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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03129269
Recruitment Status : Active, not recruiting
First Posted : April 26, 2017
Last Update Posted : October 17, 2022
Sponsor:
Collaborator:
MSDAVENIR
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2, 2017
Estimated Primary Completion Date : January 2, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Amyloid physiological parameter [ Time Frame: 2 months after inclusion ]
    Amyloid pathology as corroborated with amyloid Positron Emission Tomography (PET) or lumbar punction


Secondary Outcome Measures :
  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.



Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129269


Locations
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France
Toulouse University Hospital (CHU de Toulouse)
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
MSDAVENIR
Investigators
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Principal Investigator: Bruno VELLAS, MD, Ph D, Pr University Hospital, Toulouse
More Information
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Publications:

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03129269    
Other Study ID Numbers: RC31/16/8753
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: October 17, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Cognitive decline
frailty
mild cognitive impairment
Positron Emission Tomography, PET
 Alzheimer disease
amyloid load
Magnetic resonance imaging, MRI
Additional relevant MeSH terms:
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Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases