- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04514328
Highlighting the Benefits of Therapeutic Gardens in Alzheimer's Disease by 18F-FDG Cerebral PET /CT (JAZTEP)
The Alzheimer's Plan 2008-2012 allowed the installation of therapeutic gardens for the structures welcoming patients with Alzheimer's disease (AD) . The physical, psychological and social benefits are the improvement of the state of health and overall well-being.
There is a positive role in social interactions for patients with AD who can walk in the therapeutic gardens. Indeed, this promotes meetings with caregives and other people.
Using the garden decreases the stress level in patients (Ulrich). The therapeutic garden named "art, memory and life" in NANCY is based on art, nature and regional culture.
This garden can break with the "artificial" framework of care services often perceived as stressful.
In the garden, people walk around and have an experience that could improve self-image perception.
A clinical study with 2 groups of AD patients hospitalized in UCC or Cognitive Behavioral Unit took place in Nancy. The evaluation of the QCS (questionnaire on self-awareness) was carried out at the beginning and at the end of the study,
- a group of patients went into the garden: the QCS score increased
- a group of patients did not go to the garden (they remained in UCC): the QCS score decreased
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient with AD in the mild to moderate stage, followed at the memory and resource center (CMRR) (MMS 15-23) and having had a 18F-FDG PET-CT (Positon emission tomography) scan in routine care having a companion for the duration of the study .
- Patient with a neuropsychological assessment (MOCA, DO80, BREF, HAD) of less than 3 months. (If the last neuropsychological assessment dates from more than 3 months, these tests are carried out in routine care during the consultation was proposed and the consent obtained)
- Symptomatic treatment of AD (anticholinesterase or memantine) if prescribed, at a stable dose for 1 month, stable psychotropic treatment for 1 month
- Person affiliated with a social security scheme or beneficiary of such a scheme.
- Patient over 18 years old.
- Person received complete information on the organization of the research and having signed their informed consent.
Exclusion Criteria:
- Patient who did not have biomarkers identified by lumbar puncture
- Patient unable to perform a cerebral 18F-FDG PET-CT scan (lying position for more than 20 minutes)
- Patient unable to follow the therapeutic program of the garden.
- Woman of childbearing age whitout effective contraception.
- Pregnant woman or nursing mother.
- Person referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code.
- Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric treatment under articles L. 3212-1 and L. 3213-1
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: one group
patients with mild or moderate Alzheimer disease
|
cerebral 18F-FDG PET-CT exam after walking in the garden while 2 weeks (75 minutes/per day from Monday to Friday)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cerebral 18F-FDG PET-CT exam
Time Frame: up 20 days
|
Topography of brain regions, whose carbohydrate metabolism has significantly changed in cerebral PET / CT with 18F-FDG before and after using the Therapeutic Garden.
|
up 20 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cerebral 18F-FDG PET-CT exam
Time Frame: up 20 days
|
Topography of the brain regions, the carbohydrate metabolism of which has been significantly modified in cerebral PET / CT with 18F-FDG before and after the use of the therapeutic garden by people living with Alzheimer's disease by integrating the actimetry as co-variable in the model.
|
up 20 days
|
Comparison of QCS before and after using the therapeutic garden
Time Frame: up 18 days
|
QCS is a self-awareness survey to be asked to patients before and after using garden
|
up 18 days
|
cerebral 18F-FDG PET-CT exam with QCS
Time Frame: up 20 days
|
Topography of brain regions, whose carbohydrate metabolism covariates with clinical variables (QCS).
|
up 20 days
|
Modifications of the score of the electrodermal response during the use of the garden
Time Frame: up 14 days
|
Electrodermal response is measured with sensors placed on the skin
|
up 14 days
|
cerebral 18F-FDG PET-CT exam with neuropsychological assessment
Time Frame: up 20 days
|
Topography of brain regions, whose carbohydrate metabolism covariates with clinical neuropsychological assessment
|
up 20 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A202012345
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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