Highlighting the Benefits of Therapeutic Gardens in Alzheimer's Disease by 18F-FDG Cerebral PET /CT (JAZTEP)
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|ClinicalTrials.gov Identifier: NCT04514328|
Recruitment Status : Not yet recruiting
First Posted : August 14, 2020
Last Update Posted : December 14, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Device: cerebral 18F-FDG PET-CT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Highlighting the Benefits of Therapeutic Gardens in Alzheimer's Disease by 18F-FDG Cerebral PET /CT|
|Estimated Study Start Date :||April 2, 2021|
|Estimated Primary Completion Date :||October 6, 2021|
|Estimated Study Completion Date :||January 2, 2022|
Experimental: one group
patients with mild or moderate Alzheimer disease
Device: cerebral 18F-FDG PET-CT
cerebral 18F-FDG PET-CT exam after walking in the garden while 2 weeks (75 minutes/per day from Monday to Friday)
- 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.
- 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.
- 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
- 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).
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514328
|Contact: Antoine VERGER, MD, PhD||383 15 55 67 ext +email@example.com|
|Contact: Véronique ROCH, MsC||383 15 42 76 ext +firstname.lastname@example.org|