Lack of Decision-making in Patients With Alzheimer's Disease : Functions Involved and the Daily Consequences (MAPdP)
Primary Purpose
Alzheimer Disease
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cognitive assessment
Inhibition evaluation
Assessment of mental flexibility
Evaluation of the update
working memory
episodic memory
Sponsored by
About this trial
This is an interventional other trial for Alzheimer Disease focused on measuring decision making, Iowa Gambling Task
Eligibility Criteria
Inclusion Criteria for patients with Alzheimer's disease :
- Mini-Mental State Examination > 23
- stable treatment for at least two months
- mother tongue : French
Inclusion Criteria for control :
- general cognitive level in the standard on the following tests : Mini-Mental State Examination and Fast Front End Efficiency Battery
- mother tongue : French
Exclusion Criteria for patients with Alzheimer's disease :
- game addiction
- uncorrected visual and hearing disorders
- other neurological or psychiatric history
- inability to communicate
- delusional or psychotic state
Exclusion Criteria for control :
- game addiction
- psychiatric or neurological disorders
- anxiety and depression symptomatology
Sites / Locations
- Laboratoire d'Etude des Mécanismes CognitifsRecruiting
- Hôpital Lariboisière- Fernand Widal
- CHU de Saint EtienneRecruiting
- CMRR - Hôpital Charpennes
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Other
Other
Other
Other
Other
Other
Arm Label
Alzheimer's patients (lack of executive functions)
control (lack of executive functions)
Alzheimer's patients (lack of working memory)
control (lack of working memory)
Alzheimer's patients (lack of episodic memory)
control (lack of episodic memory)
Arm Description
Outcomes
Primary Outcome Measures
Score obtained (the number of correct answers) by participants in tasks evaluating decision-making
measured with two decision-making tasks : Iowa Gambling Task and one experimental task
Secondary Outcome Measures
Score obtained in task evaluating executive functions
measured with Stroop Victoria
Score obtained in task evaluating executive functions
measured with Stop Signal on computer
Score obtained in task evaluating executive functions
measured with a letter-number pair task
Score obtained in task evaluating executive functions
measured with a category change task.
Score obtained in task evaluating executive functions
measured with an update span task and a n-back task.
Score obtained in task evaluating working memory
measured with the task of empan baba.
Score obtained in task evaluating working memory
measured with the task of reading operations.
Score obtained in task evaluating working memory
measured with the continuous operation task.
Scores obtained in tasks evaluating episodic memory
measured with a recognition task with a Remember/Know paradigm
Scores obtained from the quality of life questionnaire.
measured with Quality of Life in Alzheimer's Disease : it is composed of 13 items (ex: physical health, memory, relationship with friends...). the patient must rate according to 4 possibilities: bad, fairly good, good or excellent. There is one copy to be completed by the patient and another by the caregiver.
Scores obtained from autonomy questionnaire.
measured with Direct Assessment of Functional Status : assessment of several areas of daily life (spatial and temporal orientation, communication skills, driving, financial management, shopping ability, behaviour food and hygiene). It consists of 7 subscales, allowing each competency to be assessed independently.
Full Information
NCT ID
NCT03991624
First Posted
February 25, 2019
Last Updated
April 20, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT03991624
Brief Title
Lack of Decision-making in Patients With Alzheimer's Disease : Functions Involved and the Daily Consequences
Acronym
MAPdP
Official Title
Lack of Decision-making in Patients With Alzheimer's Disease : Functions Involved and the Daily Consequences
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Early in its development, Alzheimer's disease causes not only brain damage affecting different regions of the brain, such as the entorhinal cortex, the anterior cingulate cortex, and the prefrontal lobe, but also a cognitive deficit affecting several functions, such as episodic memory, executive functions, or working memory. Although these different areas and functions are involved in the decision-making process, few studies have focused their research on this subject in the context of Alzheimer's disease. However, a 2008 study showed an early decline in decision-making skills in the disease, but did not link this deficit to cognitive impairment. In addition, decision-making is generally assessed using a test called the Iowa Gambling Task (IGT), which, despite its many advantages, does not have established ecological validity.
In the context of pathology, however, it seems essential to evaluate decision-making in relation to daily life, especially since a deficit in this process would have considerable repercussions on quality of life.
In this study, the investigators seek to better define the disorder by decision-making in early Alzheimer's disease, to understand the links between them with the deficit of other cognitive functions, and to highlight the the consequences that this decline has on patients' daily lives.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
decision making, Iowa Gambling Task
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alzheimer's patients (lack of executive functions)
Arm Type
Other
Arm Title
control (lack of executive functions)
Arm Type
Other
Arm Title
Alzheimer's patients (lack of working memory)
Arm Type
Other
Arm Title
control (lack of working memory)
Arm Type
Other
Arm Title
Alzheimer's patients (lack of episodic memory)
Arm Type
Other
Arm Title
control (lack of episodic memory)
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
cognitive assessment
Intervention Description
MMSE : Mini-Mental State Examination
5 words of Dubois
Direct Assessment of Functional Status
Trail Making Test
BREF : Fast Front End Efficiency Battery
short battery of praxies
Quality of Life in Alzheimer's Disease
Intervention Type
Other
Intervention Name(s)
Inhibition evaluation
Intervention Description
Stroop Victoria : This test consists of 3 sheets of 24 items, organized in 6 lines of 4 (points, neutral words or names of colours), from which the subject must identify the ink of the stimuli as quickly and precisely as possible.
Stop Signal task on the computer to give a response to the presentation of a target stimulus (Go signal) (e.g. pressing a button when a red circle appears on the screen, but doing nothing when a blue triangle appears), and prevent this response when the stimulus is followed or preceded by a beep (stop signal) (e.g. the appearance of a red circle is immediately preceded or followed by a beep, the subject should not press the button).
Intervention Type
Other
Intervention Name(s)
Assessment of mental flexibility
Intervention Description
a letter-number pair task. The subject sees 4 blocks of 48 letter-number pairs appear successively on a screen. When the pair appears at the top, the subject must make a parity judgment but when the pair appears at the bottom, the subject must make a consonant / vowel judgment.
a category change task, which consists in classifying a word according to one category or another according to a visual clue that appears. The task consists of 4 blocks of 48 stimuli.
Intervention Type
Other
Intervention Name(s)
Evaluation of the update
Intervention Description
an update span task for which letters appear on a screen sequentially, and subjects must memorize the last three, without knowing the length of the list. The task will consist of 3 tests of training and then 20 tests. After three errors consecutive, the task ends.
an n-back task that consists of a sequential presentation of letters, during which the subject must indicate when the stimulus. The task consists of 3 levels, with n = 1, n= 2 or n = 3. For level 1 (with n = 1), the subject must press a button when the same letter appears twice in a row on the screen. This task consists of 75 letters.
Intervention Type
Other
Intervention Name(s)
working memory
Intervention Description
the empan baba task, which mainly involves maintaining information, and which consists in retaining a series of letters, appearing sequentially on a screen, and whose latency time between two word presentations is required for a secondary task: the repetition of baba syllables.
the task of reading operations which consists in recalling operations series of letters whose presentation is interspersed with the reading aloud of simple operations and of their results.
the ongoing operational task of recalling a list of letters, the presentation of which is interspersed with operations that are simple to read aloud and to to solve head-on.
Intervention Type
Other
Intervention Name(s)
episodic memory
Intervention Description
- A recognition task with a Remember/Know paradigm
Primary Outcome Measure Information:
Title
Score obtained (the number of correct answers) by participants in tasks evaluating decision-making
Description
measured with two decision-making tasks : Iowa Gambling Task and one experimental task
Time Frame
day 14
Secondary Outcome Measure Information:
Title
Score obtained in task evaluating executive functions
Description
measured with Stroop Victoria
Time Frame
day 14
Title
Score obtained in task evaluating executive functions
Description
measured with Stop Signal on computer
Time Frame
day 14
Title
Score obtained in task evaluating executive functions
Description
measured with a letter-number pair task
Time Frame
day 14
Title
Score obtained in task evaluating executive functions
Description
measured with a category change task.
Time Frame
day 14
Title
Score obtained in task evaluating executive functions
Description
measured with an update span task and a n-back task.
Time Frame
day 14
Title
Score obtained in task evaluating working memory
Description
measured with the task of empan baba.
Time Frame
day 14
Title
Score obtained in task evaluating working memory
Description
measured with the task of reading operations.
Time Frame
day 14
Title
Score obtained in task evaluating working memory
Description
measured with the continuous operation task.
Time Frame
day 14
Title
Scores obtained in tasks evaluating episodic memory
Description
measured with a recognition task with a Remember/Know paradigm
Time Frame
day 14
Title
Scores obtained from the quality of life questionnaire.
Description
measured with Quality of Life in Alzheimer's Disease : it is composed of 13 items (ex: physical health, memory, relationship with friends...). the patient must rate according to 4 possibilities: bad, fairly good, good or excellent. There is one copy to be completed by the patient and another by the caregiver.
Time Frame
day 14
Title
Scores obtained from autonomy questionnaire.
Description
measured with Direct Assessment of Functional Status : assessment of several areas of daily life (spatial and temporal orientation, communication skills, driving, financial management, shopping ability, behaviour food and hygiene). It consists of 7 subscales, allowing each competency to be assessed independently.
Time Frame
day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for patients with Alzheimer's disease :
Mini-Mental State Examination > 23
stable treatment for at least two months
mother tongue : French
Inclusion Criteria for control :
general cognitive level in the standard on the following tests : Mini-Mental State Examination and Fast Front End Efficiency Battery
mother tongue : French
Exclusion Criteria for patients with Alzheimer's disease :
game addiction
uncorrected visual and hearing disorders
other neurological or psychiatric history
inability to communicate
delusional or psychotic state
Exclusion Criteria for control :
game addiction
psychiatric or neurological disorders
anxiety and depression symptomatology
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Céline BORG
Phone
04 77 82 88 82
Email
celine.borg@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Céline BORG
Organizational Affiliation
CHU de Saint Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratoire d'Etude des Mécanismes Cognitifs
City
Bron
ZIP/Postal Code
69676
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Chainay
Phone
04 78 77 43 52
Email
chainay.hanna@univ-lyon2.fr
First Name & Middle Initial & Last Name & Degree
Hanna Chainay
Facility Name
Hôpital Lariboisière- Fernand Widal
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire PAQUET
First Name & Middle Initial & Last Name & Degree
Claire PAQUET, MD
Facility Name
CHU de Saint Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline BORG
Phone
04 77 82 88 82
Email
celine.borg@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Jean Claude GETENET, MD
First Name & Middle Initial & Last Name & Degree
Bernard LAURENT, MD
Facility Name
CMRR - Hôpital Charpennes
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle ROUCH, MD
Phone
(0)472432050
Ext
+33
First Name & Middle Initial & Last Name & Degree
Marie-Hélène COSTE, MD
First Name & Middle Initial & Last Name & Degree
Isabelle ROUCH, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lack of Decision-making in Patients With Alzheimer's Disease : Functions Involved and the Daily Consequences
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