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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A02246-47 | Other Identifier | ANSM |
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Despite an extension of the planned duration of inclusion and an enrolled patient number inferior than planned, coordinating investigator considered that it was more reasonable to stop inclusions in order to analyze the data already available
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alzheimer with rapid DCR | Experimental |
| |
| Alzheimer without rapid DCR | Experimental |
| |
| Control | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal sample collection | Procedure | Fecal sample collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
For Alzheimer groups without DCR and Alzheimer with DCR:
For the control group (non-Alzheimer's)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Angers | Angers | 49000 | France | |||
| CHU de Nantes |
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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.
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| 1 year |
| Nantes |
| 44000 |
| France |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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