Intervention of Intestinal Microorganism in Mild Cognitive Impairment

NCT03991195 | Completed

• 1 other identifier: HanYingsc
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Alzheimer's disease (AD) is the most common form of neurodegenerative disorders leading to dementia. Currently, there has been no effective drugs targeting this disease. Dysbiosis of the gut microbiota is considered to be associated with AD, and probiotic supplementation may positively affect cognitive function. However, there are few studies involving the relationship between intestinal microorganism and amnestic mild cognitive impairment (aMCI). In this project, taking the method of random, double blindness and control, the probiotic supplemented group with aMCI will take certain Bifidobacterium for a certain time. After that, the investigators aim to investigate the improvement of cognitive function and changes of intestinal microbial flora diversity via combining neuropsychological tests and 16S recombinant deoxyribonucleic acid (rDNA) high-throughput sequencing technique. Furthermore, based on the multi-modal neuroimaging techniques, the regulatory mechanism of intestinal microorganism in intervening aMCI will be revealed from the perspective of brain networks. In conclusion, these results are beneficial for understanding the therapeutic effect of gut microbiota as a non-drug treatment for early AD and further elucidating the potential brain mechanism, which are of great values in solving scientific and clinical practice issues.

Conditions

Gut Microbiota; Mild Cognitive Impairment; Dementia, Alzheimer Type; Neuroimaging

Keywords

mild cognitive impairment; intestinal microorganism; regulation; magnetic resonance imaging

Outcome Measures

Primary Outcomes (3)

• Improvement of Montreal cognitive assessment (MoCA)

  After intervention for three months, the investigators first aim to compare cognitive changes of Montreal cognitive assessment (MoCA) among three groups, in order to investigate the therapeutic effectiveness of probiotic supplementation and functional foods.

  Three months

• Improvement of Auditory Verbal Learning Test (AVLT)

  After intervention for three months, the investigators will then compare cognitive changes of Auditory Verbal Learning Test (AVLT) among three groups, in order to investigate the therapeutic effectiveness of probiotic supplementation and functional foods.

  Three months

• Changes of intestinal microbial flora diversity

  After intervention for three months, the investigators will further compare the diversity changes of intestinal microbial flora, such as Lactobacteria species, Bifidobacterium, Enterococci, Propionobacteria, Peptostreptococci, etc., among three groups.

  Three months

Secondary Outcomes (3)

• Structural MRI-based brain network changes

  Three months

• Functional MRI-based brain network changes

  Three months

• FNIRS-based brain network changes

  Three months

Study Arms (2)

Probiotic supplemented group with aMCI

EXPERIMENTAL

Thirty participants in this group will take Bifidobacterium for three months.

Dietary Supplement: Probiotic supplemented intervention

Placebo group with aMCI

PLACEBO COMPARATOR

Thirty participants in this group will take placebo for three months.

Dietary Supplement: Placebo

Interventions

Probiotic supplemented intervention DIETARY_SUPPLEMENT

In this project, taking the method of random, double blindness and control, the probiotic supplemented group with aMCI will take Bifidobacterium for three months. After that, cognitive changes will be test to investigate the effectiveness of probiotic supplementation.

Probiotic supplemented group with aMCI

Placebo DIETARY_SUPPLEMENT

In this project, taking the method of random, double blindness and control, the placebo group with aMCI will take placebo for three months. After that, cognitive changes will be test.

Placebo group with aMCI

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of patients with aMCI: memory loss complaint confirmed by an informant; objective cognitive impairment in single or multiple domains, adjusted for age and education; preserved general cognitive function; failure to meet the criteria for dementia; the clinical dementia rating (CDR) score is 0.5.
• Clinical diagnosis of patients with subjective cognitive decline (SCD): presence of self-perceived continuous cognitive decline compared to previous normal status and unrelated to an acute event; failure to meet the following criteria for MCI.
• Clinical diagnosis of the control group: no complaint of memory loss; CDR score is 0; no severe visual or auditory impairment.

You may not qualify if:

• a history of stroke;
• major depression (Hamilton Depression Rating Scale score \> 24 points);
• other central nervous system diseases that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis and epilepsy;
• cognitive impairment caused by traumatic brain injury;
• systemic diseases, such as thyroid dysfunction, syphilis and HIV;
• a history of psychosis or congenital mental growth retardation.

Sponsors & Collaborators

• XuanwuH 2: lead
• First Hospital of Tsinghua University: collaborator
• Beijing Normal University: collaborator

Study Sites (1)

Department of Neurolgy, Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Ying Han, PhD

  Xuanwu Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2019
• First Posted: June 19, 2019
• Study Start: August 31, 2019
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: When summary data are published or starting 6 months after publication.
• Access Criteria: The information of neuropsychological tests, neuroimaging data will be shared.

Locations

CN (1)