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

NCT04514328 | Withdrawn DMC

• 1 other identifier: A202012345
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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.

  up 20 days

Secondary Outcomes (5)

• cerebral 18F-FDG PET-CT exam

  up 20 days

• Comparison of QCS before and after using the therapeutic garden

  up 18 days

• cerebral 18F-FDG PET-CT exam with QCS

  up 20 days

• Modifications of the score of the electrodermal response during the use of the garden

  up 14 days

• cerebral 18F-FDG PET-CT exam with neuropsychological assessment

  up 20 days

Study Arms (1)

one group

EXPERIMENTAL

patients with mild or moderate Alzheimer disease

Device: cerebral 18F-FDG PET-CT

Interventions

cerebral 18F-FDG PET-CT DEVICE

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

one group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 14, 2020
• Study Start: August 2, 2022
• Primary Completion: October 6, 2022
• Study Completion: January 2, 2023
• Last Updated: August 24, 2022

Record last verified: 2022-08