Alzheimer DiseaseEMBODIMENTNCT02844855
Memory for Action in Neurological Patients
A study testing Cognitive tests in people with Alzheimer Disease and Parkinson Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Parkinson Disease
- What is being tested?
- Cognitive tests
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Dec 2016to 21 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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
Who cannot join
- 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:
Show all 16Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the detailed description
- = Folstein et al., 1975,
- = Zigmond \& Snaith, 1983,
- = Dubois et al., 2002;
- = Godefroy et al., 2008;
- = Dubois et Pillon, 2000;
- = Mahieux-Laurent, 2009.
- Conditions
- Alzheimer Disease, Parkinson Disease
- Being tested
- Cognitive tests
- Keywords
- Alzheimer, Parkinson, Action memory
- Medical subject headings
- Alzheimer Disease, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive testsBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Behavioral: Cognitive tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of correct answers
The gain provided by the verbal learning vs action learning (number of correct answers).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start26 Dec 2016
- Primary completion21 Feb 2020
- Study completion21 Feb 2020
Why it stopped: failure to recruit 83/99
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline BORG, MD, Principal investigator, celine.borg@univ-st-etienne.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844855
- Sponsor's protocol ID
- 1608068
- Other IDs
- 2016-A00891-50
- Acronym
- EMBODIMENT
- Status last verified
- Sep 2020
- First submitted
- 22 Jul 2016
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory for Action in Neurological Patients
- ClinicalTrials.gov ID
- NCT02844855
- Acronym / sponsor ID
- EMBODIMENT / 1608068
- Conditions
- Alzheimer Disease, Parkinson Disease
- Keywords
- Alzheimer, Parkinson, Action memory
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: failure to recruit 83/99
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 26 Dec 2016 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with Alzheimer disease | Active comparator | Behavioral: Cognitive testsBehavioral: 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 comparator | Behavioral: Cognitive testsBehavioral: 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 comparator | Behavioral: Cognitive testsBehavioral: 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). |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive testsMMSE, (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). | Behavioural | healthy controls, patients with Alzheimer disease, patients with Parkinson disease |
Primary outcome
Number of correct answers
Time frame: Day 1
The gain provided by the verbal learning vs action learning (number of correct answers).
Results and safety
The study was stopped early (reason given: failure to recruit 83/99). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline BORG, MD principal investigator
celine.borg@univ-st-etienne.fr
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive tests in people with Alzheimer Disease and Parkinson Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: failure to recruit 83/99). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of correct answers (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.