Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults

Not Applicable

Active, not recruiting

• Conditions: Frail Elderly
• Interventions: Procedure: MRI and PET scan

• Registration Number: NCT03129269
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2017-01-02
• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-12
• Primary Completion: 2026-01-02
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

• Female and male individuals referred to the Toulouse Frailty Clinic with an objective memory impairment (CDR=0.5 or CDR=1)
• Age ≥ 70 years
• At least 1 Fried-criterion
• Informed consent signed by the patient
• Having an informant accompanying or available by phone
• Individuals affiliated to a healthcare scheme.
• • Willing to be informed in case of a new pathology discovered through medical examination

Extension study (Cog-Frail Plus):

• COGFRAIL study participants still included in the study and completing their last visit (M 24)
• Having a family member or legal representant to sign the consent form if MMSE score <20 at the last visit (M24)

Exclusion Criteria

• Individuals presenting severe visual or auditory difficulties which may interfere with the completion of neuropsychological and functional assessments.
• Presence of any pathology or severe clinical or psychological condition that, according to the investigator, might interfere with study results or may expose the participants to additional risks.
• Individuals who are robust according to the Fried criteria (0 criteria)
• Individuals who are dependent (Activities of Daily Living (ADL) <4)
• Individuals who have a major deterioration in global cognitive function (Mini Mental State Examination (MMSE) <20)
• Subjects deprived of their liberty by administrative or judicial decision, or under guardianship or admitted to a healthcare or social institution (subjects in non-assisted living facilities could be recruited);

Exclusion criteria for MRI scanning :

• Claustrophobia
• Trauma or surgery which may have left ferromagnetic material in the body, including pacemakers
• History of neurosurgery or aneurism

Extension study (Cog-Frail Plus):

• Presence of any severe pathology that, according to the investigator, might interfere with study results or may expose the participants to additional risks.
• Subjects deprived of their liberty by administrative or judicial decision, or under guardianship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neuroimaging amyloid diagnosis by MRI and PET scan	MRI and PET scan	There is only one arm. The procedure consists in neuroimaging to diagnose the presence of amyloid plaques in the brains and permit earlier detection of Alzheimer's disease. MRI and PET Scan. * Visits at baseline, 1 and 2 years for a full neuropsychological, functional and physical evaluation. * At 6 and 18 months in consultation by a Geriatrician and research assistant for a medical check. * one PET-Scan in the 2 months following inclusion for amyloid measurements and one MRI, depending on the clinical relevance * A blood sample for biobank at visit 2 and at visit 5. Extension study (CogFrail-Plus): additional 2 years follow-up of the COGFRAIL study participants, following the initial 2 years period of the study: * 2 Visits at at 36 and 48 months for a full neuropsychological, functional and physical evaluation * At 30 and 42 months in consultation by a Geriatrician and research assistant for a medical check * A blood sample at 36 and 48 months.

Primary Outcome Measures

Name	Time	Method
Amyloid physiological parameter	2 months after inclusion	Amyloid pathology as corroborated with amyloid Positron Emission Tomography (PET) or lumbar punction

Secondary Outcome Measures

Name	Time	Method
Changes in functional capacities with scales ADL	12 and 24 months	Changes in functional capacities, body composition, frailty phenotype, dietary intake and nutritional status with Instrumental Activities of Daily Living (IADL), Activities of Daily Living (ADL), Short Physical Performance Battery (SPPB).; All measures analysed together, parameters are linked and must be evaluated all together to get the main information.
Changes in functional capacities with scales SPPB	12 and 24 months	Changes in functional capacities, body composition, frailty phenotype, dietary intake and nutritional status with Instrumental Activities of Daily Living (IADL), Activities of Daily Living (ADL), Short Physical Performance Battery (SPPB).; All measures analysed together, parameters are linked and must be evaluated all together to get the main information.
Change in cognitive function with Clinical Dementia Rating Scale (CDR)	12 and 24 months	Comparison between 2 timeframe to observe change in cognitive function between T12, T24 months
Changes in functional capacities with scales IADL	12 and 24 months	Changes in functional capacities, body composition, frailty phenotype, dietary intake and nutritional status with Instrumental Activities of Daily Living (IADL), Activities of Daily Living (ADL), Short Physical Performance Battery (SPPB).; All measures analysed together, parameters are linked and must be evaluated all together to get the main information.

Trial Locations

Locations (1)

Toulouse University Hospital (CHU de Toulouse); 🇫🇷 Toulouse, France