Alzheimer DiseaseJAZTEPNCT04514328
Highlighting the Benefits of Therapeutic Gardens in Alzheimer's Disease by 18F-FDG Cerebral PET /CT
A study testing cerebral 18F-FDG PET-CT in people with Alzheimer Disease, run by Central Hospital, Nancy, France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- cerebral 18F-FDG PET-CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 Aug 2022to 2 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
Read more
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
- Being tested
- cerebral 18F-FDG PET-CT
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebral 18F-FDG PET-CTDevice
cerebral 18F-FDG PET-CT exam after walking in the garden while 2 weeks (75 minutes/per day from Monday to Friday)
| Study group | Role | What they receive |
|---|---|---|
| one group | Experimental | patients with mild or moderate Alzheimer disease Receives: Device: cerebral 18F-FDG PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up 20 days
Secondary outcomes (5)
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.
Measured: up 20 days
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
Measured: up 18 days
cerebral 18F-FDG PET-CT exam with QCS
Topography of brain regions, whose carbohydrate metabolism covariates with clinical variables (QCS).
Measured: up 20 days
Modifications of the score of the electrodermal response during the use of the garden
Electrodermal response is measured with sensors placed on the skin
Measured: up 14 days
cerebral 18F-FDG PET-CT exam with neuropsychological assessment
Topography of brain regions, whose carbohydrate metabolism covariates with clinical neuropsychological assessment
Measured: up 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start2 Aug 2022 (estimated)
- Primary completion6 Oct 2022 (estimated)
- Study completion2 Jan 2023 (estimated)
Why it stopped: the study never opened for pandemic reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine VERGER, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514328
- Sponsor's protocol ID
- A202012345
- Acronym
- JAZTEP
- Status last verified
- Aug 2022
- First submitted
- 10 Aug 2020
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Highlighting the Benefits of Therapeutic Gardens in Alzheimer's Disease by 18F-FDG Cerebral PET /CT
- ClinicalTrials.gov ID
- NCT04514328
- Acronym / sponsor ID
- JAZTEP / A202012345
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the study never opened for pandemic reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 2 Aug 2022 (estimated)
- Primary completion
- 6 Oct 2022 (estimated)
- Study completion
- 2 Jan 2023 (estimated)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group | Experimental | Device: cerebral 18F-FDG PET-CTpatients with mild or moderate Alzheimer disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cerebral 18F-FDG PET-CTcerebral 18F-FDG PET-CT exam after walking in the garden while 2 weeks (75 minutes/per day from Monday to Friday) | Device | one group |
Primary outcome
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.
5 secondary outcomes
cerebral 18F-FDG PET-CT exam
Time frame: up 20 days
Comparison of QCS before and after using the therapeutic garden
Time frame: up 18 days
cerebral 18F-FDG PET-CT exam with QCS
Time frame: up 20 days
Modifications of the score of the electrodermal response during the use of the garden
Time frame: up 14 days
cerebral 18F-FDG PET-CT exam with neuropsychological assessment
Time frame: up 20 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cerebral 18F-FDG PET-CT in people with Alzheimer Disease, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral 18F-FDG PET-CT exam (time frame: up 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.