Aging Stereotypes and Prodromal Alzheimer's Disease

NCT ID: NCT03138018

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-06
• Study Completion Date: 2023-07-01

Brief Summary

Because of the lengthening of life expectancy, more and more people are concerned with the effects of aging on their mental faculties (e.g., memory decline) and with the possibility of getting Alzheimer's Disease (AD) or other forms of dementia. This increasing awareness of AD has already resulted in a growing demand for neuropsychological testing. AD's research also emphasizes the need for early screening to improve the prediction of the disease progression and the efficacy of any future therapy. Such a drive to screen for pre-dementia raises the challenging issue of frontline identification of individuals in the preclinical or early clinical stages of AD. Mild Cognitive Impairment (MCI) is typically considered to be the prodromal state of AD, and is therefore at the core of the drive for early screening. Moreover, Pre-MCI so called SCI (Subjective Cognitive Impairment) can precede AD for 15 years. However, many individuals diagnosed with MCI do not convert to AD, some remaining stable and others even reversing back to normal (with rates of reversion to normal varying from 4.5% to as high as 53%). This over-diagnosis bias, which has been largely overlooked, is at the core of the present project at the interface of human and life sciences. Here, we argue that an important source of overdiagnosis in the prodromal state of AD comes from negative aging stereotypes (e.g., the culturally shared beliefs that aging inescapably causes severe cognitive decline and diseases such as AD) that permeate neuropsychological screening. There is ample evidence in the laboratory that such stereotypes contribute to the differences observed in the healthy population between younger and older adults in explicit memory tasks. Additionally, three pilot (lab) studies specifically conducted for the present ANR project showed that the threat of being judged stereotypically undermines the controlled use of memory of healthy older adults and simultaneously intensifies their automatic response tendencies, resulting in impaired memory performance. The present proposal goes several steps further by examining for the first time whether aging stereotypes are powerful enough to implicitly permeate the clinical neuropsychological testing and thus inflate memory deficits in older adults judged "at risk" (based on either epidemiological criteria or memory complaints), resulting in false-positive detection of SCI and MCI. This provocative hypothesis will be tested while 1) using biomarkers of neurodegeneration to distinguish false-positives from true MCI, and 2) using biomarkers of stress to examine whether and how aging stereotypes can lead to acute physiological stress during neuropsychological testing. This innovative project has the potential to offer new recommendations to improve the diagnosis accuracy of prodromal state of AD, with positive consequences for older people's wellbeing.

Conditions

Mild Cognitive Impairment (MCI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Standard instruction

Group Type: ACTIVE_COMPARATOR

Diagnosis of MCI versus No MCI (SCI or healthy patient)

Intervention Type: DIAGNOSTIC_TEST

Neuropsychological tests

Diagnosis of MCI versus No MCI (SCI or healthy patient)

Intervention Type: DIAGNOSTIC_TEST

Neuroimaging biomarkers of neurodegeneration

Reduced threat instruction

Group Type: EXPERIMENTAL

Diagnosis of MCI versus No MCI (SCI or healthy patient)

Intervention Type: DIAGNOSTIC_TEST

Neuropsychological tests

Diagnosis of MCI versus No MCI (SCI or healthy patient)

Intervention Type: DIAGNOSTIC_TEST

Neuroimaging biomarkers of neurodegeneration

Interventions

Diagnosis of MCI versus No MCI (SCI or healthy patient)

Neuropsychological tests

Intervention Type: DIAGNOSTIC_TEST

Diagnosis of MCI versus No MCI (SCI or healthy patient)

Neuroimaging biomarkers of neurodegeneration

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients must be at least 50 years old
• Patients must report memory complaints
• Patients must show signs of MCI (amnestic single or multiple domain) on the following short cognitive tests

Exclusion Criteria

• Probable Alzheimer's Disease according to NINCDS-ADRDA criteria (MA patients will be excluded from the study because false-positive errors only concern MCI status, not AD)
• Psychiatric disorders (schizophrenia, bipolar disorder)
• Cranial trauma
• Developmental pathologies
• Depression (score greater than or equal to 10 on GDS)
• Psychotropic medication if modified in the last 3 months

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urielle DESALBRES, Director

Role: STUDY_DIRECTOR

ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Bernard MICHEL, PH

Role: CONTACT

bmichel@ap-hm.fr

491744675 ext. +33

Isabelle REGNER, PhD

Role: CONTACT

isabelle.regner@univ-amu.fr

413550993 ext. +33

Facility Contacts

Bernard MICHEL, PH

Role: primary

bmichel@ap-hm.fr

491744675 ext. +33

References

Gauthier K, Morand A, Dutheil F, Alescio-Lautier B, Boucraut J, Clarys D, Eustache F, Girard N, Guedj E, Mazerolle M, Paccalin M, de la Sayette V, Zarea A, Huguet P, Michel BF, Desgranges B; AGING consortium; Regner I. Ageing stereotypes and prodromal Alzheimer's disease (AGING): study protocol for an ongoing randomised clinical study. BMJ Open. 2019 Oct 7;9(10):e032265. doi: 10.1136/bmjopen-2019-032265.

Reference Type: DERIVED

PMID: 31594904 (View on PubMed)

Other Identifiers

IDRCB Number

Identifier Type: OTHER

Identifier Source: secondary_id

2016-45

Identifier Type: -

Identifier Source: org_study_id