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Highlighting the Benefits of Therapeutic Gardens in Alzheimer's Disease by 18F-FDG Cerebral PET /CT (JAZTEP)

Primary Purpose

Alzheimer Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cerebral 18F-FDG PET-CT
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    one group

    Arm Description

    patients with mild or moderate Alzheimer disease

    Outcomes

    Primary Outcome Measures

    cerebral 18F-FDG PET-CT exam
    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

    cerebral 18F-FDG PET-CT exam
    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
    QCS is a self-awareness survey to be asked to patients before and after using garden
    cerebral 18F-FDG PET-CT exam with QCS
    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
    Electrodermal response is measured with sensors placed on the skin
    cerebral 18F-FDG PET-CT exam with neuropsychological assessment
    Topography of brain regions, whose carbohydrate metabolism covariates with clinical neuropsychological assessment

    Full Information

    First Posted
    August 10, 2020
    Last Updated
    August 23, 2022
    Sponsor
    Central Hospital, Nancy, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04514328
    Brief Title
    Highlighting the Benefits of Therapeutic Gardens in Alzheimer's Disease by 18F-FDG Cerebral PET /CT
    Acronym
    JAZTEP
    Official Title
    Highlighting the Benefits of Therapeutic Gardens in Alzheimer's Disease by 18F-FDG Cerebral PET /CT
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    the study never opened for pandemic reasons
    Study Start Date
    August 2, 2022 (Anticipated)
    Primary Completion Date
    October 6, 2022 (Anticipated)
    Study Completion Date
    January 2, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Central Hospital, Nancy, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Disease

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    one group
    Arm Type
    Experimental
    Arm Description
    patients with mild or moderate Alzheimer disease
    Intervention Type
    Device
    Intervention Name(s)
    cerebral 18F-FDG PET-CT
    Intervention Description
    cerebral 18F-FDG PET-CT exam after walking in the garden while 2 weeks (75 minutes/per day from Monday to Friday)
    Primary Outcome Measure Information:
    Title
    cerebral 18F-FDG PET-CT exam
    Description
    Topography of brain regions, whose carbohydrate metabolism has significantly changed in cerebral PET / CT with 18F-FDG before and after using the Therapeutic Garden.
    Time Frame
    up 20 days
    Secondary Outcome Measure Information:
    Title
    cerebral 18F-FDG PET-CT exam
    Description
    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.
    Time Frame
    up 20 days
    Title
    Comparison of QCS before and after using the therapeutic garden
    Description
    QCS is a self-awareness survey to be asked to patients before and after using garden
    Time Frame
    up 18 days
    Title
    cerebral 18F-FDG PET-CT exam with QCS
    Description
    Topography of brain regions, whose carbohydrate metabolism covariates with clinical variables (QCS).
    Time Frame
    up 20 days
    Title
    Modifications of the score of the electrodermal response during the use of the garden
    Description
    Electrodermal response is measured with sensors placed on the skin
    Time Frame
    up 14 days
    Title
    cerebral 18F-FDG PET-CT exam with neuropsychological assessment
    Description
    Topography of brain regions, whose carbohydrate metabolism covariates with clinical neuropsychological assessment
    Time Frame
    up 20 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

    Highlighting the Benefits of Therapeutic Gardens in Alzheimer's Disease by 18F-FDG Cerebral PET /CT

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