search
Back to results

Memory for Action in Neurological Patients (EMBODIMENT)

Primary Purpose

Alzheimer Disease, Parkinson Disease

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive tests
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer Disease focused on measuring Alzheimer, Parkinson, Action memory

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for 3 arms:

  • Patient affiliated to a social security system
  • Age between 55 and 80 years
  • Normal vision and hearing or successfully corrected
  • French mother tongue
  • Signature of consent by participants

Specific criteria for inclusion of MA patients:

  • Probable AD diagnosis made by a neurologist (McKhann et al., 2011)
  • Mini-Mental State Examination (MMSE): score > 22
  • Stable treatment for two months minimum.

Specific criteria for inclusion of PD patients:

  • PD diagnosed by a neurologist (Postuma et al., 2015)
  • Stable treatment for two months minimum.
  • Mini-Mental State Examination (MMSE): score > 27
  • Under dopaminergic treatment

Exclusion Criteria for 3 arms:

  • Other neurological or psychiatric history
  • Anxiety and depressive symptoms (assessed by the scale of depression-anxiety HAD; Zigmond & Snaith, 1983)
  • Inability to communicate
  • Significant impairment of judgment
  • Delusional or psychotic state

Criteria common for non-inclusion of AD and PD patients:

  • Other neurological or psychiatric history
  • Anxiety and depressive symptoms (assessed by the scale of depression-anxiety HAD; Zigmond & Snaith, 1983)
  • Inability to communicate
  • Significant impairment of judgment
  • Delusional or psychotic state

Criteria for non-inclusion of PD patients:

- Motor fluctuations

Criteria for non-inclusion of controls:

  • Psychiatric or neurological disorders
  • Anxiety and depressive symptoms (assessed by the scale of depression-anxiety HAD; Zigmond & Snaith, 1983)

Sites / Locations

  • CHU de Saint-Etienne
  • Hcl - Cm2R

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

patients with Alzheimer disease

patients with Parkinson disease

healthy controls

Arm Description

Behavioral: Cognitive tests Only patients with Alzheimer disease will be included in this arm. Patients will perform different tasks : MMSE, (Folstein et al., 1975), HAD (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983), a cognitive assessment (the 5 words test, Dubois et al., 2002; Trail Making test, Godefroy et al., 2008; BREF, Dubois et Pillon, 2000; Assessment of apraxia, Mahieux-Laurent, 2009) + the experimental task (verbal learning and action learning).

Behavioral: Cognitive tests Only patients with Parkinson disease will be included in this arm. Patients will perform different tasks : MMSE, (Folstein et al., 1975), HAD (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983), a cognitive assessment (the 5 words test, Dubois et al., 2002; Trail Making test, Godefroy et al., 2008; BREF, Dubois et Pillon, 2000; Assessment of apraxia, Mahieux-Laurent, 2009) + the experimental task (verbal learning and action learning).

Behavioral: Cognitive tests Only patients with healthy controls will be included in this arm. Controls will perform different tasks : MMSE, (Folstein et al., 1975), HAD (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983), a cognitive assessment (the 5 words test, Dubois et al., 2002; Trail Making test, Godefroy et al., 2008; BREF, Dubois et Pillon, 2000; Assessment of apraxia, Mahieux-Laurent, 2009) + the experimental task (verbal learning and action learning).

Outcomes

Primary Outcome Measures

Number of correct answers
The gain provided by the verbal learning vs action learning (number of correct answers).

Secondary Outcome Measures

Full Information

First Posted
July 22, 2016
Last Updated
September 16, 2020
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
search

1. Study Identification

Unique Protocol Identification Number
NCT02844855
Brief Title
Memory for Action in Neurological Patients
Acronym
EMBODIMENT
Official Title
Memory for Action in Neurological Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
failure to recruit 83/99
Study Start Date
December 26, 2016 (Actual)
Primary Completion Date
February 21, 2020 (Actual)
Study Completion Date
February 21, 2020 (Actual)

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
Memory for action is especially important in everyday life although current literature is not very abundant. The enactment effect (i.e. better memory for performed actions than for verbally encoded sentences) is usually described as a robust effect in aging and can be found in many diseases. Although the enactment effect has been studied for three decades, there is still no consensus on how it enhances memory. Therefore, in order to gain additional insight into the representational basis of the enactment effect, in the present study, the investigators propose to test neurological patients. The investigators suggested that memory for action should be better than memory for verbally encoded information in Alzheimer's disease and Parkinson's disease. If patients with Alzheimer's disease (AD) and Parkinson's disease (PD) have no cognitive assessment during the last 6 months, then they will realize different tests: MMSE (1), HAD (2), a cognitive assessment (3); (4); BREF (5); Assessment of apraxia, (6). Controls will perform the same tests to verify that they have no cognitive impairment. Then, two experimental conditions will be presented in all patients and controls: a first in which participants will have to name drawings (verbal learning) and a second in which they will have to reproduce an action associated with drawings (action learning). Immediately after this learning phase, a recognition task will be available and therefore participants will have to recognize drawings that had been presented previously. The main criteria used in the statistical analysis will be the correct recognition score.
Detailed Description
= Folstein et al., 1975, = Zigmond & Snaith, 1983, = Dubois et al., 2002; = Godefroy et al., 2008; = Dubois et Pillon, 2000; = Mahieux-Laurent, 2009.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Parkinson Disease
Keywords
Alzheimer, Parkinson, Action memory

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with Alzheimer disease
Arm Type
Active Comparator
Arm Description
Behavioral: Cognitive tests Only patients with Alzheimer disease will be included in this arm. Patients will perform different tasks : MMSE, (Folstein et al., 1975), HAD (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983), a cognitive assessment (the 5 words test, Dubois et al., 2002; Trail Making test, Godefroy et al., 2008; BREF, Dubois et Pillon, 2000; Assessment of apraxia, Mahieux-Laurent, 2009) + the experimental task (verbal learning and action learning).
Arm Title
patients with Parkinson disease
Arm Type
Active Comparator
Arm Description
Behavioral: Cognitive tests Only patients with Parkinson disease will be included in this arm. Patients will perform different tasks : MMSE, (Folstein et al., 1975), HAD (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983), a cognitive assessment (the 5 words test, Dubois et al., 2002; Trail Making test, Godefroy et al., 2008; BREF, Dubois et Pillon, 2000; Assessment of apraxia, Mahieux-Laurent, 2009) + the experimental task (verbal learning and action learning).
Arm Title
healthy controls
Arm Type
Sham Comparator
Arm Description
Behavioral: Cognitive tests Only patients with healthy controls will be included in this arm. Controls will perform different tasks : MMSE, (Folstein et al., 1975), HAD (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983), a cognitive assessment (the 5 words test, Dubois et al., 2002; Trail Making test, Godefroy et al., 2008; BREF, Dubois et Pillon, 2000; Assessment of apraxia, Mahieux-Laurent, 2009) + the experimental task (verbal learning and action learning).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive tests
Intervention Description
MMSE, (Folstein et al., 1975), HAD (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983), a cognitive assessment (the 5 words test, Dubois et al., 2002; Trail Making test, Godefroy et al., 2008; BREF, Dubois et Pillon, 2000; Assessment of apraxia, Mahieux-Laurent, 2009) + the experimental task (verbal learning and action learning).
Primary Outcome Measure Information:
Title
Number of correct answers
Description
The gain provided by the verbal learning vs action learning (number of correct answers).
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for 3 arms: Patient affiliated to a social security system Age between 55 and 80 years Normal vision and hearing or successfully corrected French mother tongue Signature of consent by participants Specific criteria for inclusion of MA patients: Probable AD diagnosis made by a neurologist (McKhann et al., 2011) Mini-Mental State Examination (MMSE): score > 22 Stable treatment for two months minimum. Specific criteria for inclusion of PD patients: PD diagnosed by a neurologist (Postuma et al., 2015) Stable treatment for two months minimum. Mini-Mental State Examination (MMSE): score > 27 Under dopaminergic treatment Exclusion Criteria for 3 arms: Other neurological or psychiatric history Anxiety and depressive symptoms (assessed by the scale of depression-anxiety HAD; Zigmond & Snaith, 1983) Inability to communicate Significant impairment of judgment Delusional or psychotic state Criteria common for non-inclusion of AD and PD patients: Other neurological or psychiatric history Anxiety and depressive symptoms (assessed by the scale of depression-anxiety HAD; Zigmond & Snaith, 1983) Inability to communicate Significant impairment of judgment Delusional or psychotic state Criteria for non-inclusion of PD patients: - Motor fluctuations Criteria for non-inclusion of controls: Psychiatric or neurological disorders Anxiety and depressive symptoms (assessed by the scale of depression-anxiety HAD; Zigmond & Snaith, 1983)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Céline BORG, MD
Organizational Affiliation
celine.borg@univ-st-etienne.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Hcl - Cm2R
City
Villeurbanne
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Memory for Action in Neurological Patients

We'll reach out to this number within 24 hrs