Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults

NCT03129269 | Completed

• 1 other identifier: RC31/16/8753
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail Elderly

Keywords

Cognitive decline; frailty; mild cognitive impairment; Positron Emission Tomography, PET; Alzheimer disease; amyloid load; Magnetic resonance imaging, MRI

Outcome Measures

Primary Outcomes (1)

• Amyloid physiological parameter

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

  2 months after inclusion

Secondary Outcomes (4)

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

  12 and 24 months

• Changes in functional capacities with scales IADL

  12 and 24 months

• Changes in functional capacities with scales ADL

  12 and 24 months

• Changes in functional capacities with scales SPPB

  12 and 24 months

Study Arms (1)

neuroimaging amyloid diagnosis by MRI and PET scan

EXPERIMENTAL

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

Interventions

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.

neuroimaging amyloid diagnosis by MRI and PET scan

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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);
• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• MSDAVENIR: collaborator

Study Sites (1)

Toulouse University Hospital (CHU de Toulouse)

Toulouse, 31059, France

Location

Related Publications (10)

• 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.

  PMID: 23831959 BACKGROUND

• 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.

  PMID: 25808052 BACKGROUND

• 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.

  PMID: 27324809 BACKGROUND

• 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.

  PMID: 18695161 BACKGROUND

• 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.

  PMID: 23635961 BACKGROUND

• 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.

  PMID: 24886728 BACKGROUND

• Grande de Franca NA, Diaz G, Lengele L, Soriano G, Caspar-Bauguil S, Saint-Aubert L, Payoux P, Rouch L, Vellas B, de Souto Barreto P, Sourdet S. Associations Between Blood Nutritional Biomarkers and Cerebral Amyloid-beta: Insights From the COGFRAIL Cohort Study. J Gerontol A Biol Sci Med Sci. 2024 Jan 1;79(1):glad248. doi: 10.1093/gerona/glad248.

  PMID: 37879623 RESULT

• Sourdet S, Soriano G, Delrieu J, Steinmeyer Z, Guyonnet S, Saint-Aubert L, Payoux P, Ousset PJ, Ghisolfi A, Chicoulaa B, Dardenne S, Gemar T, Baziard M, Guerville F, Andrieu S, Vellas B. Cognitive Function and Amyloid Marker in Frail Older Adults: The COGFRAIL Cohort Study. J Frailty Aging. 2021;10(2):160-167. doi: 10.14283/jfa.2020.57.

  PMID: 33575706 RESULT

• Lengele L, Sourdet S, Soriano G, Rolland Y, Soler V, de Souto Barreto P. Cross-sectional associations of dietary intake with hearing and vision capacities and potential mediation effect of inflammation in older adults: the COGFRAIL study. Aging Clin Exp Res. 2023 Jun;35(6):1325-1337. doi: 10.1007/s40520-023-02418-7. Epub 2023 Apr 29.

  PMID: 37119508 RESULT

• Bellelli F, Delrieu J, van Kan GA, Peluso A, Soriano G, Vellas B, Angioni D, Sourdet S. Are pre-frail and frail amyloid positive individuals eligible to Lecanemab? A cross-sectional analysis from the Cogfrail real-world cohort. Alzheimers Res Ther. 2026 Feb 4;18(1):56. doi: 10.1186/s13195-026-01966-0.

  PMID: 41634843 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Frailty; Alzheimer Disease

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Bruno VELLAS, MD, Ph D, Pr

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: April 26, 2017
• Study Start: January 2, 2017
• Primary Completion: June 16, 2024
• Study Completion: June 16, 2024
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)