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

Primary Purpose

Frail Elderly

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI and PET scan
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Frail Elderly focused on measuring Cognitive decline, frailty, mild cognitive impairment, Positron Emission Tomography, PET, Alzheimer disease, amyloid load, Magnetic resonance imaging, MRI

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Toulouse University Hospital (CHU de Toulouse)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

neuroimaging amyloid diagnosis by MRI and PET scan

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in cognitive function with Clinical Dementia Rating Scale (CDR)
Comparison between 2 timeframe to observe change in cognitive function between T12, T24 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.
Changes in functional capacities with scales ADL
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.
Changes in functional capacities with scales SPPB
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.

Full Information

First Posted
March 2, 2017
Last Updated
October 13, 2022
Sponsor
University Hospital, Toulouse
Collaborators
MSDAVENIR
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1. Study Identification

Unique Protocol Identification Number
NCT03129269
Brief Title
Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults
Acronym
COGFRAIL
Official Title
Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2, 2017 (Actual)
Primary Completion Date
January 2, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
MSDAVENIR

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly
Keywords
Cognitive decline, frailty, mild cognitive impairment, Positron Emission Tomography, PET, Alzheimer disease, amyloid load, Magnetic resonance imaging, MRI

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
345 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
neuroimaging amyloid diagnosis by MRI and PET scan
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
MRI and PET scan
Intervention Description
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 Outcome Measure Information:
Title
Amyloid physiological parameter
Description
Amyloid pathology as corroborated with amyloid Positron Emission Tomography (PET) or lumbar punction
Time Frame
2 months after inclusion
Secondary Outcome Measure Information:
Title
Change in cognitive function with Clinical Dementia Rating Scale (CDR)
Description
Comparison between 2 timeframe to observe change in cognitive function between T12, T24 months
Time Frame
12 and 24 months
Title
Changes in functional capacities with scales IADL
Description
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
Title
Changes in functional capacities with scales ADL
Description
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
Title
Changes in functional capacities with scales SPPB
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno VELLAS, MD, Ph D, Pr
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toulouse University Hospital (CHU de Toulouse)
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23831959
Citation
Robertson DA, Savva GM, Kenny RA. Frailty and cognitive impairment--a review of the evidence and causal mechanisms. Ageing Res Rev. 2013 Sep;12(4):840-51. doi: 10.1016/j.arr.2013.06.004. Epub 2013 Jul 4.
Results Reference
background
PubMed Identifier
25808052
Citation
Panza F, Solfrizzi V, Barulli MR, Santamato A, Seripa D, Pilotto A, Logroscino G. Cognitive Frailty: A Systematic Review of Epidemiological and Neurobiological Evidence of an Age-Related Clinical Condition. Rejuvenation Res. 2015 Oct;18(5):389-412. doi: 10.1089/rej.2014.1637. Epub 2015 Aug 20.
Results Reference
background
PubMed Identifier
27324809
Citation
Kojima G, Taniguchi Y, Iliffe S, Walters K. Frailty as a Predictor of Alzheimer Disease, Vascular Dementia, and All Dementia Among Community-Dwelling Older People: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2016 Oct 1;17(10):881-8. doi: 10.1016/j.jamda.2016.05.013. Epub 2016 Jun 17.
Results Reference
background
PubMed Identifier
18695161
Citation
Buchman AS, Schneider JA, Leurgans S, Bennett DA. Physical frailty in older persons is associated with Alzheimer disease pathology. Neurology. 2008 Aug 12;71(7):499-504. doi: 10.1212/01.wnl.0000324864.81179.6a.
Results Reference
background
PubMed Identifier
23635961
Citation
Buchman AS, Yu L, Wilson RS, Schneider JA, Bennett DA. Association of brain pathology with the progression of frailty in older adults. Neurology. 2013 May 28;80(22):2055-61. doi: 10.1212/WNL.0b013e318294b462. Epub 2013 May 1.
Results Reference
background
PubMed Identifier
24886728
Citation
Tavassoli N, Guyonnet S, Abellan Van Kan G, Sourdet S, Krams T, Soto ME, Subra J, Chicoulaa B, Ghisolfi A, Balardy L, Cestac P, Rolland Y, Andrieu S, Nourhashemi F, Oustric S, Cesari M, Vellas B; Geriatric Frailty Clinic (G.F.C) for Assessment of Frailty and Prevention of Disability Team. Description of 1,108 older patients referred by their physician to the "Geriatric Frailty Clinic (G.F.C) for Assessment of Frailty and Prevention of Disability" at the gerontopole. J Nutr Health Aging. 2014 May;18(5):457-64. doi: 10.1007/s12603-014-0462-z.
Results Reference
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Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults

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