Mild Cognitive Impairment (MCI)AGINGNCT03138018
Aging Stereotypes and Prodromal Alzheimer's Disease
A study testing Diagnosis of MCI versus No MCI (SCI or healthy patient) in people with Mild Cognitive Impairment (MCI), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Diagnosis of MCI versus No MCI (SCI or healthy patient)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2018to 11 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Potential Impact of Aging Stereotypes in the Assessment of Memory Deficits and Screening for Prodromal State of Alzheimer's Disease
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)
- Being tested
- Diagnosis of MCI versus No MCI (SCI or healthy patient)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of MCI versus No MCI (SCI or healthy patient)Diagnostic test
Neuropsychological tests
Diagnosis of MCI versus No MCI (SCI or healthy patient)Diagnostic test
Neuroimaging biomarkers of neurodegeneration
| Study group | Role | What they receive |
|---|---|---|
| Standard instruction | Active comparator | Not described Receives: Diagnostic Test: Diagnosis of MCI versus No MCI (SCI or healthy patient) |
| Reduced threat instruction | Experimental | Not described Receives: Diagnostic Test: Diagnosis of MCI versus No MCI (SCI or healthy patient) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological tests
Neuropsychological battery used for the diagnosis of Mild Cognitive Impairment (MCI, amnestic single or multiple domain)
Measured: 48 months
Secondary outcomes (6)
Neuroimaging biomarkers of neurodegeneration
Structural MRI (Hippocamp) and Florbetapir© PET (β-amyloid deposition)
Measured: 48 months
Physiological stress
cortisol, dehydroepiandrosterone (DHEA) and its sulfated stable form (DHEAS) from the HPA axis, and Immunoglobulin A (IgA).
Measured: 48 months
Self-report questionnaires
Vulnerability factors for stereotyping threat effects are assessed
Measured: 48 months
Heart rate variability (thin elasticized heart rate transmitter belt),
Physiological stress
Measured: 48 months
Skin conductance (wristwatch)
Physiological stress
Measured: 48 months
Salivary biomarkers
cortisol, dehydroepiandrosterone (DHEA) and its sulfated stable form (DHEAS) from the HPA axis, and Immunoglobulin A (IgA).
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start6 Jul 2018
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Director, Study director, ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138018
- Sponsor's protocol ID
- 2016-45
- Other IDs
- IDRCB Number
- Acronym
- AGING
- Status last verified
- Oct 2026
- First submitted
- 10 Apr 2017
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morand, A., Gauthier, K., Mazerolle, M., Pélerin, A., Rigalleau, F., de La Sayette, V., Eustache, F., Desgranges, B., Huguet, P., & Régner, I. (2020). L'effet de menace du stéréotype en situation d'évaluation neuropsychologique: Enjeux cliniques [The stereotype threat effect during neuropsychological assessment: Clinical issues]. Revue de Neuropsychologie, Neurosciences Cognitives et Cliniques, 12(4), 358-366.
Gauthier, K., Morand, A., Mazerolle, M., Rigalleau, F., Eustache, F., Desgranges, B., Huguet, P., & Régner, I. (2020). Effet de menace du stéréotype: Historique, mécanismes, et conséquences sur les performances cognitives des personnes âgées [The stereotype threat effect: Historical context, mechanisms, and impact on cognitive performance in older adults]. Revue de Neuropsychologie, Neurosciences Cognitives et Cliniques, 12(4), 351-357.
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.
PubMed 31594904Le Tirant L, Likhanov M, Mazerolle M, Morand A, Eustache F, Huguet P; AGING Consortium; Regner I. Self-Perceptions of Aging in Older Adults: A Network Analysis of Clinical and Non-Clinical Samples. Brain Sci. 2026 Feb 9;16(2):204. doi: 10.3390/brainsci16020204.
PubMed 41750205Regner I, Huguet P. Age-based stereotype threat effects: From the laboratory to the clinical setting. Cortex. 2025 Feb;183:261-273. doi: 10.1016/j.cortex.2024.12.006. Epub 2024 Dec 25.
PubMed 39756332
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Impact of Aging Stereotypes in the Assessment of Memory Deficits and Screening for Prodromal State of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03138018
- Acronym / sponsor ID
- AGING / 2016-45
- Conditions
- Mild Cognitive Impairment (MCI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 6 Jul 2018 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard instruction | Active comparator | Diagnostic Test: Diagnosis of MCI versus No MCI (SCI or healthy patient) |
| Reduced threat instruction | Experimental | Diagnostic Test: Diagnosis of MCI versus No MCI (SCI or healthy patient) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis of MCI versus No MCI (SCI or healthy patient)Neuropsychological tests | Diagnostic test | Reduced threat instruction, Standard instruction |
| Diagnosis of MCI versus No MCI (SCI or healthy patient)Neuroimaging biomarkers of neurodegeneration | Diagnostic test | Reduced threat instruction, Standard instruction |
Primary outcome
Neuropsychological tests
Time frame: 48 months
Neuropsychological battery used for the diagnosis of Mild Cognitive Impairment (MCI, amnestic single or multiple domain)
6 secondary outcomes
Neuroimaging biomarkers of neurodegeneration
Time frame: 48 months
Physiological stress
Time frame: 48 months
Self-report questionnaires
Time frame: 48 months
Heart rate variability (thin elasticized heart rate transmitter belt),
Time frame: 48 months
Skin conductance (wristwatch)
Time frame: 48 months
Salivary biomarkers
Time frame: 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- BackgroundMorand, A., Gauthier, K., Mazerolle, M., Pélerin, A., Rigalleau, F., de La Sayette, V., Eustache, F., Desgranges, B., Huguet, P., & Régner, I. (2020). L'effet de menace du stéréotype en situation d'évaluation neuropsychologique: Enjeux cliniques [The stereotype threat effect during neuropsychological assessment: Clinical issues]. Revue de Neuropsychologie, Neurosciences Cognitives et Cliniques, 12(4), 358-366.
- BackgroundGauthier, K., Morand, A., Mazerolle, M., Rigalleau, F., Eustache, F., Desgranges, B., Huguet, P., & Régner, I. (2020). Effet de menace du stéréotype: Historique, mécanismes, et conséquences sur les performances cognitives des personnes âgées [The stereotype threat effect: Historical context, mechanisms, and impact on cognitive performance in older adults]. Revue de Neuropsychologie, Neurosciences Cognitives et Cliniques, 12(4), 351-357.
- Background: PubMed 31594904Gauthier 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.
- Results publication: PubMed 41750205Le Tirant L, Likhanov M, Mazerolle M, Morand A, Eustache F, Huguet P; AGING Consortium; Regner I. Self-Perceptions of Aging in Older Adults: A Network Analysis of Clinical and Non-Clinical Samples. Brain Sci. 2026 Feb 9;16(2):204. doi: 10.3390/brainsci16020204.
- Results publication: PubMed 39756332Regner I, Huguet P. Age-based stereotype threat effects: From the laboratory to the clinical setting. Cortex. 2025 Feb;183:261-273. doi: 10.1016/j.cortex.2024.12.006. Epub 2024 Dec 25.
- Individual participant dataSharing planned: No
Related trials for Mild Cognitive Impairment (MCI)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
Parkinson's Disease, Dementia
Recruiting
ENACT Program on Auditory Perception and Function, Cognitive Function and Health-related Quality of Life
Hearing Loss, Cognitive Impairment, Mild
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
Recruiting
Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Parkinson Disease, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urielle DESALBRES, Director study director
ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnosis of MCI versus No MCI (SCI or healthy patient) in people with Mild Cognitive Impairment (MCI), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological tests (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03138018, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.