NCT02844855

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

December 26, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2020

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

3.2 years

First QC Date

July 22, 2016

Last Update Submit

September 16, 2020

Conditions

Keywords

AlzheimerParkinsonAction memory

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 COMPARATOR

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

patients with Parkinson disease

ACTIVE COMPARATOR

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

healthy controls

SHAM COMPARATOR

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

Interventions

Cognitive testsBEHAVIORAL

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 controlspatients with Alzheimer diseasepatients with Parkinson disease

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Hcl - Cm2R

Villeurbanne, France

Location

MeSH Terms

Conditions

Alzheimer DiseaseParkinson Disease

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathies

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Céline BORG, MD

    celine.borg@univ-st-etienne.fr

    PRINCIPAL INVESTIGATOR

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

Locations