Aging Stereotypes and Prodromal Alzheimer's Disease (AGING)
The Potential Impact of Aging Stereotypes in the Assessment of Memory Deficits and Screening for Prodromal State of Alzheimer's Disease
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Bernard MICHEL, PH
- Phone Number: +33 491744675
- Email: bmichel@ap-hm.fr
Study Contact Backup
- Name: Isabelle REGNER, PhD
- Phone Number: +33 413550993
- Email: isabelle.regner@univ-amu.fr
Study Locations
-
-
-
Marseille, France, 13354
- Recruiting
- Assistance Publique Hopitaux de Marseille
-
Contact:
- Bernard MICHEL, PH
- Phone Number: +33 491744675
- Email: bmichel@ap-hm.fr
-
Principal Investigator:
- Bernard MICHEL, PH
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Standard instruction
|
Neuropsychological tests
Neuroimaging biomarkers of neurodegeneration
|
|
Experimental: Reduced threat instruction
|
Neuropsychological tests
Neuroimaging biomarkers of neurodegeneration
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuropsychological tests
Time Frame: 48 months
|
Neuropsychological battery used for the diagnosis of Mild Cognitive Impairment (MCI, amnestic single or multiple domain)
|
48 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuroimaging biomarkers of neurodegeneration
Time Frame: 48 months
|
Structural MRI (Hippocamp) and Florbetapir© PET (β-amyloid deposition)
|
48 months
|
|
Physiological stress
Time Frame: 48 months
|
cortisol, dehydroepiandrosterone (DHEA) and its sulfated stable form (DHEAS) from the HPA axis, and Immunoglobulin A (IgA).
|
48 months
|
|
Self-report questionnaires
Time Frame: 48 months
|
Vulnerability factors for stereotyping threat effects are assessed
|
48 months
|
|
Heart rate variability (thin elasticized heart rate transmitter belt),
Time Frame: 48 months
|
Physiological stress
|
48 months
|
|
Skin conductance (wristwatch)
Time Frame: 48 months
|
Physiological stress
|
48 months
|
|
Salivary biomarkers
Time Frame: 48 months
|
cortisol, dehydroepiandrosterone (DHEA) and its sulfated stable form (DHEAS) from the HPA axis, and Immunoglobulin A (IgA).
|
48 months
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2016-45
- IDRCB number (Other Identifier: 2025-A02650-49)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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