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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03487380
Acronym
MiDCR
Enrollment
86
Registered
2018-04-04
Start date
2017-09-04
Completion date
2023-06-12
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Intestinal Microbiota

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

Interventions

Fecal sample collection

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
70 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
analysis of the taxonomic and functional composition of the microbiome1 year(shotgun sequencing), in patients with DCR (loss of at least 3 points in the MMSE at 1 year.

Secondary

MeasureTime frame
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 analysis1 year
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026