., Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201801746A3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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