Ageing stereotypes and prodromal Alzheimer’s disease (AGING): study protocol for an ongoing randomised clinical study
Introduction The number of older people diagnosed with amnestic mild cognitive impairment (aMCI), the prodromal state of Alzheimer's disease (AD), is increasing worldwide. However, some patients with aMCI never convert to the AD type of dementia, with some remaining stable and others reverting...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2019-10-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/10/e032265.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850104606659444736 |
|---|---|
| author | Ahmed Abbas Didier Hannequin Olivier Martinaud David Wallon Vincent de la Sayette Adrien Julian Marc Paccalin Julien Cogez Kim Gauthier Alexandrine Morand Frederic Dutheil Béatrice Alescio-Lautier José Boucraut David Clarys Francis Eustache Nadine Girard Eric Guedj Marie Mazerolle Aline Zaréa Pascal Huguet Bernard F Michel Béatrice Desgranges Isabelle Régner José Broucraut Boris Dufournet Carine Giallo Bernard François Michel Nathalie Sambuchi Pierre Branger Sabine Fradin Frédérique Grandhomme Catherine Lalevée Nadège Loisel Alice Pélerin Mélissa Pierre Vincent de La Sayette Alain Manrique Vanessa Baudifier Foucaud du Boisgueheneuc Jean-Claude Lecron Isabelle Merlet Claudie Ornon Sandrine Bioux Evangeline Bliaux Véronique Hannier Maud Loubeyre Dorothée Pouliquen Muriel Quillard-Muraine Véronique Paban Arnaud Weill Michel Isingrini Sandrine Kalenzaga François Rigalleau Julien Chavant Florence Fraisse Mickael Laisney Shailendra Segobin Pierre Chausse Julien Guegan Guillaume Vallet Sophie Blanchet Pascale Piolino |
| author_facet | Ahmed Abbas Didier Hannequin Olivier Martinaud David Wallon Vincent de la Sayette Adrien Julian Marc Paccalin Julien Cogez Kim Gauthier Alexandrine Morand Frederic Dutheil Béatrice Alescio-Lautier José Boucraut David Clarys Francis Eustache Nadine Girard Eric Guedj Marie Mazerolle Aline Zaréa Pascal Huguet Bernard F Michel Béatrice Desgranges Isabelle Régner José Broucraut Boris Dufournet Carine Giallo Bernard François Michel Nathalie Sambuchi Pierre Branger Sabine Fradin Frédérique Grandhomme Catherine Lalevée Nadège Loisel Alice Pélerin Mélissa Pierre Vincent de La Sayette Alain Manrique Vanessa Baudifier Foucaud du Boisgueheneuc Jean-Claude Lecron Isabelle Merlet Claudie Ornon Sandrine Bioux Evangeline Bliaux Véronique Hannier Maud Loubeyre Dorothée Pouliquen Muriel Quillard-Muraine Véronique Paban Arnaud Weill Michel Isingrini Sandrine Kalenzaga François Rigalleau Julien Chavant Florence Fraisse Mickael Laisney Shailendra Segobin Pierre Chausse Julien Guegan Guillaume Vallet Sophie Blanchet Pascale Piolino |
| author_sort | Ahmed Abbas |
| collection | DOAJ |
| description | Introduction The number of older people diagnosed with amnestic mild cognitive impairment (aMCI), the prodromal state of Alzheimer's disease (AD), is increasing worldwide. However, some patients with aMCI never convert to the AD type of dementia, with some remaining stable and others reverting to normal. This overdiagnosis bias has been largely overlooked and gone unexplained. There is ample evidence in the laboratory that negative ageing stereotypes (eg, the culturally shared belief that ageing inescapably causes severe cognitive decline) contribute to the deteriorating cognitive performances of healthy older adults, leading them to perform below their true abilities. The study described here is intended to test for the first time whether such stereotypes also impair patients’ cognitive performances during neuropsychological examinations in memory clinics, resulting in overdiagnosis of aMCI.Methods and analysis The ongoing study is a 4-year randomised clinical trial comparing patients’ physiological stress and cognitive performances during neuropsychological testing in memory clinics. A total of 260 patients attending their first cognitive evaluation will be randomised to either a standard condition of test administration, assumed here to implicitly activate negative ageing stereotypes or a reduced-threat instruction condition designed to alleviate the anxiety arising from these stereotypes. Both groups will be tested with the same test battery and stress biomarkers. For 30 patients diagnosed with aMCI in each group (n=60), biomarkers of neurodegeneration and amyloidopathy will be used to distinguish between aMCI with normal versus abnormal AD biomarkers. A 9-month follow-up will be performed on all patients to identify those whose cognitive performances remain stable, deteriorate or improve.Ethics and dissemination This protocol has been approved by the French National Agency for Medicines and Health Products Safety and the Sud-Est I French Ethics Committee (2017-A00946-47). Results will be published in peer-reviewed journals.Trial registration number NCT03138018. |
| format | Article |
