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Completed

NCT Number: NCT03129269

Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toulouse University Hospital (CHU de Toulouse)

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI and PET scan

Procedure

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.

Primary outcomes

  1. Amyloid physiological parameter

    Time frame: 2 months after inclusion

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

Secondary outcomes

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

    Time frame: 12 and 24 months

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

  2. Changes in functional capacities with scales IADL

    Time frame: 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.

  3. Changes in functional capacities with scales ADL

    Time frame: 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.

  4. Changes in functional capacities with scales SPPB

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • MSDAVENIR

Registry information

Acronym: COGFRAIL

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Apr 26, 2017
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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