Alzheimer DiseaseNCT04094129
Evaluation of the Effect of Wismemo on Alzheimer's Dementia Patients
A study testing Wismemo in people with Alzheimer Disease, run by GenMont Biotech Incorporation.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 95 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Wismemo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 11 Feb 2020
- 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 55 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Subjects with administrating cholinesterase inhibitors, such as donepezil, rivastigmine, galantamine.
- Subjects in age of 55-95 years old.
Who cannot join
- Subjects are mixed dementia and vascular dementia.
- Administration of probiotic dietary supplement 2 weeks before inclusion expect for yakult or yogurt.
- Participation in other clinical trials.
- Subjects with thyroid dysfunction.
- Subjects are receiving cancer drugs.
- Subjects are receiving immunosuppressant drugs.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Wismemo, Placebo
- Keywords
- Alzheimer's disease, Dementia, Intestinal microbiota, Chronic inflammation, Probiotics
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WismemoDietary supplement
Also called Regular treatment with Wismemo
Multi-strain probiotic supplement includes Lactobacillus reuteri GMNL-89, Lactobacillus paracasei GMNL-133 and Lactobacillus plantarum GMNL-141.
PlaceboDietary supplement
Also called Regular treatment with placebo
placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects received two placebo sachets per day Receives: Dietary Supplement: Placebo |
| Probiotic | Experimental | Subjects received two Wismemo sachets with 1x10^10 cfu/day Receives: Dietary Supplement: Wismemo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination (MMSE) for efficacy
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.
Measured: 0, 3, 6 months
Secondary outcomes (12)
Neuropsychiatric Inventory (NPI) for efficacy and quality of life
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.
Measured: 0, 3, 6 months
Change from baseline in levels of peroxidation and antioxidant profiles (MDA and TAC)
Serum levels may possibly decrease peroxidation or increase antioxidant effects of probiotics.
Measured: 0 and 6 months
Change from baseline in levels of inflammatory markers (IL-10,IL-6, IL-1 beta, TNF-alpha and TGF-beta)
Serum levels may possibly decrease inflammatory or increase anti-inflammatory effects of probiotics.
Measured: 0 and 6 months
Change from baseline in levels of inflammatory markers (hs-CRP)
Serum levels may possibly decrease inflammatory effects of probiotics.
Measured: 0 and 6 months
Change from baseline in levels of blood sugar (HbA1c)
Serum levels may possibly decrease high blood sugar effect of probiotics.
Measured: 0 and 6 months
Change from baseline in levels of insulin resistance profile (FPG, insulin and HOMA-IR)
Serum levels may possibly decrease insulin resistance effect of probiotics.
Measured: 0 and 6 months
Gut microbiota for efficacy
Stool samples at baseline and after intervention will be collected. Gut microbiota profile will be assessed.
Measured: 0 and 6 months
Mini-Nutritional Assessment (MNA) for feasibility and efficacy
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.
Measured: 0, 3, 6 months
Defecation frequency and type for feasibility and efficacy
Change in Defecation frequency and type Defecation frequency and type will be assessed at baseline and after intervention.
Measured: 0, 3, 6 months
Zarit's Caregiver Burden Scale for quality of life
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.
Measured: 0, 3, 6 months
Brief Symptom Rating Scale for quality of life
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.
Measured: 0, 3, 6 months
Fatigue scale for quality of life
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.
Measured: 0, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start1 Jan 2020
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
Why it stopped: Couldn't sign the contract
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GenMont Biotech Incorporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Nai-Ching Chen, M.D., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094129
- Sponsor's protocol ID
- 201801746A3
- Status last verified
- Feb 2020
- First submitted
- 4 Sep 2019
- Last updated
- 13 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Probiotic Supplementation on Cognitive, Emotional and Related Status on Alzheimer's Dementia Patients
- ClinicalTrials.gov ID
- NCT04094129
- Acronym / sponsor ID
- 201801746A3
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's disease, Dementia, Intestinal microbiota, Chronic inflammation, Probiotics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Couldn't sign the contract
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GenMont Biotech IncorporationIndustry (pharma, biotech, devices)
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 18 Sep 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects received two placebo sachets per day |
| Probiotic | Experimental | Dietary Supplement: WismemoSubjects received two Wismemo sachets with 1x10^10 cfu/day |
Who may qualify
- Ages
- 55 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
- Subjects with administrating cholinesterase inhibitors, such as donepezil, rivastigmine, galantamine.
- Subjects in age of 55-95 years old.
Key exclusion criteria (6 listed)
- Subjects are mixed dementia and vascular dementia.
- Administration of probiotic dietary supplement 2 weeks before inclusion expect for yakult or yogurt.
- Participation in other clinical trials.
- Subjects with thyroid dysfunction.
- Subjects are receiving cancer drugs.
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 |
|---|---|---|
| WismemoAlso: Regular treatment with WismemoMulti-strain probiotic supplement includes Lactobacillus reuteri GMNL-89, Lactobacillus paracasei GMNL-133 and Lactobacillus plantarum GMNL-141. | Dietary supplement | Probiotic |
| PlaceboAlso: Regular treatment with placeboplacebo | Dietary supplement | Placebo |
Primary outcome
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.
12 secondary outcomes
Neuropsychiatric Inventory (NPI) for efficacy and quality of life
Time frame: 0, 3, 6 months
Change from baseline in levels of peroxidation and antioxidant profiles (MDA and TAC)
Time frame: 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
Change from baseline in levels of inflammatory markers (hs-CRP)
Time frame: 0 and 6 months
Change from baseline in levels of blood sugar (HbA1c)
Time frame: 0 and 6 months
Change from baseline in levels of insulin resistance profile (FPG, insulin and HOMA-IR)
Time frame: 0 and 6 months
Gut microbiota for efficacy
Time frame: 0 and 6 months
Mini-Nutritional Assessment (MNA) for feasibility and efficacy
Time frame: 0, 3, 6 months
Defecation frequency and type for feasibility and efficacy
Time frame: 0, 3, 6 months
Zarit's Caregiver Burden Scale for quality of life
Time frame: 0, 3, 6 months
Brief Symptom Rating Scale for quality of life
Time frame: 0, 3, 6 months
Fatigue scale for quality of life
Time frame: 0, 3, 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
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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.
Nai-Ching Chen, M.D. principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Wismemo in people with Alzheimer Disease, run by GenMont Biotech Incorporation.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 13 Feb 2020. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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) for efficacy (time frame: 0, 3, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2020.