Alzheimer Disease Clinical Trial
— JAZ ARTOfficial title:
Alzheimer's Disease and Healing Gardens: Study of the Cognitive and Psycho-behavioral Effects of an Artistic Dimension
Gardens and art represent public spaces and support venues of interactions and emotions,
seeking not only a variety of conversational themes but also various cognitive skills such
as mnemonic skills. The cognitive and psycho-behavioral effects of art and the garden,
jointly associated and made available to patients suffering from Alzheimer's disease, need
to be evaluated.
MAIN OBJECTIVE Delineate the psychological scaffolding virtues of art and garden on
cognitive and emotional processes by means of interview analyses in Alzheimer patients and
control subjects based on the " art, memory and life " garden.
SECONDARY OBJECTIVES Adapt eco-psychosocial approaches of care management to Alzheimer
patients:
- create assessment methods of:
- the therapeutic efficacy of the design of the " art, memory and life " garden,
- the perception of an artistic dimension in the living environment of those with
Alzheimer's disease,
- establish:
- workshop applications using art and the garden for therapeutic purposes,
- general recommendations for the layout of the garden. PRIMARY ENDPOINT Quantitative
data of discursive productions stemming from Interlocutory Logic (Trognon and Batt,
2007, 2010, 2011) for the analysis of interactive behaviors and the assessment of
parameters including esthetic appraisals, well-being, mnemonic and emotional processes
(frequency and nature of these processes) as well as spatio-temporal orientation.
SECONDARY ENDPOINTS
- Scores obtained in standard neuropsychological tests, in particular to assess
spatio-temporal orientation (Folstein MMSE),
- Scores obtained with the " MemoArtZ " tool (MAZ) to evaluate the memorization of
artistic elements of the garden,
- Scores from the " General Esthetic Preference " (GEP) tool to evaluate the consistency
of general esthetic appreciations,
- Score obtained with the specific mood assessment scale (CSDD) for subjects in group A,
- Score obtained with the specific assessment of emotional events scale (AES) for all
subjects.
RESEARCH METHODOLOGY
Open, monocentric, controlled (group of healthy control subjects) study.
Population: 2 groups:
Group A "Alzheimer group": patients with mild to severe stages of Alzheimer's disease:
subgroup A1 "Alzheimer group hospitalized at the Paul Spillmann Centre (Centre Paul
Spillmann, CPS)" (CHU de Nancy, France); subgroup A2 "Alzheimer group monitored at the
Resource and Research Memory Centre (Centre Mémoire de Ressources et de Recherche, CMRR)"
(CHU de Nancy, France) Group B "healthy control group": healthy volunteers
Therapeutic fallouts of this study will benefit Alzheimer patients in terms of better care
management, notably: i) by determining the design, conception and layout of the gardens
destined to these patients, ii) by developing the introduction of an artistic dimension to
the design of such healing gardens and in their living environment, iii) by establishing
workshop application perspectives using the contemplation of works of art and the garden for
therapeutic purposes.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | September 2017 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - aged 60 to 100 years - able to walk independently, that is to say without recourse to aid, whether human or technical, except for a simple cane - have never been in the garden " art, memory and life " of the Paul Spillmann Centre - gave their written consent after receiving clear and intelligible written and oral information - with a diagnosis of a probable mild to severe stage of Alzheimer's disease according to NINCDS-ADRDA diagnostic criteria (McKhann et al., 1984) within the last 2 months prior to inclusion - score less than or equal to 4 on the Hachinski Ischemic Scale (Hachinski et al., 1984) within the last 2 months prior to inclusion - Folstein MMSE score between 7 and 24 inclusively within the last 2 months prior to inclusion - score of 4, 5 or 6 on the Reisberg Global Deterioration Scale (Reisberg et al., 1982) within a 2-month delay prior to inclusion - specific drug treatment for Alzheimer's disease, unchanged since at least 2 months (cholinesterase inhibitor and memantine) - no change in psychotropic treatment within 48 hours prior to inclusion Exclusion Criteria: - lack of insurance coverage - sensory deficit interfering with the designated tasks in the study - phasic disorders interfering with the designated tasks in the study - history of head trauma (with loss of consciousness) - chronic alcoholism - refusal or inability to obtain the informed written consent of the subject - persons subject to a legal protection order - severe depression: score > 20 on the GDS (Geriatric Depression Scale) scale at inclusion - other neurological or psychiatric disorders potentially affecting the assessment - current or planned participation to other research involving neuropsychological evaluations and/or drug trial, up until the end of the current study |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
France | CHU Nancy | Nancy |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparaison of the number of language acts in each category between AD and controls subjects | Each interaction between a subject and the psychologist is distributed into a interlocutory analysis table (Trognon and Batt, 2010 ; Batt, Trognon, Rivasseau-Jonveaux, Vernant and Jonveaux, 2014) where each utterance is noticed by its speech turn and its speech act. The second consists of a force (for example, an assertive force, as when I was eight, I loved the garden my parents owned) and a propositional content (for example, a feeling in its episodic context). Propositional content will be described according to its stimulus (for example, a kind of flower growing in the garden, a sculpture put into some place, etc.), to the interaction where it is produced and, more crucially, to the level of memory (procedural/semantics/episodics) it involves. These are the variables that will be then compared in using usual statistics between paired AD and control subjects at visit 1 and 2 | visit2 ( 10 days maximum after visit 1) | No |
Secondary | Scores obtained in standard neuropsychological tests, in particular to assess spatio-temporal orientation (Folstein MMSE), | visit2 ( 10 days maximum after visit 1) | No | |
Secondary | Scores obtained with the " MemoArtZ " tool (MAZ) to evaluate the memorization of artistic elements of the garden, | visit2 ( 10 days maximum after visit 1) | No | |
Secondary | Scores from the " General Esthetic Preference " (GEP) tool to evaluate the consistency of general esthetic appreciations, | visit2 ( 10 days maximum after visit 1) | No | |
Secondary | obtained with the specific mood assessment scale (CSDD) for subjects in group A | visit2 ( 10 days maximum after visit1) | No | |
Secondary | Score obtained with the specific assessment of emotional events scale (AES) for all subjects. | visit2 ( 10 days maximum after visit 1) | No |
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