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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
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
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


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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).

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Antoine VERGER, MD, PhD 383 15 55 67 ext +33 a.verger@chru-nancy.fr
Contact: Véronique ROCH, MsC 383 15 42 76 ext +33 v.roch@chru-nancy.fr

Sponsors and Collaborators
Central Hospital, Nancy, France
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04514328    
Other Study ID Numbers: A202012345
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action