Alzheimer DiseaseJAZ-TOPNCT01692977
What Elements of the Design of a Healing Garden Are Used as Landmarks by Patients With Alzheimer's Disease to Locate?
A study testing neuropsychological assessment in people with Alzheimer Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The disruption of spatial orientation is considered the second most common cognitive symptom of dementia, affecting nearly all activities of daily living. Research in the field of environmental psychology has helped to highlight the influence of the environment on patients with Alzheimer's disease or related… Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- neuropsychological assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2012to Oct 2014
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- All subjects (groups A and B):
- able to walk autonomously, that is without help, whether human or technical, except for a walking cane
- are aged 65 to 90 years
- have never been in the "art, memory and life" garden at the Paul SPILLMANN Centre prior to the study
- have given their written consent after receiving clear and intelligible oral and written information.
- Group A : patients with Alzheimer's disease:
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- diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA diagnostic criteria (Mc KHANN et al., 1984)
- score less than or equal to 4 on the Hachinski ischemic scale (Hachinski et al., 1984)
- Folstein MMSE score between 10 and 24 inclusively
- score equal to 5 or 6 on the Reisberg Global Deterioration Scale (REISBERG et al., 1982).
- stable, specific treatment of Alzheimer's disease (cholinesterase and memantine)
- taking of psychotropic drugs authorized, but no change in treatment during at least the last 48 hours
- Group B: healthy control subjects:
- absence of dementia according to NINCDS-ADRDA criteria (Mc KHANN et al., 1984)
- normal performance on Folstein MMSE, according to the GRECO (en français : Groupe de REflexions sur les Evaluations Cognitives) standards (Reflection Group on Cognitive Assessments)
Who cannot join
- For all subjects (groups A and B):
- Absence of social security coverage
- sensory deficit interfering with the task
- aphasia interfering with the task
- history of head trauma (with loss of consciousness)
- chronic alcoholism
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- refusal or inability to obtain written informed consent form from the patient
- legally protected person
- severe depression: score higher than 20 on the 30-item Geriatric Depression Scale (GDS)
- Group A : patients with Alzheimer's disease:
- other neurological or psychiatric diseases that may affect the assessment Group B: healthy control subjects
- neurological or psychiatric diseases that may affect the assessment
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital of Nancy , Saint Julien Hospital, France
Nancy, 54000
About this study
Official title: Orienting Oneself in a Healing Garden: What Elements of the Design Are Used as Landmarks by Patients With Alzheimer's Disease ?
The disruption of spatial orientation is considered the second most common cognitive symptom of dementia, affecting nearly all activities of daily living. Research in the field of environmental psychology has helped to highlight the influence of the environment on patients with Alzheimer's disease or related syndromes. With regard to spatial orientation, it has been shown that an environment can provide support for cognitive failures in subjects if that particular space is adapted. While numerous studies have focused on the architectural environment (hospital, housing facility), none have explored the ability of patients to orient themselves in a natural environment such as a garden. Yet, in recent years, such gardens, known as healing gardens, have emerged in housing and care facilities, providing genuine support for the care management of patients with Alzheimer-type dementia. Various works have been published outlining recommendations for their management. However, with regard to spatial orientation, none of the available research has explored the basic principles on which to rely on in order to organize the elements of outdoor spaces into itineraries that promote orientation, according to ZEISEL and TYSON (1999). In the absence of such data, these authors recommend relying on five elements, identified by Lynch in his landmark book "Image of the City" (1960), that people use to orient themselves and find their way. These are " paths ", " edges ", " districts ", " nodes " and " landmarks ". The hypothesis to verify is that patients with Alzheimer's disease do not rely on the same elements of the garden as non-Alzheimer's subjects in making orientation decisions and to mentally picture this environment.
- Conditions
- Alzheimer Disease
- Being tested
- neuropsychological assessment
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropsychological assessmentOther
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer disease patients | Experimental | Alzheimer disease patients Receives: Other: neuropsychological assessment |
| control | Active comparator | healthy control subjects. Receives: Other: neuropsychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze nature and frequency of elements of the " art, memory and life " garden used as landmarks by Alzheimer's disease patients
To describe and compare nature and frequency of elements involved in orientation decisions and the cognitive map, between a group of subjects with Alzheimer's disease and a group of healthy control subjects.
Measured: Baseline = inclusion visit
Secondary outcomes (2)
Study the characteristics of the elements that contributed to decision-making regarding spatial orientation, the cognitive map, correlations between success in experimental, neuropsychological assessment in Alzheimer disease and healthy control subjects.
