Clinical trial NCT04094129: Evaluation of the Effect of Wismemo on Alzheimer's Dementia Patients
Official title: Evaluation of the Effect of Probiotic Supplementation on Cognitive, Emotional and Related Status on Alzheimer's Dementia Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer's disease
Dementia
Intestinal microbiota
Chronic inflammation
Probiotics
Lead sponsor: GenMont Biotech Incorporation
Sponsor class: INDUSTRY
Collaborators: name: Chang Gung Memorial Hospital
First posted: 2019-09-18
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mini-Mental State Examination (MMSE) for efficacy
timeFrame: 0, 3, 6 months
Secondary outcomes:
measure: Neuropsychiatric Inventory (NPI) for efficacy and quality of life
timeFrame: 0, 3, 6 months
measure: Change from baseline in levels of peroxidation and antioxidant profiles (MDA and TAC)
timeFrame: 0 and 6 months
measure: Change from baseline in levels of inflammatory markers (IL-10,IL-6, IL-1 beta, TNF-alpha and TGF-beta)
timeFrame: 0 and 6 months
measure: Change from baseline in levels of inflammatory markers (hs-CRP)
timeFrame: 0 and 6 months
measure: Change from baseline in levels of blood sugar (HbA1c)
timeFrame: 0 and 6 months
measure: Change from baseline in levels of insulin resistance profile (FPG, insulin and HOMA-IR)
timeFrame: 0 and 6 months
measure: Gut microbiota for efficacy
timeFrame: 0 and 6 months
measure: Mini-Nutritional Assessment (MNA) for feasibility and efficacy
timeFrame: 0, 3, 6 months
measure: Defecation frequency and type for feasibility and efficacy
timeFrame: 0, 3, 6 months
measure: Zarit's Caregiver Burden Scale for quality of life
timeFrame: 0, 3, 6 months
measure: Brief Symptom Rating Scale for quality of life
timeFrame: 0, 3, 6 months
measure: Fatigue scale for quality of life
timeFrame: 0, 3, 6 months
Other outcomes:
measure: Drug Records for feasibility and efficacy
timeFrame: 0, 3, 6 months
measure: Adverse Events (AE) for feasibility and safety
timeFrame: 0, 3, 6 months
measure: Change from baseline in levels of complete blood count and white blood cell differential count
timeFrame: 0 and 6 months
measure: Change from baseline in levels of AST and ALT
timeFrame: 0 and 6 months
measure: Change from baseline in levels of BUN, creatinine, microalbumin, GFR, ACR and urine routine examination
timeFrame: 0 and 6 months
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Nai-Ching Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: