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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04094129
• Other study ID #: 201801746A3
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: February 11, 2020

Study information

• Verified date: February 2020
• Source: GenMont Biotech Incorporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 11, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Dietary Supplement:
• Wismemo
Multi-strain probiotic supplement includes Lactobacillus reuteri GMNL-89, Lactobacillus paracasei GMNL-133 and Lactobacillus plantarum GMNL-141.
• Placebo
placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
GenMont Biotech Incorporation	Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Drug Records for feasibility and efficacy	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
Other	Adverse Events (AE) for feasibility and safety	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
Other	Change from baseline in levels of complete blood count and white blood cell differential count	To assess the safety after intervention using blood samples.	0 and 6 months
Other	Change from baseline in levels of AST and ALT	To assess the liver toxicity after intervention using blood samples.	0 and 6 months
Other	Change from baseline in levels of BUN, creatinine, microalbumin, GFR, ACR and urine routine examination	To assess the kidney toxicity after intervention using blood and urine samples.	0 and 6 months
Primary	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.	0, 3, 6 months
Secondary	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.	0, 3, 6 months
Secondary	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.	0 and 6 months
Secondary	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.	0 and 6 months
Secondary	Change from baseline in levels of inflammatory markers (hs-CRP)	Serum levels may possibly decrease inflammatory effects of probiotics.	0 and 6 months
Secondary	Change from baseline in levels of blood sugar (HbA1c)	Serum levels may possibly decrease high blood sugar effect of probiotics.	0 and 6 months
Secondary	Change from baseline in levels of insulin resistance profile (FPG, insulin and HOMA-IR)	Serum levels may possibly decrease insulin resistance effect of probiotics.	0 and 6 months
Secondary	Gut microbiota for efficacy	Stool samples at baseline and after intervention will be collected. Gut microbiota profile will be assessed.	0 and 6 months
Secondary	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.	0, 3, 6 months
Secondary	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.	0, 3, 6 months
Secondary	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.	0, 3, 6 months
Secondary	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.	0, 3, 6 months
Secondary	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.	0, 3, 6 months