Study Stopped
failure to recruit 83/99
Memory for Action in Neurological Patients
EMBODIMENT
2 other identifiers
interventional
83
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable alzheimer-disease
Started Dec 2016
Typical duration for not_applicable alzheimer-disease
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedStudy Start
First participant enrolled
December 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2020
CompletedSeptember 17, 2020
September 1, 2020
3.2 years
July 22, 2016
September 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of correct answers
The gain provided by the verbal learning vs action learning (number of correct answers).
Day 1
Study Arms (3)
patients with Alzheimer disease
ACTIVE COMPARATORBehavioral: 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).
patients with Parkinson disease
ACTIVE COMPARATORBehavioral: 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).
healthy controls
SHAM COMPARATORBehavioral: 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).
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
- Probable AD diagnosis made by a neurologist (McKhann et al., 2011)
- Mini-Mental State Examination (MMSE): score \> 22
- Stable treatment for two months minimum.
- 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
You may not qualify if:
- 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
- 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
- \- Motor fluctuations
- Psychiatric or neurological disorders
- Anxiety and depressive symptoms (assessed by the scale of depression-anxiety HAD; Zigmond \& Snaith, 1983)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU de Saint-Etienne
Saint-Etienne, 42055, France
Hcl - Cm2R
Villeurbanne, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Céline BORG, MD
celine.borg@univ-st-etienne.fr
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2016
First Posted
July 26, 2016
Study Start
December 26, 2016
Primary Completion
February 21, 2020
Study Completion
February 21, 2020
Last Updated
September 17, 2020
Record last verified: 2020-09