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

NCT ID: NCT04514328

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2023-01-02

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

Conditions

Alzheimer Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

one group

patients with mild or moderate Alzheimer disease

Group Type: EXPERIMENTAL

cerebral 18F-FDG PET-CT

Intervention Type: DEVICE

cerebral 18F-FDG PET-CT exam after walking in the garden while 2 weeks (75 minutes/per day from Monday to Friday)

Interventions

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)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Antoine VERGER

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

A202012345

Identifier Type: -

Identifier Source: org_study_id