Aging Stereotypes and Prodromal Alzheimer's Disease (AGING)
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ClinicalTrials.gov Identifier: NCT03138018 |
Recruitment Status :
Recruiting
First Posted : May 3, 2017
Last Update Posted : July 26, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mild Cognitive Impairment (MCI) | Diagnostic Test: Diagnosis of MCI versus No MCI (SCI or healthy patient) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 260 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Diagnostic |
Official Title: | The Potential Impact of Aging Stereotypes in the Assessment of Memory Deficits and Screening for Prodromal State of Alzheimer's Disease |
Actual Study Start Date : | July 6, 2018 |
Estimated Primary Completion Date : | July 1, 2023 |
Estimated Study Completion Date : | July 1, 2023 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Standard instruction |
Diagnostic Test: Diagnosis of MCI versus No MCI (SCI or healthy patient)
Neuropsychological tests Diagnostic Test: Diagnosis of MCI versus No MCI (SCI or healthy patient) Neuroimaging biomarkers of neurodegeneration |
Experimental: Reduced threat instruction |
Diagnostic Test: Diagnosis of MCI versus No MCI (SCI or healthy patient)
Neuropsychological tests Diagnostic Test: Diagnosis of MCI versus No MCI (SCI or healthy patient) Neuroimaging biomarkers of neurodegeneration |
- Neuropsychological tests [ Time Frame: 48 months ]Neuropsychological battery used for the diagnosis of Mild Cognitive Impairment (MCI, amnestic single or multiple domain)
- Neuroimaging biomarkers of neurodegeneration [ Time Frame: 48 months ]Structural MRI (Hippocamp) and Florbetapir© PET (β-amyloid deposition)
- Physiological stress [ Time Frame: 48 months ]cortisol, dehydroepiandrosterone (DHEA) and its sulfated stable form (DHEAS) from the HPA axis, and Immunoglobulin A (IgA).
- Self-report questionnaires [ Time Frame: 48 months ]Vulnerability factors for stereotyping threat effects are assessed
- Heart rate variability (thin elasticized heart rate transmitter belt), [ Time Frame: 48 months ]Physiological stress
- Skin conductance (wristwatch) [ Time Frame: 48 months ]Physiological stress
- Salivary biomarkers [ Time Frame: 48 months ]cortisol, dehydroepiandrosterone (DHEA) and its sulfated stable form (DHEAS) from the HPA axis, and Immunoglobulin A (IgA).

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138018
Contact: Bernard MICHEL, PH | 491744675 ext +33 | bmichel@ap-hm.fr | |
Contact: Isabelle REGNER, PhD | 413550993 ext +33 | isabelle.regner@univ-amu.fr |
France | |
Assistance Publique Hôpitaux de Marseille | Recruiting |
Marseille, France, 13354 | |
Contact: Bernard MICHEL, PH 491744675 ext +33 bmichel@ap-hm.fr | |
Principal Investigator: Bernard MICHEL, PH |
Study Director: | Urielle DESALBRES, Director | ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE |
Responsible Party: | Assistance Publique Hopitaux De Marseille |
ClinicalTrials.gov Identifier: | NCT03138018 |
Other Study ID Numbers: |
2016-45 IDRCB Number ( Other Identifier: 2017-A00946-47 ) |
First Posted: | May 3, 2017 Key Record Dates |
Last Update Posted: | July 26, 2018 |
Last Verified: | July 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Alzheimer Disease Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders |