Ageing stereotypes and prodromal Alzheimer's disease (AGING): study protocol for an ongoing randomised clinical study.
Alzheimer disease
aging stereotypes
amyloid PET
diagnosis
mild cognitive impairment
stereotype threat
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
07 10 2019
07 10 2019
Historique:
entrez:
10
10
2019
pubmed:
9
10
2019
medline:
21
10
2020
Statut:
epublish
Résumé
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. 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. 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. NCT03138018.
Identifiants
pubmed: 31594904
pii: bmjopen-2019-032265
doi: 10.1136/bmjopen-2019-032265
pmc: PMC6797355
doi:
Banques de données
ClinicalTrials.gov
['NCT03138018']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e032265Investigateurs
José Broucraut
(J)
Boris Dufournet
(B)
Carine Giallo
(C)
Nadine Girard
(N)
Eric Guedj
(E)
Bernard François Michel
(BF)
Nathalie Sambuchi
(N)
Pierre Branger
(P)
Julien Cogez
(J)
Sabine Fradin
(S)
Frédérique Grandhomme
(F)
Catherine Lalevée
(C)
Nadège Loisel
(N)
Olivier Martinaud
(O)
Alice Pélerin
(A)
Mélissa Pierre
(M)
Vincent de La Sayette
(V)
Alain Manrique
(A)
Vanessa Baudifier
(V)
Foucaud du Boisgueheneuc
(FD)
Adrien Julian
(A)
Jean-Claude Lecron
(JC)
Isabelle Merlet
(I)
Claudie Ornon
(C)
Marc Paccalin
(M)
Sandrine Bioux
(S)
Evangeline Bliaux
(E)
Didier Hannequin
(D)
Véronique Hannier
(V)
Maud Loubeyre
(M)
Dorothée Pouliquen
(D)
Muriel Quillard-Muraine
(M)
David Wallon
(D)
Aline Zaréa
(A)
Kim Gauthier
(K)
Béatrice Alescio-Lautier
(B)
Véronique Paban
(V)
Arnaud Weill
(A)
David Clarys
(D)
Michel Isingrini
(M)
Sandrine Kalenzaga
(S)
François Rigalleau
(F)
Ahmed Abbas
(A)
Julien Chavant
(J)
Béatrice Desgranges
(B)
Francis Eustache
(F)
Florence Fraisse
(F)
Mickael Laisney
(M)
Alexandrine Morand
(A)
Shailendra Segobin
(S)
Pierre Chausse
(P)
Frédéric Dutheil
(F)
Julien Guegan
(J)
Pascal Huguet
(P)
Guillaume Vallet
(G)
Sophie Blanchet
(S)
Pascale Piolino
(P)
Marie Mazerolle
(M)
Isabelle Régner
(I)
Informations de copyright
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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