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

Nantes University Hospital (NUH)

Status: Terminated

Conditions: Alzheimer Disease; Intestinal Microbiota

Treatments: Procedure: Fecal sample collection

Study type: Interventional

Funder types: Other

Identifiers

NCT03487380

RC17_0162

2017-A02246-47 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 86 patients

Sex: All

Ages: 70 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 3 patient groups

Alzheimer with rapid DCR

Experimental group

Treatment:

Procedure: Fecal sample collection

Alzheimer without rapid DCR

Experimental group

Treatment:

Procedure: Fecal sample collection

Control

Sham Comparator group

Treatment:

Procedure: Fecal sample collection