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Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease (MiDCR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03487380
Recruitment Status : Unknown
Verified April 2019 by Nantes University Hospital.
Recruitment status was:  Recruiting
First Posted : April 4, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
The objective of the study is to highlight a modification of the composition of the intestinal microbiota associated with the diagnosis of Alzheimer's disease and its most unfavorable form, Rapid Cognitive Decline (DCR). This identification could lead to diagnostic strategies based on the analysis of the intestinal microbiome, and preventive and curative treatments, based on the modulation of intestinal microbiota

Condition or disease Intervention/treatment Phase
Alzheimer Disease Intestinal Microbiota Procedure: Fecal sample collection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will compare three groups of 100 patients, corresponding to 200 patients with Alzheimer disease (whom 100 patients in the rapid cognitive decline group and 100 patients without rapid cognitive decline) and 100 patients in the control group.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
Actual Study Start Date : September 4, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Alzheimer with rapid DCR Procedure: Fecal sample collection
Fecal sample collection

Experimental: Alzheimer without rapid DCR Procedure: Fecal sample collection
Fecal sample collection

Sham Comparator: Control Procedure: Fecal sample collection
Fecal sample collection




Primary Outcome Measures :
  1. analysis of the taxonomic and functional composition of the microbiome [ Time Frame: 1 year ]
    ("shotgun sequencing"), in patients with DCR (loss of at least 3 points in the MMSE at 1 year.


Secondary Outcome Measures :
  1. to determine if there is a specific modification of the composition of the intestinal microbiota of patients with Alzheimer's disease, compared to control group. [ Time Frame: Day 0 ]
  2. create a prognostic score of DCR based on clinical data, including the responses to the MMSE, BREF and MNA questionnaires, and taking into account the microbiota analysis [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For Alzheimer groups without DCR and Alzheimer with DCR:

  • patients between 70 and 90 years old
  • with mild to moderate Alzheimer's disease (MMSE> 15/30),
  • followed in the CMRR of the University Hospital of Nantes or Angers
  • having given their informed consent

For the control group (non-Alzheimer's)

  • more patients between 70 and 90 years
  • consultant for a subjective memory complaint isolated at the CMRR of Nantes or Angers University Hospital,
  • having given their informed consent

Exclusion Criteria:

  • Major patients under tutorship, curatorship or safeguard of justice
  • Cognitive disorders possibly related to a metabolic or psychiatric cause
  • History of prescription of antibiotic treatment in the last month
  • History of acute gastrointestinal illness in the last month
  • History of hospitalization for an acute medical pathology or for a surgical procedure in the last month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487380


Contacts
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Contact: Laure de Decker, Pr 02 40 16 50 46 laure.dedecker@chu-nantes.fr
Contact: Guillaume Chapelet, Dr guillaume.chapelet@chu-nantes.fr

Locations
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France
CHU de Angers Not yet recruiting
Angers, France, 49000
Contact: Cedric Annweiler, Dr       Annweiler@chu-angers.fr   
CHU de Nantes Recruiting
Nantes, France, 44000
Contact: Laure De Decker, Pr       laure.dedecker@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03487380    
Other Study ID Numbers: RC17_0162
2017-A02246-47 ( Other Identifier: ANSM )
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders