COGFRAIL: Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Recruiting

CT.gov ID

NCT03129269

Collaborator

MSDAVENIR (Other)

345

Enrollment

Location

Arm

119.9

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Frail Elderly	Procedure: MRI and PET scan	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

345 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults

Actual Study Start Date :

Jan 2, 2017

Anticipated Primary Completion Date :

Jan 2, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: neuroimaging amyloid diagnosis by 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 will be scheduled at baseline, 1 and 2 years for a full neuropsychological, functional and physical evaluation. In addition, 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 (visit 5).	Procedure: MRI and PET scan Neuroimaging with MRI and PET scan Amyloid tracer : For PET-scans, 4 MBq/kg of [18F]AV-45 will be injected into each subject in an intravenous bolus.

Arm

Intervention/Treatment

Experimental: neuroimaging amyloid diagnosis by 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 will be scheduled at baseline, 1 and 2 years for a full neuropsychological, functional and physical evaluation. In addition, 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 (visit 5).

Procedure: MRI and PET scan

Neuroimaging with MRI and PET scan Amyloid tracer : For PET-scans, 4 MBq/kg of [18F]AV-45 will be injected into each subject in an intravenous bolus.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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);