NCT05943925

Brief Summary

Dementia is the major cause of disability and dependency among older adults worldwide affecting memory, cognitive abilities and behavior, interfering with one's ability to perform daily lives activities. Although age is the strongest known risk factor for the onset of dementia, it is not a natural or inevitable consequence of aging. Dementia not only affects older people, since up to 9% of the cases appear before 65 years. The impact of dementia is highly important in financial terms also in human costs to countries, societies and individuals. Dementia is an umbrella term for several diseases, being Alzheimer's disease (AD) the most common form, contributing to 60-70% of cases. Other major forms include Lewy bodies Dementias (LBDs) and frontotemporal dementia (FTD). The role of the gastrointestinal microbiota in human brain development and function is an area of increasing interest and research. A large number of studies suggest that the gut microbiota can influence the brain, cognition and behavior of the patients, and also modulate brain plasticity, modifying brain chemistry via various mechanisms like neural, immune and endocrine Within these last two years some studies have showed differences in the microbiota of the AD patients from healthy controls. In this sense, increasing number of studies, most of them in animal models, support the notion that probiotics have significant benefit in maintaining homeostasis of the Central Nervous System. And recent studies try to replicate this finding in AD patients with controversial results. The main objective of DEM-BIOTA project is to improve the knowledge of the relationship between microbiota and dementia. DEM-BIOTA will explore the microbiota differences between dementias: AD, LBDs, that includes: Parkinson disease dementia (PDD) and Lewy Body Dementia (LBD) and FTD-behavioral variant, also in Mild Cognitive Impairment (MCI) to study the progression; in our context (Mediterranean diet and lifestyle) and characterize them in relation to neurocognitive and neuropsychiatric symptoms as well as patient functionality (dependency level). Moreover, the capacity of a probiotic compound in reverting or improving neurocognitive and neuropsychiatric symptoms and patient functionality in a sample of AD patients will be also studied.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 16, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

July 13, 2023

Status Verified

June 1, 2023

Enrollment Period

3.8 years

First QC Date

April 26, 2023

Last Update Submit

July 12, 2023

Conditions

Keywords

cognitive statusfunctional statusneuropsychiatric statusmicrobiota

Outcome Measures

Primary Outcomes (18)

  • Shotgun sequencing metagenomics analysis (NextSeq2000)

    Gut microbiome was analysed using a shotgun metagenomic approach. DNA was extracted from samples using the DNA Preparation with Tagmentation kit, according to manufacturer protocols (Illumina, California, USA, catalog no. 20018705). Sequencing libraries concentration was determined by Qubit 4.0 fluorometer and Qubit dsDNA High Sensivity Assay Kit (Thermo Fisher Scientific, Massachusetts, USA). Sequencing libraries length was checked by Agilent TapeStation and Agilent High Sensitivity DNA kit (Agilent Technologies, California, USA). Sequencing libraries with concentration below 750 per Molar and length out of 400-600 bp range were discarded. Final sequencing libraries were mixed at 750 bp and sequenced using the NextSeq 2000 sequencing system (Illumina, California, USA) as 2x150-bp paired-end reads. Samples below 7,5 million reads were discarded. Shotgun metagenomic reads were profiled for microbial species relative abundances by mapping them to several databases with Kraken2.

    Baseline for all the group subjects subjects in microbiota composition study. Baseline, change from baseline at 12 weeks and change from baseline at 24 weeks for Alzheimer Disease (AD) patients in the probiotic study.

  • Neuropsychology assessment: Mini Mental State Examination (MMSE)

    Mini Mental State Examination (MMSE), screening test for cognitive deterioration. At Baseline for no intervention study, study 1. For the probiotic study, study 2, at baseline, change at 12 weeks and change at 24 weeks

    Baseline for all the group subjects subjects in microbiota composition study. Baseline, change from baseline at 12 weeks and change from baseline at 24 weeks for AD patients in the probiotic study.

  • Neuropsychology assessment: Global Deterioration Scale-Functional Assessment Staging (GDS-FAST)

    Global Deterioration Scale-Functional Assessment Staging (GDS-FAST) At Baseline for no intervention study, study 1. For the probiotic study, study 2, at baseline, change from baseline at 12 weeks and change from baseline at 24 weeks.

    Baseline for all the group subjects subjects in microbiota composition study. Baseline, change from baseline at 12 weeks and change from baseline at 24 weeks for AD patients in the probiotic study.

  • Neuropsychology assessment: Clinical Dementia Rating (CDR)

    Clinical Dementia Rating (CDR) score. At Baseline for no intervention study, study 1. For the probiotic study, study 2, at baseline, change from the baseline at 12 weeks and change from baseline at 24 weeks.

    Baseline for all the group subjects subjects in microbiota composition study. Baseline, change from baseline at 12 weeks and change from baseline at 24 weeks for AD patients in the probiotic study.

  • Neuropsychology assessment: Memory Impairment Screen (MIS)

    Memory Impairment Screen (MIS). Screening test for memory impairment. At Baseline for no intervention study, study 1.

    Baseline for all the group subjects subjects in microbiota composition study.

  • Neuropsychology assessment: Categorical Recall Test (Barcelona-2 Test)

    Categorical Recall Test (Barcelona-2 Test), semantic and phonemic fluency tests At Baseline for no intervention study, study 1.

    Baseline for all the group subjects subjects in microbiota composition study.

  • Neuropsychology assessment: Orientation

    Orientation in Time, Space and Person (Barcelona-2 Test) At Baseline for no intervention study, study 1.

    Baseline for all the group subjects subjects in microbiota composition study.

  • Neuropsychology assessment: Free and Cue Selective Reminding Test (FCSRT)

    Free and Cue Selective Reminding Test (FCSRT). Long and short Memory assessment test. At Baseline for no intervention study, study 1.

    Baseline for all the group subjects subjects in microbiota composition study.

  • Neuropsychology assessment: Trial Making Test (TMT) A and B

    TMT A and B. Measures visuospatial, attention and executive functions. At Baseline for no intervention study, study 1.

    Baseline for all the group subjects subjects in microbiota composition study.

  • Neuropsychology assessment: Boston Abbreviated Naming Test

    Boston Abbreviated Naming Test At Baseline for no intervention study, study 1.

    Baseline for all the group subjects subjects in microbiota composition study.

  • Neuropsychology assessment: Verbal span

    Verbal Span (Barcelona-2 Test), that assesses attentional span and control/working memory. At Baseline for no intervention study, study 1.

    Baseline for all the group subjects subjects in microbiota composition study.

  • Neuropsychology assessment: Clock test

    Clock Test, screening test for detecting cognitive impairment At Baseline for no intervention study, study 1.

    Baseline for all the group subjects subjects in microbiota composition study.

  • Neuropsychology assessment: Frontal Assessment Battery (FAB)

    Frontal Assessment Battery (FAB), that assesses impairments related to frontal lobe function. At Baseline for no intervention study, study 1.

    Baseline for all the group subjects subjects in microbiota composition study.

  • Neuropsychology assessment: Simple and semi complex constructive praxis (Barcelona-2 Test)

    Simple and semi complex constructive praxis (Barcelona-2 Test) At Baseline for no intervention study, study 1.

    Baseline for all the group subjects subjects in microbiota composition study.

  • Neuropsychology assessment: Abbreviated Barcelona-2 Test

    Abbreviated Barcelona-2 Test. Abbreviated neuropsychological battery already normalised in Spanish populations. Only for the probiotic study, study 2, at baseline, change from baseline at 12 weeks and change from baseline at 24 weeks.

    Baseline, change from baseline at 12 weeks and change from baseline at 24 weeks for AD patients in the probiotic study.

  • Neuropsychiatric assessment: Golberg Anxiety and Depression Scale

    Golberg Anxiety and Depression Scale (more punctuation, more anxiety or depression symptoms) At Baseline for no intervention study For the probiotic study: At baseline, change from baseline at 12 weeks and change from baseline at 24 weeks.

    Baseline for all the group subjects subjects in microbiota composition study. Baseline, change from baseline at 12 weeks and change from baseline at 24 weeks for AD patients in the probiotic study.

  • Neuropsychiatric assessment: Neuropsychiatric Symptoms (Barcelona-2 Test)

    For microbiota composition study, the following tests will be assessed: Neuropsychiatric Symptoms (Barcelona-2 Test), (more punctuation, more neuropsychiatric symptoms) At Baseline for no intervention study For the probiotic study: At baseline, change from baseline at 12 weeks and change from baseline 24 weeks.

    Baseline for all the group subjects subjects in microbiota composition study. Baseline, change from baseline at 12 weeks and change from baseline at 24 weeks for AD patients in the probiotic study.

  • Functional assessment

    For microbiota composition study, the following tests will be assessed: Activities of Daily Living (ADL) (Barcelona-2 Test), (more punctuation, more dependent; punctuation total scale 0-100, Instrumental activities 0-60 + Basic activities 0-40) At Baseline for no intervention study For the probiotic study: At baseline, change from baseline at 12 weeks and change from baseline at 24 weeks, the following tests will be assessed: Activities of Daily Living ADL (Barcelona-2 Test), (more punctuation, more dependent; punctuation total scale 0-100, Instrumental activities 0-60 + Basic activities 0-40)

    Baseline for all the group subjects subjects in microbiota composition study. Baseline, change from baseline at 12 weeks and change from baseline at 24 weeks for AD patients in the probiotic study.

Secondary Outcomes (3)

  • Assessment of stress events

    Baseline for all the group subjects subjects in microbiota composition study. Baseline, change from baseline at 12 weeks and change from baseline at 24 weeks for AD patients in the probiotic study.

  • Mediterranean lifestyle assessment

    Baseline for all the group subjects subjects in microbiota composition study. Baseline, change from baseline at 12 weeks and change from baseline at 24 weeks for AD patients in the probiotic study.

  • Cognitive reserve assessment

    Baseline for all the group subjects subjects in microbiota composition study. Baseline, change from baseline at 12 weeks and change from baseline at 24 weeks for AD patients in the probiotic study.

Study Arms (8)

Healthy control group

The criteria for the recruitment will be: Inclusion criteria: more than 60 years. Exclusion criteria: Significant neurology disease diagnosed, infectious treatment with antibiotics in the previous 6 months prior to providing the stool sample, corticosteroid use, immunosuppressors or immunostimulants treatment, illnesses of the gastrointestinal (GI) tract, large doses of commercial probiotics consumed (greater than or equal to 108 colony forming units (cfu) per organisms per day). This control group were recruited from relatives of the patients enrolled or general population and interviewed at the hospital (relatives, University or their homes). Neuropsychological, functional and neuropsychiatric assessment and stool sample.

Other: No intervention

Alzheimer Disease (AD)

The criteria for the recruitment will be: Inclusion criteria: Alzheimer Disease (AD) diagnosed by the neurology service; more than 60 years. Exclusion criteria: Comorbidity with other significant neurology disease, infectious treatment with antibiotics in the previous 6 months prior to providing the stool sample, corticosteroid use, immunosuppressors or immunostimulants treatment, illnesses of the GI tract, large doses of commercial probiotics consumed (greater than or equal to 108 colony forming units (cfu) per organisms per day). Neuropsychological, functional and neuropsychiatric assessment and stool sample.

Other: No intervention

Mild Cognitive Impairment (MCI)- amnesic

The criteria for the recruitment will be: Inclusion criteria: Mild Cognitive Impairment (MCI) amnesic, diagnosed by the neurology service; more than 60 years. Exclusion criteria: Comorbidity with other significant neurology disease, infectious treatment with antibiotics in the previous 6 months prior to providing the stool sample, corticosteroid use, immunosuppressors or immunostimulants treatment, illnesses of the gastrointestinal (GI) tract, large doses of commercial probiotics consumed (greater than or equal to 108 colony forming units (cfu) per organisms per day). Neuropsychological, functional and neuropsychiatric assessment and stool sample.

Other: No intervention

Parkinson Disease Dementia (PDD)

The criteria for the recruitment will be: Inclusion criteria: Parkinson Disease Dementia (PDD) diagnosed by the neurology service; more than 60 years. Exclusion criteria: Comorbidity with other significant neurology disease, infectious treatment with antibiotics in the previous 6 months prior to providing the stool sample, corticosteroid use, immunosuppressors or immunostimulants treatment, illnesses of the gastrointestinal (GI) tract, large doses of commercial probiotics consumed (greater than or equal to 108 colony forming units (cfu) per organisms per day). Neuropsychological, functional and neuropsychiatric assessment and stool sample.

Other: No intervention

Lewy bodies dementia (LBD)

The criteria for the recruitment will be: Inclusion criteria: Lewy Body Dementia (LBD) diagnosed by the neurology service; more than 60 years. Exclusion criteria: Comorbidity with other significant neurology disease, infectious treatment with antibiotics in the previous 6 months prior to providing the stool sample, corticosteroid use, immunosuppressors or immunostimulants treatment, illnesses of the gastrointestinal (GI) tract, large doses of commercial probiotics consumed (greater than or equal to 108 colony forming units (cfu) per organisms per day). Neuropsychological, functional and neuropsychiatric assessment and stool sample.

