Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-03 @ 10:20 PM
Study NCT ID:
NCT03129269
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2017-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults
Sponsor:
University Hospital, Toulouse
Organization:
Study Overview
Official Title:
Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
COGFRAIL
Brief Summary:
The current study seeks to examine the prevalence of amyloid pathology, among patients referred to the Toulouse Geriatric Frailty Clinic presenting objective memory impairment. We also aim to fully characterize the clinical progression of frail cognitively impaired patients presenting AD (Alzheimer Disease) pathology vs those who also present a cognitive impairment but do not have AD pathology.
Detailed Description:
The COGFRAIL study is a monocentric study integrating the longitudinal follow-up of 345 individuals referred to the Toulouse Frailty Clinic during 2 years. The procedure consists in neuroimaging to diagnose the presence of amyloid plaques in the brains and permit earlier detection of Alzheimer's disease.
* Visits will be scheduled at baseline, 1 and 2 years for a full neuropsychological, functional and physical evaluation.
* At 6 and 18 months patients will be seen in consultation by a Geriatrician and research assistant for a medical check.
* PET-Scan will be scheduled in the 2 months following inclusion for amyloid measurements. The MRI will be proposed, depending on the clinical relevance
* A blood sample for biobank will be taken at visit 2 and at the end of the study
Extension study (CogFrail-Plus):
The extension study will integrate an additional 2 years follow-up of the
COGFRAIL study participants, following the initial 2 years period of the study:
* 2 Visits will be scheduled at 36 and 48 months for a full neuropsychological, functional and physical evaluation
* At 30 and 42 months patients will be seen in consultation by a Geriatrician and research assistant for a medical check
* A blood sample will be taken at 36 and 48 months.
* Visits will be scheduled at baseline, 1 and 2 years for a full neuropsychological, functional and physical evaluation.
* At 6 and 18 months patients will be seen in consultation by a Geriatrician and research assistant for a medical check.
* PET-Scan will be scheduled in the 2 months following inclusion for amyloid measurements. The MRI will be proposed, depending on the clinical relevance
* A blood sample for biobank will be taken at visit 2 and at the end of the study
Extension study (CogFrail-Plus):
The extension study will integrate an additional 2 years follow-up of the
COGFRAIL study participants, following the initial 2 years period of the study:
* 2 Visits will be scheduled at 36 and 48 months for a full neuropsychological, functional and physical evaluation
* At 30 and 42 months patients will be seen in consultation by a Geriatrician and research assistant for a medical check
* A blood sample will be taken at 36 and 48 months.
Study Oversight
Has Oversight DMC:
False
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?: