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Register:	ClinicalTrials.gov
Last refreshed on:	12 February 2024
Main ID:	NCT03487380
Date of registration:	27/03/2018
Prospective Registration:	No
Primary sponsor:	Nantes University Hospital
Public title:	Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease MiDCR
Scientific title:	Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
Date of first enrolment:	September 4, 2017
Target sample size:	86
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/ct2/show/NCT03487380
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
France

Contacts

Key inclusion & exclusion 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

Age minimum: 70 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Alzheimer Disease

Intestinal Microbiota

Intervention(s)

Procedure: Fecal sample collection

Primary Outcome(s)

analysis of the taxonomic and functional composition of the microbiome [Time Frame: 1 year]

Secondary Outcome(s)

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]

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]

Secondary ID(s)

2017-A02246-47

RC17_0162

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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