| id | doaj-art-2c50985b758643528f640cb2fbd089df |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-2c50985b758643528f640cb2fbd089df2025-08-20T02:39:18ZengBMJ Publishing GroupBMJ Open2044-60552019-10-0191010.1136/bmjopen-2019-032265Ageing stereotypes and prodromal Alzheimer’s disease (AGING): study protocol for an ongoing randomised clinical studyAhmed Abbas0Didier Hannequin1Olivier MartinaudDavid WallonVincent de la Sayette2Adrien JulianMarc Paccalin3Julien CogezKim Gauthier4Alexandrine Morand5Frederic Dutheil6Béatrice Alescio-Lautier7José Boucraut8David Clarys9Francis Eustache10Nadine Girard11Eric Guedj12Marie Mazerolle13Aline Zaréa14Pascal Huguet15Bernard F Michel16Béatrice Desgranges17Isabelle Régner18José BroucrautBoris DufournetCarine GialloBernard François MichelNathalie SambuchiPierre BrangerSabine FradinFrédérique GrandhommeCatherine LalevéeNadège LoiselAlice PélerinMélissa PierreVincent de La SayetteAlain ManriqueVanessa BaudifierFoucaud du BoisgueheneucJean-Claude LecronIsabelle MerletClaudie OrnonSandrine BiouxEvangeline BliauxVéronique HannierMaud LoubeyreDorothée PouliquenMuriel Quillard-MuraineVéronique PabanArnaud WeillMichel IsingriniSandrine KalenzagaFrançois RigalleauJulien ChavantFlorence FraisseMickael LaisneyShailendra SegobinPierre ChausseJulien GueganGuillaume ValletSophie BlanchetPascale Piolino1Anaesthesia, Rotunda Hospital, Dublin, Ireland11 Centre National de Référence pour les Malades Alzheimer Jeunes, Centre Hospitalier Universitaire de Rouen, INSERM 1245, Rouen, France2 Normandie Université, UNICAEN, PSL Universités Paris, EPHE, INSERM, U1077, CHU de Caen, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, France2University Hospital, Department of Geriatric Medicine, Poitiers, France1 Aix Marseille Univ, CNRS, LPC, Marseille, France2 Normandie Université, UNICAEN, PSL Universités Paris, EPHE, INSERM, U1077, CHU de Caen, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, France4 Physiological and Psychosocial Stress, University Hospital of Clermont-Ferrand, CHU Clermont-Ferrand, Preventive and Occupational Medicine, WittyFit, Clermont-Ferrand, France5 Aix Marseille Univ, CNRS, LNSC, Marseille, France6 Immunology Laboratory, Assistance Publique–Hôpitaux de Marseille, Conception Hospital, Marseille, FranceCentre de Recherches sur la Cognition et l`Apprentissage, Université de Tours, Université de Poitiers, CNRS, Tours, Poitiers, France2 Normandie Université, UNICAEN, PSL Universités Paris, EPHE, INSERM, U1077, CHU de Caen, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, France9 Aix Marseille Univ, CRMBM UMR CNRS 7339, APHM Timone Neuroradiologie, Marseille, France5 Department of Nuclear Medicine, La Timone Hospital, Marseille, France11 Department and Laboratory of Psychology, MSHE, Université Bourgogne Franche-Comté, Besançon, France13 Department of Neurology, Rouen University Hospital and University of Rouen, Rouen, France3 Université Clermont Auvergne, CNRS, LAPSCO, Clermont-Ferrand, France14 Departement of Neurological Behavior, Assistance Publique-Hôpitaux de Marseille, Sainte-Marguerite University Hospital, Marseille, France2 Normandie Université, UNICAEN, PSL Universités Paris, EPHE, INSERM, U1077, CHU de Caen, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, France1 Aix Marseille Univ, CNRS, LPC, Marseille, FranceIntroduction The number of older people diagnosed with amnestic mild cognitive impairment (aMCI), the prodromal state of Alzheimer's disease (AD), is increasing worldwide. However, some patients with aMCI never convert to the AD type of dementia, with some remaining stable and others reverting to normal. This overdiagnosis bias has been largely overlooked and gone unexplained. There is ample evidence in the laboratory that negative ageing stereotypes (eg, the culturally shared belief that ageing inescapably causes severe cognitive decline) contribute to the deteriorating cognitive performances of healthy older adults, leading them to perform below their true abilities. The study described here is intended to test for the first time whether such stereotypes also impair patients’ cognitive performances during neuropsychological examinations in memory clinics, resulting in overdiagnosis of aMCI.Methods and analysis The ongoing study is a 4-year randomised clinical trial comparing patients’ physiological stress and cognitive performances during neuropsychological testing in memory clinics. A total of 260 patients attending their first cognitive evaluation will be randomised to either a standard condition of test administration, assumed here to implicitly activate negative ageing stereotypes or a reduced-threat instruction condition designed to alleviate the anxiety arising from these stereotypes. Both groups will be tested with the same test battery and stress biomarkers. For 30 patients diagnosed with aMCI in each group (n=60), biomarkers of neurodegeneration and amyloidopathy will be used to distinguish between aMCI with normal versus abnormal AD biomarkers. A 9-month follow-up will be performed on all patients to identify those whose cognitive performances remain stable, deteriorate or improve.Ethics and dissemination This protocol has been approved by the French National Agency for Medicines and Health Products Safety and the Sud-Est I French Ethics Committee (2017-A00946-47). Results will be published in peer-reviewed journals.Trial registration number NCT03138018.https://bmjopen.bmj.com/content/9/10/e032265.full |
| spellingShingle | Ahmed Abbas Didier Hannequin Olivier Martinaud David Wallon Vincent de la Sayette Adrien Julian Marc Paccalin Julien Cogez Kim Gauthier Alexandrine Morand Frederic Dutheil Béatrice Alescio-Lautier José Boucraut David Clarys Francis Eustache Nadine Girard Eric Guedj Marie Mazerolle Aline Zaréa Pascal Huguet Bernard F Michel Béatrice Desgranges Isabelle Régner José Broucraut Boris Dufournet Carine Giallo Bernard François Michel Nathalie Sambuchi Pierre Branger Sabine Fradin Frédérique Grandhomme Catherine Lalevée Nadège Loisel Alice Pélerin Mélissa Pierre Vincent de La Sayette Alain Manrique Vanessa Baudifier Foucaud du Boisgueheneuc Jean-Claude Lecron Isabelle Merlet Claudie Ornon Sandrine Bioux Evangeline Bliaux Véronique Hannier Maud Loubeyre Dorothée Pouliquen Muriel Quillard-Muraine Véronique Paban Arnaud Weill Michel Isingrini Sandrine Kalenzaga François Rigalleau Julien Chavant Florence Fraisse Mickael Laisney Shailendra Segobin Pierre Chausse Julien Guegan Guillaume Vallet Sophie Blanchet Pascale Piolino Ageing stereotypes and prodromal Alzheimer’s disease (AGING): study protocol for an ongoing randomised clinical study BMJ Open |
