Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481878
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-05-31
Brief Title:
Validation of an Alzheimers Disease Marker by Fecal Assay of Amyloid Peptides and Tau Proteins
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Validation of a Diagnostic Andor Prognostic Marker for Alzheimers Disease by Fecal Determination of Amyloid Peptides and Tau Proteins
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FecAlz
Brief Summary:
Alzheimers disease AD is the leading cause of dementia in humans currently affecting almost one million people in France It results from an irreversible degeneration of neurons responsible for a progressive decline in the main cognitive and memory functions due to a cerebral accumulation of plaques containing fibrillary amyloid peptide Aβ and neurofibrillary tangles composed of truncated hyperphosphorylated tau protein pTau
There is currently no curative treatment for this disease in France However two treatments aimed at reducing beta-amyloid plaques in the brain have been approved by the US Food and Drug Administration The failure of the latest therapeutic strategies is largely due to the fact that the disease is diagnosed too late starting with a long asymptomatic phase which is the one that needs to be targeted in order to prevent irreversible neurodegenerative mechanisms
The development of diagnostic tools is gradually making it possible to detect such a sequence but this has its drawbacks radioactive load invasive procedure cumbersome set-up
Over the last ten years research has focused on the development of plasma or salivary markers Although encouraging these studies show either a lack of sensitivity or reproducibility or a lack of specificity or precocity
The expression of Aβ and Tau proteins has recently been demonstrated in the enteric nervous system and enterocytes Intestinal Aβ is involved in various gut functions and regulation
What recent work by investigators demonstrates is the essential and hitherto unrecognized role of the gut-brain axis in maintaining brain homeostasis In a mouse model of AD the investigators have demonstrated a mechanism for intestinal elimination clearance of toxic brain forms of Tau and Aβ proteins via the lymphatic network
The clearance of cerebral Tau and Aβ proteins in the stool may constitute a reliable and powerful diagnostic signature of AD Its study would represent a new non-invasive and easily accessible technique for the early diagnosis of AD in humans
There is currently no curative treatment for this disease in France However two treatments aimed at reducing beta-amyloid plaques in the brain have been approved by the US Food and Drug Administration The failure of the latest therapeutic strategies is largely due to the fact that the disease is diagnosed too late starting with a long asymptomatic phase which is the one that needs to be targeted in order to prevent irreversible neurodegenerative mechanisms
The development of diagnostic tools is gradually making it possible to detect such a sequence but this has its drawbacks radioactive load invasive procedure cumbersome set-up
Over the last ten years research has focused on the development of plasma or salivary markers Although encouraging these studies show either a lack of sensitivity or reproducibility or a lack of specificity or precocity
The expression of Aβ and Tau proteins has recently been demonstrated in the enteric nervous system and enterocytes Intestinal Aβ is involved in various gut functions and regulation
What recent work by investigators demonstrates is the essential and hitherto unrecognized role of the gut-brain axis in maintaining brain homeostasis In a mouse model of AD the investigators have demonstrated a mechanism for intestinal elimination clearance of toxic brain forms of Tau and Aβ proteins via the lymphatic network
The clearance of cerebral Tau and Aβ proteins in the stool may constitute a reliable and powerful diagnostic signature of AD Its study would represent a new non-invasive and easily accessible technique for the early diagnosis of AD in humans
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-A00378-39 | OTHER | None | None |