Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
83 participants
INTERVENTIONAL
2016-12-26
2020-02-21
Brief Summary
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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.
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Detailed Description
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2. = Zigmond \& Snaith, 1983,
3. = Dubois et al., 2002;
4. = Godefroy et al., 2008;
5. = Dubois et Pillon, 2000;
6. = Mahieux-Laurent, 2009.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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).
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).
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).
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).
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).
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
55 Years
80 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Locations
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CHU de Saint-Etienne
Saint-Etienne, , France
Hcl - Cm2R
Villeurbanne, , France
Countries
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Other Identifiers
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2016-A00891-50
Identifier Type: OTHER
Identifier Source: secondary_id
1608068
Identifier Type: -
Identifier Source: org_study_id
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