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

April 28, 2026 updated by: University Hospital, Toulouse
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

344

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • Toulouse University Hospital (CHU de Toulouse)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amyloid physiological parameter
Time Frame: 2 months after inclusion
Amyloid pathology as corroborated with amyloid Positron Emission Tomography (PET) or lumbar punction
2 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 and 24 months
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.
12 and 24 months
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.
12 and 24 months
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.
12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

MSDAVENIR

Investigators

  • Principal Investigator: Bruno VELLAS, MD, Ph D, Pr, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2017

Primary Completion (Actual)

June 16, 2024

Study Completion (Actual)

June 16, 2024

Study Registration Dates

First Submitted

March 2, 2017

First Submitted That Met QC Criteria

April 21, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/16/8753

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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