Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults

N/AActive Not RecruitingNCT03129269

University Hospital, Toulouse345 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

345

Conditions

Frail Elderly

Interventions

MRI and PET scanPROCEDURE

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.

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Toulouse University Hospital (CHU de Toulouse)

Toulouse, France

Outcomes

Primary Outcomes

Amyloid physiological parameter

Amyloid pathology as corroborated with amyloid Positron Emission Tomography (PET) or lumbar punction

Time frame: 2 months after inclusion

Secondary Outcomes

Change in cognitive function with Clinical Dementia Rating Scale (CDR)

Comparison between 2 timeframe to observe change in cognitive function between T12, T24 months

Time frame: 12 and 24 months

Changes in functional capacities with scales IADL

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.

Time frame: 12 and 24 months

Changes in functional capacities with scales ADL

Time frame: 12 and 24 months

Changes in functional capacities with scales SPPB

Time frame: 12 and 24 months

Data from ClinicalTrials.gov

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