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

Toulouse University Hospital

Status: Active, not recruiting

Conditions: Frail Elderly

Treatments: Procedure: MRI and PET scan

Study type: Interventional

Funder types: Other

Identifiers

NCT03129269

RC31/16/8753

Details and patient eligibility

About

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.

Full 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.

Enrollment: 345 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No 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

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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345 participants in 1 patient group

neuroimaging amyloid diagnosis by MRI and PET scan

Experimental group

Description:

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.

Treatment:

Procedure: MRI and PET scan