NCT04094129

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable alzheimer-disease

Status
withdrawn

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

First Submitted

Initial submission to the registry

September 4, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2020

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

1 month

First QC Date

September 4, 2019

Last Update Submit

February 11, 2020

Conditions

Alzheimer Disease

Keywords

Alzheimer's diseaseDementiaIntestinal microbiotaChronic inflammationProbiotics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Neuropsychiatric Inventory (NPI) for efficacy and quality of life

    0, 3, 6 months

  • Change from baseline in levels of peroxidation and antioxidant profiles (MDA and TAC)

    0 and 6 months

  • Change from baseline in levels of inflammatory markers (IL-10,IL-6, IL-1 beta, TNF-alpha and TGF-beta)

    0 and 6 months

  • Change from baseline in levels of inflammatory markers (hs-CRP)

    0 and 6 months

  • Change from baseline in levels of blood sugar (HbA1c)

    0 and 6 months

  • +7 more secondary outcomes

Other Outcomes (5)

  • Drug Records for feasibility and efficacy

    0, 3, 6 months

  • Adverse Events (AE) for feasibility and safety

    0, 3, 6 months

  • Change from baseline in levels of complete blood count and white blood cell differential count

    0 and 6 months

  • +2 more other outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects received two placebo sachets per day

Dietary Supplement: Placebo

Probiotic

EXPERIMENTAL

Subjects received two Wismemo sachets with 1x10\^10 cfu/day

Dietary Supplement: Wismemo

Interventions

WismemoDIETARY_SUPPLEMENT

Multi-strain probiotic supplement includes Lactobacillus reuteri GMNL-89, Lactobacillus paracasei GMNL-133 and Lactobacillus plantarum GMNL-141.

Also known as: Regular treatment with Wismemo
Probiotic
PlaceboDIETARY_SUPPLEMENT

placebo

Also known as: Regular treatment with placebo
Placebo

Eligibility Criteria

Age55 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects are mixed dementia and vascular dementia.
  • Participation in other clinical trials.
  • Subjects with thyroid dysfunction.
  • Subjects are receiving cancer drugs.
  • Subjects are receiving immunosuppressant drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Nai-Ching Chen, M.D.

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2019

First Posted

September 18, 2019

Study Start

January 1, 2020

Primary Completion

February 11, 2020

Study Completion

February 11, 2020

Last Updated

February 13, 2020

Record last verified: 2020-02