| title | Ageing stereotypes and prodromal Alzheimer’s disease (AGING): study protocol for an ongoing randomised clinical study |
| title_full | Ageing stereotypes and prodromal Alzheimer’s disease (AGING): study protocol for an ongoing randomised clinical study |
| title_fullStr | Ageing stereotypes and prodromal Alzheimer’s disease (AGING): study protocol for an ongoing randomised clinical study |
| title_full_unstemmed | Ageing stereotypes and prodromal Alzheimer’s disease (AGING): study protocol for an ongoing randomised clinical study |
| title_short | Ageing stereotypes and prodromal Alzheimer’s disease (AGING): study protocol for an ongoing randomised clinical study |
| title_sort | ageing stereotypes and prodromal alzheimer s disease aging study protocol for an ongoing randomised clinical study |
| url | https://bmjopen.bmj.com/content/9/10/e032265.full |
| work_keys_str_mv | AT ahmedabbas ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT didierhannequin ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT oliviermartinaud ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT davidwallon ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT vincentdelasayette ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT adrienjulian ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT marcpaccalin ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT juliencogez ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT kimgauthier ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT alexandrinemorand ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT fredericdutheil ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT beatricealesciolautier ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT joseboucraut ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT davidclarys ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT franciseustache ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT nadinegirard ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT ericguedj ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT mariemazerolle ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT alinezarea ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT pascalhuguet ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT bernardfmichel ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT beatricedesgranges ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT isabelleregner ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT josebroucraut ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT borisdufournet ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT carinegiallo ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT bernardfrancoismichel ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT nathaliesambuchi ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT pierrebranger ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT sabinefradin ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT frederiquegrandhomme ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT catherinelalevee ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT nadegeloisel ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT alicepelerin ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT melissapierre ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT vincentdelasayette ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT alainmanrique ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT vanessabaudifier ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT foucaudduboisgueheneuc ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT jeanclaudelecron ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT isabellemerlet ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT claudieornon ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT sandrinebioux ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT evangelinebliaux ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT veroniquehannier ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT maudloubeyre ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT dorotheepouliquen ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT murielquillardmuraine ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT veroniquepaban ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT arnaudweill ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT michelisingrini ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT sandrinekalenzaga ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT francoisrigalleau ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT julienchavant ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT florencefraisse ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT mickaellaisney ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT shailendrasegobin ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT pierrechausse ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT julienguegan ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT guillaumevallet ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT sophieblanchet ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy AT pascalepiolino ageingstereotypesandprodromalalzheimersdiseaseagingstudyprotocolforanongoingrandomisedclinicalstudy |