To identify, through analysis of interviews based on problem solving and interlocutory logic (TROGNON and BATT, 2007,2010, 2011), the characteristics of the elements of the " art, memory and life " garden that contributed to decision-making regarding spatial orientation and the development of a mental representation of the garden, in patients with Alzheimer's disease and healthy elderly subjects.
Measured: Baseline = inclusion visit
Study the characteristics of the elements that contributed to decision-making regarding spatial orientation, the cognitive map, correlations between success in experimental, neuropsychological assessment in Alzheimer disease and healthy control subjects.
To study the correlation between the degree of success in experimental tasks (route learning, cognitive map) and standard and specific neuropsychological assessment (visuospatial skills) of individuals with Alzheimer's disease and healthy control subjects.
Measured: Baseline = inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2014
- Study completionOct 2014
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 Central Hospital, Nancy, FranceThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thérèse Rivasseau Jonveaux, PhD, Principal investigator, University Hospital of Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692977
- Sponsor's protocol ID
- 2011-A00993-38
- Acronym
- JAZ-TOP
- Status last verified
- Jul 2015
- First submitted
- 16 Aug 2012
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orienting Oneself in a Healing Garden: What Elements of the Design Are Used as Landmarks by Patients With Alzheimer's Disease ?
- ClinicalTrials.gov ID
- NCT01692977
- Acronym / sponsor ID
- JAZ-TOP / 2011-A00993-38
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 26 Sep 2012 (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.
The disruption of spatial orientation is considered the second most common cognitive symptom of dementia, affecting nearly all activities of daily living. Research in the field of environmental psychology has helped to highlight the influence of the environment on patients with Alzheimer's disease or related syndromes. With regard to spatial orientation, it has been shown that an environment can provide support for cognitive failures in subjects if that particular space is adapted. While numerous studies have focused on the architectural environment (hospital, housing facility), none have explored the ability of patients to orient themselves in a natural environment such as a garden. Yet, in recent years, such gardens, known as healing gardens, have emerged in housing and care facilities, providing genuine support for the care management of patients with Alzheimer-type dementia. Various works have been published outlining recommendations for their management. However, with regard to spatial orientation, none of the available research has explored the basic principles on which to rely on in order to organize the elements of outdoor spaces into itineraries that promote orientation, according to ZEISEL and TYSON (1999). In the absence of such data, these authors recommend relying on five elements, identified by Lynch in his landmark book "Image of the City" (1960), that people use to orient themselves and find their way. These are " paths ", " edges ", " districts ", " nodes " and " landmarks ". The hypothesis to verify is that patients with Alzheimer's disease do not rely on the same elements of the garden as non-Alzheimer's subjects in making orientation decisions and to mentally picture this environment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer disease patients | Experimental | Other: neuropsychological assessmentAlzheimer disease patients |
| control | Active comparator | Other: neuropsychological assessmenthealthy control subjects. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- able to walk autonomously, that is without help, whether human or technical, except for a walking cane
- are aged 65 to 90 years
- have never been in the "art, memory and life" garden at the Paul SPILLMANN Centre prior to the study
- have given their written consent after receiving clear and intelligible oral and written information.
- diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA diagnostic criteria (Mc KHANN et al., 1984)
Key exclusion criteria (12 listed)
- Absence of social security coverage
- sensory deficit interfering with the task
- aphasia interfering with the task
- history of head trauma (with loss of consciousness)
- chronic alcoholism
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 |
|---|---|---|
| neuropsychological assessment | Other | Alzheimer disease patients, control |
Primary outcome
Analyze nature and frequency of elements of the " art, memory and life " garden used as landmarks by Alzheimer's disease patients
Time frame: Baseline = inclusion visit
To describe and compare nature and frequency of elements involved in orientation decisions and the cognitive map, between a group of subjects with Alzheimer's disease and a group of healthy control subjects.
2 secondary outcomes
Study the characteristics of the elements that contributed to decision-making regarding spatial orientation, the cognitive map, correlations between success in experimental, neuropsychological assessment in Alzheimer disease and healthy control subjects.
Time frame: Baseline = inclusion visit
Study the characteristics of the elements that contributed to decision-making regarding spatial orientation, the cognitive map, correlations between success in experimental, neuropsychological assessment in Alzheimer disease and healthy control subjects.
Time frame: Baseline = inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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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.
Thérèse Rivasseau Jonveaux, PhD principal investigator
University Hospital of Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuropsychological assessment in people with Alzheimer Disease, run by Central Hospital, Nancy, France at 1 site 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 15 inclusion and 12 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: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Analyze nature and frequency of elements of the " art, memory and life " garden used as landmarks by Alzheimer's disease patients (time frame: Baseline = inclusion visit). 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 30 Jul 2015.