Highlighting the Benefits of Therapeutic Gardens in Alzhe... | NCT04514328

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

NCT04514328

Sponsor

Central Hospital, Nancy, France

Status

Withdrawn

Last Update Posted

Aug 24, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Alzheimer Disease

Interventions

cerebral 18F-FDG PET-CT

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

the study never opened for pandemic reasons

Expanded Access Info

Start Date

Aug 2, 2022Estimated

Primary Completion Date

Oct 6, 2022Estimated

Completion Date

Jan 2, 2023Estimated

First Submitted Date

Aug 10, 2020

First Submission Date that Met QC Criteria

Aug 12, 2020

First Posted Date

Aug 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2022

Last Update Posted Date

Aug 24, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
one group	Experimental	patients with mild or moderate Alzheimer disease	Device: cerebral 18F-FDG PET-CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	up 20 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases