Memory for Action in Neurological Patients (EMBODIMENT)

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.

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease; Alzheimer Disease
• Intervention / Treatment: Behavioral: Cognitive tests

Detailed Description

1. = Folstein et al., 1975,
2. = Zigmond & Snaith, 1983,
3. = Dubois et al., 2002;
4. = Godefroy et al., 2008;
5. = Dubois et Pillon, 2000;
6. = Mahieux-Laurent, 2009.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France, 42055
    • CHU de Saint-Etienne
  • Villeurbanne, France
    • Hcl - Cm2R

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: patients with Alzheimer disease; 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; 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).
Active Comparator: patients with Parkinson disease; 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; 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).
Sham Comparator: healthy controls; 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).	Behavioral: Cognitive tests; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of correct answers	The gain provided by the verbal learning vs action learning (number of correct answers).	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Céline BORG, MD, celine.borg@univ-st-etienne.fr

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2016
• Primary Completion (Actual): February 21, 2020
• Study Completion (Actual): February 21, 2020

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Parkinson; Alzheimer; Action memory
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Tauopathies; Parkinson Disease; Alzheimer Disease
• Other Study ID Numbers: 1608068; 2016-A00891-50 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No