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

NCT03487380 | Terminated

• 2 other identifiers: RC17_01622017-A02246-47
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

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

Conditions

Alzheimer Disease; Intestinal Microbiota

Outcome Measures

Primary Outcomes (1)

• analysis of the taxonomic and functional composition of the microbiome

  ("shotgun sequencing"), in patients with DCR (loss of at least 3 points in the MMSE at 1 year.

  1 year

Secondary Outcomes (2)

• 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.

  Day 0

• 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

  1 year

Study Arms (3)

Alzheimer with rapid DCR

EXPERIMENTAL

Procedure: Fecal sample collection

Alzheimer without rapid DCR

EXPERIMENTAL

Procedure: Fecal sample collection

Control

SHAM COMPARATOR

Procedure: Fecal sample collection

Interventions

Fecal sample collection PROCEDURE

Fecal sample collection

Alzheimer with rapid DCR; Alzheimer without rapid DCR; Control

Eligibility Criteria

• Age: 70 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

CHU de Angers

Angers, 49000, France

Location

CHU de Nantes

Nantes, 44000, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 4, 2018
• Study Start: September 4, 2017
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

FR (2)