Other: No intervention

Frontotemporal Dementia (FTD)-behavioral variant

The criteria for the recruitment will be: Inclusion criteria: Frontotemporal Dementia (FTD)-behavioral variant diagnosed by the neurology service; more than 60 years. Exclusion criteria: Comorbidity with other significant neurology disease, infectious treatment with antibiotics in the previous 6 months prior to providing the stool sample, corticosteroid use, immunosuppressors or immunostimulants treatment, illnesses of the gastrointestinal (GI) tract, large doses of commercial probiotics consumed (greater than or equal to 108 colony forming units (cfu) per organisms per day). Neuropsychological, functional and neuropsychiatric assessment and stool sample.

Other: No intervention

Alzheimer disease (AD)-control

Inclusion criteria: Alzheimer Disease (AD) diagnosed by the neurology service; more than 65 years. Exclusion criteria: Comorbidity with other significant neurology disease, infectious treatment with antibiotics in the previous 6 months prior to providing the stool sample, corticosteroid use, immunosuppressors or immunostimulants treatment, illnesses of the gastrointestinal (GI) tract, large doses of commercial probiotics consumed (greater than or equal to 108 colony forming units (cfu) per organisms per day). Neuropsychological, functional and neuropsychiatric assessment and stool sample at basal, 12 weeks and 24 weeks.

Dietary Supplement: Probiotic supplement

Alzheimer disease (AD)-probiotic

Inclusion criteria: Alzheimer Disease (AD) diagnosed by the neurology service; more than 65 years. Exclusion criteria: Comorbidity with other significant neurology disease, infectious treatment with antibiotics in the previous 6 months prior to providing the stool sample, corticosteroid use, immunosuppressors or immunostimulants treatment, illnesses of the gastrointestinal (GI) tract, large doses of commercial probiotics consumed (greater than or equal to 108 colony forming units (cfu) per organisms per day). Neuropsychological, functional and neuropsychiatric assessment and stool sample at basal, 12 weeks and 24 weeks.

Dietary Supplement: Probiotic supplement

Interventions

no intervention

Alzheimer Disease (AD)Frontotemporal Dementia (FTD)-behavioral variantHealthy control groupLewy bodies dementia (LBD)Mild Cognitive Impairment (MCI)- amnesicParkinson Disease Dementia (PDD)
Probiotic supplementDIETARY_SUPPLEMENT

A total of 60 Alzheimer Disease (AD) patients will be recruited, 30 will ingest the probiotic mixture and 30 will ingest placebo (randomized assignment to the groups will be done). The experimental group will take the probiotic ingest daily: Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium bifidum, and Lactobacillus fermentum (2 × 109 colony forming units (CFU)/g of each). This mixture of bacteria has been showed to have positive results with 12 weeks treatment.

Alzheimer disease (AD)-controlAlzheimer disease (AD)-probiotic

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinic patients from hospitals and other diagnostic medical centers.

You may qualify if:

  • Study 1, microbiota composition study- AD, PD, LBD, FTD-behavioral variant or MCI-amnesic
  • diagnosed by the neurology service (or healthy subjects, without any of these diagnostics).
  • more than 60 years
  • Study 2-probiotic intervention,:
  • AD diagnosed by the neurology service;
  • more than 65 years.

You may not qualify if:

  • Study 1, microbiota study:
  • Comorbidity with other significant neurology disease,
  • Infectious treatment with antibiotics in the previous 6 months prior to providing the stool sample,
  • corticosteroid use,
  • immunosuppressors or immunostimulants treatment,
  • illnesses of the Gastro Intestinal tract,
  • large doses of commercial probiotics consumed (greater than or equal to 10 elevated to 8 colony forming unit per organisms per day).
  • Study 2-probiotic intervention:
  • Comorbidity with other significant neurology disease,
  • Infectious treatment with antibiotics in the previous 6 months prior to providing the stool sample,
  • corticosteroid use,
  • immunosuppressors or immunostimulants treatment,
  • illnesses of the GI tract,
  • large doses of commercial probiotics consumed (greater than or equal to 10 elevated to 8 cfu per organisms per day).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Margarita Torrente

Tarragona, 43007, Spain

RECRUITING

Related Publications (23)

  • Cabrera C, Vicens P, Torrente M. Modifiable Risk Factors for Dementia: The Role of Gut Microbiota. Curr Alzheimer Res. 2021;18(13):993-1009. doi: 10.2174/1567205018666211215152411.

    PMID: 34911422BACKGROUND
  • Agahi A, Hamidi GA, Daneshvar R, Hamdieh M, Soheili M, Alinaghipour A, Esmaeili Taba SM, Salami M. Does Severity of Alzheimer's Disease Contribute to Its Responsiveness to Modifying Gut Microbiota? A Double Blind Clinical Trial. Front Neurol. 2018 Aug 15;9:662. doi: 10.3389/fneur.2018.00662. eCollection 2018.

    PMID: 30158897BACKGROUND
  • Akbari E, Asemi Z, Daneshvar Kakhaki R, Bahmani F, Kouchaki E, Tamtaji OR, Hamidi GA, Salami M. Effect of Probiotic Supplementation on Cognitive Function and Metabolic Status in Alzheimer's Disease: A Randomized, Double-Blind and Controlled Trial. Front Aging Neurosci. 2016 Nov 10;8:256. doi: 10.3389/fnagi.2016.00256. eCollection 2016.

    PMID: 27891089BACKGROUND
  • Benton D, Williams C, Brown A. Impact of consuming a milk drink containing a probiotic on mood and cognition. Eur J Clin Nutr. 2007 Mar;61(3):355-61. doi: 10.1038/sj.ejcn.1602546. Epub 2006 Dec 6.

    PMID: 17151594BACKGROUND
  • Davari S, Talaei SA, Alaei H, Salami M. Probiotics treatment improves diabetes-induced impairment of synaptic activity and cognitive function: behavioral and electrophysiological proofs for microbiome-gut-brain axis. Neuroscience. 2013 Jun 14;240:287-96. doi: 10.1016/j.neuroscience.2013.02.055. Epub 2013 Mar 7.

    PMID: 23500100BACKGROUND
  • Kelly JR, Allen AP, Temko A, Hutch W, Kennedy PJ, Farid N, Murphy E, Boylan G, Bienenstock J, Cryan JF, Clarke G, Dinan TG. Lost in translation? The potential psychobiotic Lactobacillus rhamnosus (JB-1) fails to modulate stress or cognitive performance in healthy male subjects. Brain Behav Immun. 2017 Mar;61:50-59. doi: 10.1016/j.bbi.2016.11.018. Epub 2016 Nov 16.

    PMID: 27865949BACKGROUND
  • Messaoudi M, Lalonde R, Violle N, Javelot H, Desor D, Nejdi A, Bisson JF, Rougeot C, Pichelin M, Cazaubiel M, Cazaubiel JM. Assessment of psychotropic-like properties of a probiotic formulation (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) in rats and human subjects. Br J Nutr. 2011 Mar;105(5):755-64. doi: 10.1017/S0007114510004319. Epub 2010 Oct 26.

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  • Saji N, Niida S, Murotani K, Hisada T, Tsuduki T, Sugimoto T, Kimura A, Toba K, Sakurai T. Analysis of the relationship between the gut microbiome and dementia: a cross-sectional study conducted in Japan. Sci Rep. 2019 Jan 30;9(1):1008. doi: 10.1038/s41598-018-38218-7.

    PMID: 30700769BACKGROUND
  • Tillisch K, Labus J, Kilpatrick L, Jiang Z, Stains J, Ebrat B, Guyonnet D, Legrain-Raspaud S, Trotin B, Naliboff B, Mayer EA. Consumption of fermented milk product with probiotic modulates brain activity. Gastroenterology. 2013 Jun;144(7):1394-401, 1401.e1-4. doi: 10.1053/j.gastro.2013.02.043. Epub 2013 Mar 6.

    PMID: 23474283BACKGROUND
  • Vogt NM, Kerby RL, Dill-McFarland KA, Harding SJ, Merluzzi AP, Johnson SC, Carlsson CM, Asthana S, Zetterberg H, Blennow K, Bendlin BB, Rey FE. Gut microbiome alterations in Alzheimer's disease. Sci Rep. 2017 Oct 19;7(1):13537. doi: 10.1038/s41598-017-13601-y.

    PMID: 29051531BACKGROUND
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    PMID: 34474192BACKGROUND
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    PMID: 6501581BACKGROUND
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    PMID: 11113214BACKGROUND
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Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

stool sample

MeSH Terms

Conditions

Alzheimer DiseaseLewy Body DiseasePick Disease of the BrainCognitive Dysfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesFrontotemporal DementiaFrontotemporal Lobar DegenerationCognition Disorders

Study Officials

  • Margarita Torrente, Dr

    University Rovira i Virgili

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Margarita Torrente, Dr

CONTACT

David Mateo, Predoc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 26, 2023

First Posted

July 13, 2023

Study Start

April 16, 2021

Primary Completion

January 31, 2025

Study Completion

February 1, 2025

Last Updated

July 13, 2023

Record last verified: 2023-06

Locations